Radiation Protection in

Radiology—Large Facilities

Safety Procedures for the Installation,

Use and Control of X-ray Equipment
in Large Medical Radiological Facilities

Safety Code 35
Health Canada is the federal department responsible for helping the people of Canada maintain and
improve their health. We assess the safety of drugs and many consumer products, help improve the
safety of food, and provide information to Canadians to help them make healthy decisions. We provide
health services to First Nations people and to Inuit communities. We work with the provinces to ensure
our health care system serves the needs of Canadians.

Published by authority of the

Minister of Health

Également disponible en français sous le titre :

Radioprotection en radiologie—Grands établissements
Procedures de sécurité pour l’installation, l’utilisation et le contrôle des appareils à rayons X
dans les grands établissements radiologiques médicaux
Code de sécurité 35

This publication can be made available on request on

diskette, large print, audio-cassette and braille.

© Her Majesty the Queen in Right of Canada, represented by the Minister of Health, 2008

This publication may be reproduced without permission provided the source is fully acknowledged.

HC Pub.: 4000
Cat.: H128-1/08-545E
ISBN: 978-1-100-10289-4
 3.4 Guidelines for Reduction of Dose to
Sensitive Tissues .......................................................15
Table of Contents 3.5 Diagnostic Reference Levels (DRLs) .......................15
3.5.1 Introduction ..................................................15
Explanatory Notes ...............................................................3
3.5.2 Application ...................................................16
Acknowledgements..............................................................4
3.5.3 Recommended DRL Values...........................16
Introduction .........................................................................5
Principal Objectives of the Safety Code ..............................6 Section B:
Facility and Equipment Requirements .................18
Section A: 1.0 Facility Requirements .............................................18
Responsibilities and Protection................................7 1.1 General Criteria.........................................................18
1.0 Responsibility of Personnel ......................................7 1.2 Design and Plan of X-ray Facility.............................18
1.1 Owner .........................................................................7 1.2.1 Preparation of Facility Plan ...........................18
1.2 Responsible User.........................................................7 1.2.2 Considerations for Room Design
1.3 X-ray Equipment Operator..........................................8 and Layout .....................................................19
1.4 Medical Physicist/Radiation Safety Officer................8 1.2.3 Determination of Parameters Governing
1.5 Referring Physician/Practitioner .................................9 Structural Shielding Requirements................19
1.6 Information Systems Specialist...................................9 1.3 Shielding Calculations ..............................................21
1.7 Repair and Maintenance Personnel...........................10 1.3.1 Radiographic Films .......................................21
1.3.2 Radiographic X-Ray Equipment and
2.0 Procedures for Minimizing Radiation Dedicated Chest Radiographic Equipment....21
Exposure to Personnel ............................................10 1.3.3 Radioscopic X-Ray Equipment and
2.1 General Requirements and Recommendations .........10 Angiographic X-Ray Equipment...................21
2.2 Requirements and Recommendations for 1.3.4 Computed Tomography Equipment...............21
Operation of Mobile Equipment ...............................11
2.3 Requirements and Recommendations for 2.0 Medical X-ray Equipment Requirements.............22
Operation of Radiographic Equipment .....................11 2.1 Regulatory Requirements for
2.4 Requirements and Recommendations for Medical X-ray Equipment.........................................22
Operation of Radioscopic Equipment .......................11 2.2 Equipment Purchasing .............................................22
2.4.1 Requirements and Recommendations 2.2.1 Needs Analysis ..............................................22
for Performing Angiography..........................11 2.2.2 Equipment Specifications ..............................22
2.2.3 Analysis of Vendor Quotation and the
3.0 Procedures for Minimizing Radiation Purchase Contract..........................................22
Exposure to Patients ...............................................12 2.2.4 Acceptance Testing........................................23
3.1 Guidelines for the Prescription of X-ray 2.3 Existing Medical X-ray Equipment ..........................23
Examinations.............................................................12 2.4 Retrofitting with Computed Radiography (CR)
3.2 Guidelines for Radiological Examinations of and Digital Radiography (DR) Systems ...................23
Pregnant Women .......................................................13 2.5 Equipment Specific Requirements ...........................23
3.3 Guidelines for Carrying out X-ray Examinations .....13 2.5.1 General Requirements ...................................23
3.3.1 General Requirements and 2.5.2 Radiographic Equipment Requirements........24
Recommendations ........................................13
2.5.3 Radioscopic Equipment Requirements..........25
3.3.2 Requirements and Recommendations for
2.5.4 Computed Tomography Equipment
Radiographic Procedures...............................14
Requirements.................................................26
3.3.3 Requirements and Recommendations for
2.5.5 Dose and Image Quality Information for
Radioscopic Procedures ................................14
Computed Tomography Equipment...............27
3.3.4 Requirements and Recommendations for
Angiography ..................................................14 3.0 Image Processing Systems ......................................29
3.3.5 Requirements and Recommendations for 3.1 Film-Based Systems..................................................29
Computed Tomography Procedures ..............15 3.1.1 X-ray Film .....................................................29
3.1.2 Cassette and Screen .......................................29
3.1.3 Darkroom.......................................................29

Safety Code 35 1
 3.1.4 Film Processing .............................................30 3.3 Monthly Quality Control Testing .............................46
3.1.5 Viewbox.........................................................31 3.3.1 Quality Control Tests List..............................46
3.2 Digital Imaging Systems...........................................31 3.3.2 Monthly Quality Control Tests ......................47
3.2.1 Computed Radiography Imaging Plates ........31 3.3.3 Monthly Quality Control Tests Equipment ...48
3.2.2 CR Cassette ...................................................31 3.4 Quarterly Quality Control Testing ...........................48
3.2.3 Electronic Display ........................................31 3.4.1 Quality Control Tests List..............................48
3.2.4 Picture Archiving and 3.4.2 Quarterly Quality Control Tests ....................49
Communications System ...............................31 3.4.3 Quarterly Quality Control
3.2.5 PACS Implementation ...................................32 Tests Equipment ............................................49
3.2.6 Teleradiology .................................................33 3.5 Semi-Annual Quality Control Testing .....................50
3.5.1 Quality Control Tests List..............................50
4.0 Other Equipment ....................................................34 3.5.2 Semi-Annual Quality Control Tests ..............50
4.1 Protective Equipment ................................................35 3.5.3 Semi-annual Quality Control
4.2 Test Equipment .........................................................35 Tests Equipment ............................................51
3.6 Annual Quality Control Testing ...............................51
5.0 Radiation Protection Surveys.................................35 3.6.1 Quality Control Tests List..............................51
5.1 General Procedures ...................................................35 3.6.2 Annual Quality Control Tests ........................51
5.2 Survey Report............................................................36 3.6.3 Annual Quality Control Tests Equipment .....55

6.0 Disposal of X-ray Equipment................................37

Appendix I: Dose Limits for Occupational Ionizing
Section C: Radiation Exposures ..........................................................57
Quality Assurance Program...................................38
1.0 Introduction .............................................................38 Appendix II: Shielding Information Guides ...................58
1.1 Goals of the Quality Assurance Program..................38
1.2 Costs-Benefits of the Quality Assurance Program....38 Appendix III: NCRP #49 Methodology for
Calculation of Shielding Requirements for
1.2.1 Costs of Quality Assurance Program.............38
Diagnostic X-ray Installations ...........................................61
1.2.2 Benefits of Quality Assurance Program ........38
1.3 Implementation of Quality Assurance Program........39
Appendix IV: Shielding Guides for Storage of
1.3.1 Policies and Guidelines Development ...........39
Radiographic Film .............................................................67
1.3.2 Establishment of
Quality Control Procedures ...........................40
Appendix V: Federal/Provincial/Territorial
1.3.3 Establishment of
Radiation Safety Agencies.................................................68
Administrative Procedures ............................40

Appendix VI: Radiation Emitting Devices

2.0 Acceptance Testing..................................................41
Regulations for Diagnostic X-ray Equipment ...................70
2.1 Acceptance Testing Evaluation .................................41
Appendix VII: Facility Radiation Protection
3.0 Quality Control Testing Procedures Checklist........ ....................................................................81
and Equipment ........................................................43
3.1 Daily Quality Control Testing ..................................43
Appendix VIII: Radiation Measurement Units ...............85
3.1.1 Quality Control Tests List..............................43
3.1.2 Daily Quality Control Tests...........................43
References ......................................................................86
3.1.3 Daily Quality Control Test Equipment..........44
3.2 Weekly Quality Control Testing ...............................44
3.2.1 Quality Control Tests List..............................44
3.2.2 Weekly Quality Control Tests........................45
3.2.3 Weekly Quality Control Test Equipment.......46

2 Safety Code 35
 This Safety Code does not address radiation protection for
dental and mammography facilities or small radiological
Explanatory Notes facilities such as chiropractic, podiatry, physical therapy and
bone densitometry facilities. For these facilities refer to Health
This document is one of a series of Safety Codes prepared by Canada publications “Safety Code 30, Radiation Protection
Health Canada to set out requirements for the safe use of in Dentistry”, “Safety Code 33, Radiation Protection in
radiation-emitting equipment. Mammography,” and the Safety Code for Small Medical
Radiological Facilities.
This Safety Code has been prepared to provide specific guid-
ance to large medical radiological facilities where diagnostic In a field in which technology is advancing rapidly and where
and interventional radiological procedures are routinely unexpected and unique problems continually occur, this
performed using radiographic, radioscopic or computed to- Code cannot cover all possible situations. Blind adherence to
mography equipment. Large facilities generally operate more rules cannot substitute for the exercise of sound judgement.
than one type of radiological equipment, or have several suites Recommendations may be modified in unusual circumstances,
of the same type of equipment. Most hospitals and computed but only upon the advice of experts in radiation protection.
tomography facilities fall within this category. This Code will be reviewed and revised from time to time, and
a particular requirement may be reconsidered at any time, if
The requirements and recommendations of this safety code do it becomes necessary to cover an unforeseen situation. Inter-
not apply to radiation therapy facilities and the equipment used pretation or elaboration on any point can be obtained by
in radiotherapy, including radiation therapy simulators, for contacting the Consumer and Clinical Radiation Protection
localization and treatment planning. Bureau, Health Canada, Ottawa, Ontario K1A 1C1.

This Safety Code replaces Safety Code 20A and Safety

Code 31.

The information in this Safety Code is intended for owners of

healthcare equipment, physicians, technologists, medical
physicists and other personnel concerned with equipment
performance, image quality and the radiation safety of the
facility.

The personnel requirements, safety procedures, equipment and

facility guidelines and quality assurance measures detailed in
this Safety Code are primarily for the instruction and guidance
of persons employed in Federal Public Service departments
and agencies, as well as those under the jurisdiction of the
Canada Labour Code. Facilities under provincial or territorial
jurisdiction may be subject to requirements specified under
their statutes. The authorities listed in Appendix V should be
contacted for details of the regulatory requirements of indi-
vidual provinces and territories.

The words must and should in this Code have been chosen with
purpose. The word must indicates a requirement that is essen-
tial to meet the currently accepted standards of protection,
while should indicates an advisory recommendation that is
highly desirable and is to be implemented where applicable.

Safety Code 35 3
Acknowledgements
This document reflects the work of many individuals. It
was prepared and compiled by Mr. Christian Lavoie and
Ms. Narine Martel of the Medical X-ray and Mammography
Division, Consumer and Clinical Radiation Protection Bureau.
Appreciation is expressed to Mr. Yani Picard and other mem-
bers of the Medical X-ray and Mammography Division for
their assistance and advice during the preparation of this code.

The contributions of the following organizations, agencies and

associations whose comments and suggestions helped in the
preparation of this code are gratefully acknowledged:

Alberta Cancer Board

Alberta College of Medical Diagnostic and Therapeutic
Technologists
Alberta Employment, Immigration and Industry
British Columbia Centre for Disease Control
Canadian Association of Radiologists
Canadian Nuclear Safety Commission
Cancercare Manitoba
College of Physicians and Surgeons of Alberta
Hôpital Dr G.-L Dumont, Moncton, New Brunswick
Ontario Association of Medical Radiation Technologists
Ontario Safety Association for Community and
Healthcare
Queen Elizabeth Hospital, Charlottetown,
Prince Edward Island
Saskatchewan Association of Health Organizations
Vancouver General Hospital, British Columbia
WorkSafe BC
Workers’Compensation Board Northwest Territories and
Nunavut

4 Safety Code 35
 Since it is not possible to measure carcinogenic effects at low
doses, estimates of the incidences of radiation effects at low
Introduction doses are based on linear extrapolation from relatively high
doses. Due to the uncertainties with respect to radiological
Diagnostic and interventional radiology, are an essential part risk, a radiation protection risk model assumes that the health
of present day medical practice. Advances in X-ray imaging risk from radiation exposure is proportional to dose. This is
technology, together with developments in digital technology called the linear no-threshold hypothesis. Since the projected
have had a significant impact on the practice of radiology. This effect of a low dose increases the incidence of a deleterious
includes improvements in image quality, reductions in dose effect only minimally above the naturally occurring level, it is
and a broader range of available applications resulting in impossible to prove by observation either the validity or falsity
better patient diagnosis and treatment. However, the basic prin- of this hypothesis. However, the linear no-threshold hypothe-
ciples of X-ray image formation and the risks associated with sis has been widely adopted in radiological protection and has
X-ray exposures remain unchanged. X-rays have the potential led to the formulation of the ALARA (As Low As Reasonably
for damaging healthy cells and tissues, and therefore all Achievable) principle. The ALARA principle is an approach
medical procedures employing X-ray equipment must be care- to radiation protection to manage and control exposures to
fully managed. In all facilities and for all equipment types, radiation workers and the general public to as low as is
procedures must be in place in order to ensure that exposures reasonable, taking into account social and economic factors.
to patients, staff and the public are kept as low as reasonably
achievable. In radiology, there are four main aspects of radiation protection
to be considered. First, patients should not be subjected to
Diagnostic X-rays account for the major portion of man-made unnecessary radiographic procedures. This means that the
radiation exposure to the general population. Although indi- procedures are ordered with justification, including clinical
vidual doses associated with conventional radiography are examination, and when the diagnostic information cannot
usually small, examinations involving computed tomography be obtained otherwise. Second, when a procedure is required,
and radioscopy can be significantly higher. However, with it is essential that the patient be protected from excessive
well-designed, installed and maintained X-ray equipment, and radiation exposure during the examination. Third, it is neces-
through use of proper procedures by trained operators, unnec- sary that personnel within the facility be protected from
essary exposure to patients can be reduced significantly, with excessive exposure to radiation during the course of their
no decrease in the value of medical information derived. To work. Finally, personnel and the general public in the vicinity
the extent that patient exposure is reduced, there is, in general, of such facilities require adequate protection.
a decrease in the exposure to the equipment operators and
other health care personnel. While regulatory dose limits have been established for radia-
tion workers and the general public, these limits do not apply
The need for radiation protection exists because exposure to to doses received by a patient undergoing medical X-ray
ionizing radiation can result in deleterious effects that manifest procedures. For patients, the risk associated with the exposure
themselves not only in the exposed individuals but in their to radiation must always be weighed against the clinical
descendants as well. These effects are called somatic and benefit of an accurate diagnosis or treatment. There must
genetic effects, respectively. Somatic effects are characterized always be a conscious effort to reduce patient doses to the
by observable changes occurring in the body organs of the lowest practical level consistent with optimal quality of diag-
exposed individual. These changes may appear within a time nostic information. Through close cooperation between
frame of a few hours to many years, depending on the amount medical professionals, technologists, medical physicists, and
and duration of exposure to the individual. Genetic effects are other support staff it is possible to achieve an effective radia-
an equal cause for concern at the lower doses used in diag- tion protection program and maintain a high quality medical
nostic radiology. Although the radiation dose may be small imaging service.
and appear to cause no observable damage, the probability of
chromosomal damage in the germ cells, with the consequence
of mutations giving rise to genetic defects, can make such
doses significant for large populations.

Safety Code 35 5
 This Safety Code is composed of three sections:

Principal Objectives of the Section A: Responsibilities and Protection

Safety Code This section sets out the responsibilities of the owner,
This Safety Code is concerned with the protection of all responsible user, operators and other staff for the safe
individuals who may be exposed to radiation emitted by X-ray installation, operation and control of the equipment, and
equipment used in a large radiological facility. The aim of sets out practices to minimize radiation doses to patients,
this Safety Code is to provide radiological facilities with staff and the public.
the necessary information to achieve the following principal
objectives: Section B: Facility and Equipment Requirements

1. to minimize patient exposure to ionizing radiation This section sets out requirements for the facility design
while ensuring the necessary diagnostic information and minimum equipment construction and performance
is obtained and treatment provided; standards.
2. to ensure adequate protection of personnel operating
X-ray equipment; Section C: Quality Assurance Program
3. to ensure adequate protection of other personnel and
the general public in the vicinity of areas where X-ray This section sets out requirements for quality assurance
equipment is used. programs including acceptance testing and quality
control procedures.
To assist personnel in achieving these objectives, this Safety
Code:

A. sets out relative responsibilities of the owner, the

X-ray equipment operator, the responsible user, the
medical physicist or radiation safety officer, the
referring physician, the information systems special-
ist, and the repair and maintenance personnel;
B. presents practices and procedures to minimize doses
from X-ray equipment to operators and the public;
C. presents practices and procedures for minimizing
radiation doses to patients while maintaining ade-
quate image quality;
D. presents practices and procedures for ensuring the
X-ray equipment is used in a safe manner;
E. provides information on facility design and shielding
requirements;
F. specifies minimum standards of construction and per-
formance for X-ray equipment;
G. supplies information required to implement and
operate a quality assurance program for the facility;
H. provides a list of acceptance tests and quality control
tests for various types of X-ray equipment and their
accessories; and
I. provides a schedule for performing quality control
tests.

6 Safety Code 35
Section A:
Responsibilities and Protection
2. acquire re-qualification or refresher training according to
any applicable federal, provincial, or territorial regulations or
1.0 Responsibility of Personnel statutes and according to a recognized standard, such as
i) for physicians, the Royal College of Physicians and
Although staff responsibilities described below are grouped Surgeons of Canada or by the Collège des
separately, to obtain the optimal level of radiation safety and médecins du Québec, or
image quality, it is imperative that full cooperation exists
among all concerned parties. ii) for technologists, the Canadian Association of
Medical Radiation Technologists or l’Ordre des
technologues en radiologie du Québec;
1.1 Owner 3. ensure that the X-ray equipment, image processing equip-
ment, and auxiliary equipment function correctly and are
The owner is ultimately responsible for the radiation safety of maintained properly by implementing and maintaining
the facility. It is the responsibility of the owner to ensure that an effective imaging quality assurance program for the
the equipment and the facilities in which such equipment is facility, including quality control testing, establishing
installed and used meet all applicable radiation safety stan- diagnostic reference levels, and record keeping;
dards, and that a radiation safety program is developed,
4. ensure that the equipment is used correctly, and main-
implemented and maintained for the facility. The owner may
tained properly, by competent personnel who are properly
delegate this responsibility to qualified staff. How this
trained in the safe operation of the equipment;
responsibility is delegated will depend upon the number of
staff members, the nature of the operation, and on the number 5. ensure that inexperienced personnel, including students,
of X-ray equipment owned. In any event, the owner must en- operate the equipment only under the direct supervision of a
sure that one or more qualified persons are designated to carry licensed, certified, and experienced X-ray equipment operator
out the roles described below. until competence in a given clinical procedure is achieved,
at which time supervision should be indirectly provided by a
supervisor available on-site when needed;
1.2 Responsible User 6. establish documented safe operating procedures for the
equipment and ensure that operating staff are adequately
The main role of the responsible user is to monitor and instructed in them;
manage the radiation safety program of the facility including
personnel requirements, equipment performance and safety 7. promulgate documented rules of radiation safety and
procedures and to communicate program information with the ensure that staff are made aware of them through training;
appropriate staff. There must be at least one person designated 8. ensure an investigation is completed of any known or
as the responsible user. If the responsible user also performs suspected exposures received by personnel that are
patient examinations, then all of the requirements listed in (a) unusually higher than the usual dose received by that
section A1.3 for the X-ray equipment operator must also be individual, or
met. The responsible user must:
(b) in excess of 1/20th of the dose limit for radiation
workers, specified in Appendix I;
1. possess qualifications for operating the equipment
9. ensure that radiation levels in controlled and uncontrolled
required by any applicable federal, provincial, or territorial
areas are below the maximum permissible limits such that the
regulations or statutes and be certified according to a recog-
annual dose limits to radiation workers and the public, given
nized standard, such as
in Appendix I, will not be exceeded;
i) for physicians, the Royal College of Physicians and
10. ensure that an effective communication system is main-
Surgeons of Canada or by the Collège des
tained between X-ray equipment operators, referring physi-
médecins du Québec, or
cians, medical physicists/Radiation Safety Officers and
ii) for technologists, the Canadian Association of information systems specialists to discuss all matters related to
Medical Radiation Technologists or l’Ordre des radiation protection of patients and workers; and
technologues en radiologie du Québec;
11. ensure that the Medical Physicist/Radiation Safety Officer
and all operators are provided with a copy of this Safety Code.

Safety Code 35 7
1.3 X-ray Equipment Operator 8. have document clinical training, in accordance to federal,
provincial, or territorial statutes and regulations and any
All X-ray equipment operators have the responsibility of relevant professional standards, on new radiological
carrying out prescribed radiological procedures in a manner procedures before commencing independent work on
which does not cause any unnecessary exposures to patients, patients;
themselves and other workers in the facility. Depending on the
9. strive to eliminate unnecessary radiographic procedures
type of radiological procedure, the equipment may be oper-
by reducing the number of retakes, and reducing all
ated by a physician, a physician/practitioner or a radiation
patient radiation exposures to the lowest practical values;
technologist.
10. participate fully in the established quality assurance
All operators must: program for the facility, including reporting any change in
equipment performance to the responsible user; and
1. possess qualifications required by any applicable federal,
provincial, or territorial regulations or statutes and be 11. understand the recommendations of this Safety Code.
certified according to a recognized standard, such as
i) for physicians, the Royal College of Physicians and
Surgeons of Canada or by the Collège des 1.4 Medical Physicist/Radiation
médecins du Québec, or Safety Officer
ii) for technologists, the Canadian Association of There must be a Medical Physicist or Radiation Safety Officer
Medical Radiation Technologists or l’Ordre des to act as an advisor on all radiation protection aspects during
technologues en radiologie du Québec; the initial stages of construction of the facility, installation of
2. acquire re-qualification or refresher training according to the equipment, and during subsequent operations. Medical
any applicable federal, provincial, or territorial regulations or physicists are health care professionals with specialized train-
statutes and according to a recognized standard, such as ing in the medical applications of physics. A radiation safety
i) for physicians, the Royal College of Physicians and officer is the title commonly assigned to a radiation safety spe-
Surgeons of Canada or by the Collège des cialist who routinely manages a facilities radiation protection
médecins du Québec, or program.

ii) for technologists, the Canadian Association of The medical physicist /radiation safety officer must:
Medical Radiation Technologists or l’Ordre des
technologues en radiologie du Québec; 1. possess qualifications required by any applicable federal,
provincial, or territorial regulations or statutes and be
3. have documented training in certified according to a recognized standard, such as
i) the safe operation of the X-ray equipment and i) for medical physicists, the Canadian College of
accessories used in the facility, Physicists in Medicine;
ii) the radiological procedure being performed, 2. acquire re-qualification or refresher training according to
iii) patient positioning for accurate localization of any applicable federal, provincial, or territorial regulations or
regions of interest, statutes and according to a recognized standard, such as
iv) all manufacturer-specified quality assurance i) for medical physicists, the Canadian College of
procedures, if necessary; and Physicists in Medicine;
v) radiation protection procedures and measures. 3. ensure that the installation complies with all applicable
4. be familiar with, and have access to, the manufacturer’s regulatory requirements, by
operator manual for the specific equipment used in the i) assessing the radiation safety of an installation
facility; at the time of planning and/or construction of the
5. recognize the radiation hazards associated with their work facility, or when modifications are planned and/or
and take measures to minimize them; being made to an existing facility,
6. monitor their radiation exposures with the use of a ii) registering the equipment with the appropriate
personal dosimeter, if they are likely to receive a dose in excess agency when new equipment is purchased, and
of 1/20th of the dose limit to radiation workers specified in iii) setting periodic scheduled inspections for the
Appendix I; facility. In some jurisdictions, the agency respon-
7. have a thorough understanding of safe working methods sible for inspections has the mandate for setting
and appropriate techniques and procedures, including the inspection schedules;
appropriate use of personal protective equipment;

8 Safety Code 35
4. establish safe working conditions according to the territorial radiation safety agencies, listed in Appendix V, for
recommendations of this Safety Code and the statutory information on any applicable provincial or territorial statutes
requirements of federal, provincial, or territorial legislation, or regulations.
where applicable;
5. ensure that established safety procedures are being fol- The referring physician/practitioner must:
lowed and report any non compliance to the responsible user; 1. possess qualifications required by any relevant federal,
6. review the safety procedures periodically and update them provincial, or territorial regulations or statutes and be
to ensure optimum patient and operator safety; licensed according to a recognized standard such as
7. instruct X-ray equipment operators and other personnel i) the Royal College of Physicians and Surgeons of
participating in X-ray procedures in proper radiation Canada or by the Collège des médecins du Québec;
protection practices; 2. acquire re-qualification or refresher training according to
8. carry out routine checks of equipment and facility safety any applicable federal, provincial, or territorial regulations or
features and radiation surveys; statutes and according to a recognized standard, such as
9. ensure that appropriate radiation survey instruments are i) for physicians, the Royal College of Physicians and
available, in good working condition, and properly Surgeons of Canada or by the Collège des
calibrated; médecins du Québec;
10. keep records of radiation surveys, including summaries 3. prescribe an X-ray examination based on professional
of corrective measures recommended and/or instituted (refer to experience, judgement and common sense;
section B5.1); 4. give consideration to alternative, non X-ray utilizing,
11. declare who is to be considered an occupationally exposed examinations;
person (ie. personnel who may receive a radiation dose in
excess of 1/20th of the recommended dose limit for a and should:
radiation worker, as specified in Appendix I); 1. be confident that the procedure will improve the patient
12. organize participation in a personnel radiation monitor- diagnosis and/or treatment sufficiently in comparison with
ing service, such as that provided by the National Dosimetry alternate, non X-ray utilizing, methods of diagnosis and/or
Services, Health Canada, Ottawa, Ontario K1A 1C1; treatment;
13. ensure that all occupationally exposed persons wear 2. be aware of the risks associated with X-ray procedures.
personal dosimeters during radiological procedures or when
occupational exposures are likely;
14. review, manage and maintain records of occupational
1.6 Information Systems Specialist
exposures received by personnel; Facilities performing digital image processing should have
15. investigate each known or suspected case of excessive or access to an individual who is trained and experienced in main-
abnormal exposure to patients and staff to determine the cause tenance and quality control of information technology soft-
and to take remedial steps to prevent its recurrence; ware and hardware such as those for PACS and teleradiology
16. participate in the establishment of diagnostic reference equipment. Depending on the facility, the individual may be
levels; and on-site or available upon request. The required qualification
of this individual will depend highly on the type of facility and
17. understand the recommendations of this Safety Code. the type of equipment used in the facility. In all situations, the
information systems specialist must ensure confidentiality of
patient records.
1.5 Referring Physician/Practitioner
The information systems specialist should:
The referring physician/practitioner is the individual
authorised to prescribe diagnostic or interventional X-ray 1. be educated and experienced in information technology;
procedures. The main responsibility of the referring physi- 2. possess equipment-specific training provided by manu-
cian/practitioner is to ensure that the use of X-rays is justified. facturers, where available;
In some jurisdictions, a registered nurse or nurse practitioner 3. be knowledgeable of networking concepts such as
may be authorised by legislation to order X-ray examination. DICOM and HL7;
In such cases, the responsibilities of the referring physician/
practitioner listed below would apply to those individuals. It 4. be familiar with the workflow of the facility;
is recommended to contact the appropriate provincial or 5. understand the policies and procedures in place within the
facility;

Safety Code 35 9
6. understand the importance of and the requirements for an
information systems quality assurance program;
7. communicate with staff any changes/upgrades made to the 2.0 Procedures for
information management equipment hardware or software and Minimizing Radiation
the resulting consequences on the operating procedures of the
facility. Exposure to Personnel
The required and recommended procedures outlined in this
section are primarily directed toward occupational health
1.7 Repair and Maintenance Personnel protection. However, adherence to these will also, in many
The repair and maintenance personnel are individuals instances, provide protection to visitors and other individuals
authorised to perform hardware and software repairs and in the vicinity of an X-ray facility. The safe work practices and
maintenance on X-ray generators, control systems, imaging procedures should be regarded as a minimum, to be augmented
systems and their operating software. Depending on the facil- with additional requirements, when warranted, to cover
ity, these individuals may be on-site or available upon request, special circumstances in particular facilities.
but in general, this function is sometime contracted to an
outside organization, or to the equipment manufacturer. The To achieve optimal safety, responsible users and equipment
required qualification of this individual will depend highly on operators must make every reasonable effort to keep exposures
the type of facility and the type of equipment used in the to themselves and to other personnel as far below the limits
facility. specified in Appendix I as reasonably achievable.

The repair and maintenance personnel should:

2.1 General Requirements and
1. have knowledge and training in
Recommendations
(i) repair and maintenance of radiological imaging
equipment, and 1. An X-ray room must not be used for more than one
(ii) radiation protection principles and procedures; radiological investigation simultaneously.
2. ensure that, after a repair or maintenance procedure, 2. Except for those persons whose presence is essential,
the equipment meets the required regulatory standards or all persons must leave the room when the irradiation is carried
manufacturer’ specifications; out.
3. ensure that all repair and maintenance procedures are 3. Personnel must, at all times, keep as far away from
properly recorded and communicated to the responsible user the X-ray beam as practicable. Direct radiation exposure of
and other appropriate staff; personnel by the primary X-ray beam must never be allowed.
4. report any non compliance with the established safety 4. Deliberate irradiation of an individual for training
procedures to the responsible user; purposes or equipment evaluation must never occur.
5. review the maintenance procedures periodically and 5. All personnel must use available protective devices
update them to ensure optimum patient and operator safety; (refer to section B4.1).
6. communicate, if necessary, to staff the need for the 6. All operators of X-ray equipment, together with person-
appropriate acceptance testing, baseline setting and quality nel (i.e., nurses) who routinely participate in radiological
control testing; and procedures, and others, likely to receive a radiation dose in
7. follow manufacturers’ recommendations for the repair and excess of 1/20th of the dose limit to radiation workers speci-
maintenance of equipment. fied in Appendix I, must be declared radiation workers and
monitor their radiation exposures with the use of a personal
dosimeter.
7. Personal dosimeters must be worn and stored according to
the recommendations of the dosimetry service provider. When
a protective apron is worn, the personal dosimeter must be
worn under the apron. If extremities are likely to be exposed
to significantly higher doses, additional dosimeters should be
worn at those locations on the body.
8. All personal dosimetry records must be maintained for the
lifetime of the facility.

10 Safety Code 35
9. A female operator should immediately notify her 2.3 Requirements and
employer upon knowledge that she is pregnant, in order that Recommendations for Operation
appropriate steps may be taken to ensure that her work duties
during the remainder of the pregnancy are compatible with the
of Radiographic Equipment
recommended dose limits as stated in Appendix I. Depending
1. The irradiation should, as a general rule, be controlled
on the type of facility and on the type of work being performed
from the control panel located in a shielded area.
by the employee, it may not be necessary to remove a preg-
Operators should remain in the shielded area. In the case of
nant staff member from their duties of operating the X-ray
special techniques where the operator is required to control
equipment. It is recommended that the decision to remove
the irradiation while at the side of the patient, appropriate
pregnant workers from their duties include consideration of
protective clothing, in accordance with the requirements of
the radiation exposure risks associated with the employees
section B4.1, must be worn.
duties, as determined by a medical physicist or a radiation
safety officer. 2. The operator must have a clear view of the patient during
every X-ray examination and must be able to communicate
10. Where there is a need to support weak patients or to
with the patient and/or attendants without leaving the control
support or comfort children, holding devices should be used.
booth.
If parents, escorts or other personnel are called to assist, they
must be provided with protective aprons and gloves, and be 3. Radiographic cassettes must never be held by hand during
positioned so as to avoid the X-ray beam. No person should an irradiation.
regularly perform these duties.
11. All entrance doors to an X-ray room should be kept closed
while a patient is in the room and must be closed while 2.4 Requirements and
making an X-ray exposure. Recommendations for Operation
12. X-ray machines which are energized and ready to produce of Radioscopic Equipment
radiation must not be left unattended.
1. All persons, with the possible exception of the patient,
required to be in the room during radioscopy and spotfilm
operation associated with the radioscopic operation must wear
2.2 Requirements and
protective aprons. Lead shields or curtains mounted on the
Recommendations for Operation radioscopic unit are not a sufficient substitute for the wearing
of Mobile Equipment of personal protective clothing such as lead aprons.
2. Protective gauntlets should be worn by the radiologist
1. Mobile units should be used only if the condition of
during palpation in every radioscopic examination.
the patient is such as to make it inadvisable for the examina-
During radioscopy, palpation with the hand should be kept to
tion to be carried out with a stationary unit in the main X-ray
a minimum.
department.
3. All radioscopic examinations should be carried out as
2. During operation, the X-ray beam should be directed
rapidly as possible using minimum dose rates and X-ray field
away from occupied areas if at all possible, and every
size.
effort must be made to ensure that this beam does not
irradiate any other persons in the vicinity of the patient. 4. For each type of radioscopic procedure, an assessment
should be made of the physical positions of all personnel
3. The operator must not stand in the direction of the direct
to ensure ease of operation of the equipment, visibility of the
beam and must be least 3 metres from the X-ray tube
display, and protection from the radiation field.
unless wearing personal protective equipment or standing
behind a leaded shield.
2.4.1 Requirements and Recommendations for
4. In a capacitor discharge unit, after an X-ray irradiation Performing Angiography.
has been made, there is a residual charge left in the
Angiography is potentially one of the greatest sources of
capacitors. The residual charge can give rise to a “dark
exposure to personnel in radiology, since it requires the pres-
current” and result in X-ray emission even though the
ence of a considerable number of personnel close to the
irradiation switch is not activated. Therefore, the residual
patient, radioscopy for extended periods of time and multiple
charge must be fully discharged before the unit is left
radiographic exposures. For such procedures, all personnel
unattended.
must be aware of the radiation hazards involved and make
every effort to adhere to the following requirements and
recommendations.

Safety Code 35 11
1. Full use must be made of the protective devices provided 3.1 Guidelines for the
with X-ray equipment such as shielded panels, drapes, bucky Prescription of
slot covers, ceiling-suspended lead acrylic screens, etc.
X-ray Examinations
2. The patient is the largest source of scatter radiation. To
avoid this scatter, operate the equipment with the tube under Unnecessary radiation exposures of patients can be signifi-
the patient and, if the tube is horizontal, stand on the side of the cantly reduced by ensuring that all examinations are clinically
image receptor. justified. This can be done by adhering, as much as possible,
3. All personnel must wear protective clothing and person- to certain basic recommendations. These recommendations are
nel dosimeters. Protective glasses should also be worn. presented below.

4. All personnel who are not required to be immediately

adjacent to the patient during the procedure must stand back as 1. The prescription of an X-ray examination of a patient
far as possible from the patient, while still able to effectively should be based on clinical evaluation of the patient and should
carry out their duties and, if at all possible, should stand behind be for the purpose of obtaining diagnostic information or
a protective shield. patient treatment.

5. Special shields in addition to the protective devices 2. X-ray examinations should not be performed if there has
provided with the machine should be used. been no prior clinical examination of the patient.
3. Radiological screening must not be performed unless,
it has been proven that the benefit to the individual
examined or the population as a whole is sufficient enough to
warrant its use.
3.0 Procedures for
4. It should be determined whether there have been any pre-
Minimizing Radiation vious X-ray examinations which would make further
Exposure to Patients examination unnecessary, or allow for the ordering of
an abbreviated examination. Relevant previous images or
The largest single contributor of man-made radiation exposure reports should be examined along with a clinical
to the population is dental and medical radiography. In total, evaluation of the patient.
such use of X-rays accounts for more than 90 % of the total
man-made radiation dose to the general population. 5. When a patient is transferred from one physician or
hospital to another any relevant images, or reports should
The risk to the individual patient from a single radiographic accompany the patient and should be reviewed by the
examination is very low. However, the risk to a population is consulting physician.
increased by increasing the frequency of radiographic exami- 6. When prescribing a radiological examination, the physi-
nations and by increasing the number of persons undergoing cian should specify precisely the clinical indications and
such examinations. For this reason, it is important to reduce information required.
the number of radiographs taken, the number of persons 7. The number of radiographic views required in an
examined radiographically, and the doses associated with the examination must be kept to the minimum practicable,
examinations. consistent with the clinical objectives of the examination.
8. Before performing X-ray examinations on females of
To accomplish this reduction, it is essential that patients must
child bearing age (11-55 years), the patient must be asked
only be subjected to necessary radiological examinations and,
whether there is any chance that they may be pregnant. Radi-
when a radiological examination is required, patients must be
ological examinations of the pelvic area in women of child-
protected from excessive irradiation during the examination.
bearing age should be undertaken in the ten-day
period following the onset of menstruation, since the risk of
The required and recommended procedures for the protection
pregnancy is very small during this period. Care must be taken
of the patient, outlined in this section, are directed toward the
to protect the foetus from radiation when the
physician/practitioner, radiologist, and technologist. They are
X-ray examination is not avoidable. The guidelines in
intended to provide guidelines for elimination of unnecessary
section A3.2 for radiological examinations of pregnant women
radiological examinations and for minimizing doses to patients
should be followed.
when radiological examinations are necessary.
9. If a radiograph contains the required information, repeat
procedures must not be prescribed simply because the
radiograph is not of the “best” diagnostic quality.
10. Specialized studies should be undertaken only by, or in
close collaboration with a qualified radiologist.

12 Safety Code 35
11. A patient’s clinical records should include details of 3.3 Guidelines for Carrying Out
X-ray examinations carried out. X-ray Examinations
More specific guidance for the prescription of imaging Next to elimination of unnecessary X-ray examinations, the
examinations is available from the Canadian Association of most significant factor in reducing patient exposure is ensur-
Radiologists (CAR) in their Diagnostic Imaging Referral ing that only necessary examinations are performed with good
Guidelines (CAR 2005). These guidelines provide recom- technique. It is possible, for example, to obtain a series of
mendations on the appropriateness of imaging investigations diagnostically-acceptable radiographs and have the patient
for the purpose of clinical diagnosis and management of exposures vary widely because of choice of technique and
specific clinical/diagnostic problems. The objective of these loading factors used. It is the responsibility of the operator and
guidelines is to aid the referring physician/practitioner to select radiologist to be aware of this and to know how to carry out a
the appropriate imaging investigation and thereby reduce un- prescribed examination with the lowest possible exposure to
necessary imaging by eliminating imaging that is not likely the patient.
to be of diagnostic assistance to a particular patient and by
suggesting alternative procedures that do not use ionizing The requirements and recommendations that follow are
radiation but offering comparable diagnostic testing accuracy. intended to provide guidance to the operator and radiologist
in exercising their responsibility toward reduction of patient
exposure.
3.2 Guidelines for Radiological
Examinations of Pregnant Women 3.3.1 General Requirements and
Recommendations
Radiological examinations of the pelvic area of a woman
known to be pregnant simultaneously irradiate the patient’s 1. The operator must not perform any examination which
gonads and the whole body of the foetus. Irradiation of the un- has not been prescribed.
born foetus increases the infant’s risk of somatic effects and 2. The exposure of the patient must be kept to the lowest
also carries the risk of genetic effects in subsequent offspring. practicable value, consistent with clinical objectives and with-
Therefore, every effort should be made to avoid unnecessary out loss of essential diagnostic information. To achieve this,
irradiation of any woman known to be, or who might be preg- techniques appropriate to the equipment available should be
nant. Clearly, however, in spite of the possibility of radiation used.
damage, if a radiological examination is required for the diag- 3. Particular care, consistent with the recommendations of
nosis or management of an urgent medical problem, it must section A3.2, must be taken when radiological examinations of
be done, irrespective of whether the patient may or may not pregnant or potentially pregnant women are carried out.
be pregnant.
4. The X-ray beam must be well-collimated to restrict it as
much as is practicable to the area of diagnostic interest.
The following recommendations apply to X-ray examinations
involving pregnant or potentially pregnant women: 5. The X-ray beam size must be limited to the size of the
image receptor or smaller.
1. Only essential investigations should be taken in the case
of pregnant or suspected pregnant women. 6. For systems with multiple AEC sensors, the AEC
sensor(s) covering the area of diagnostic interest should be
2. When radiological examinations of the pelvic area or
selected.
abdomen are required, the exposure must be kept to the
absolute minimum necessary and full use must be made 7. The X-ray beam should not be directed toward the gonads
of gonadal shielding and other protective shielding if unless it is absolutely essential, in which case gonads shields
the clinical objectives of the examination will not be must be used whenever the value of the examination is not
compromised. impaired by such use. Guidelines on the use of gonad shield-
ing are given in section A3.4 of this Code.
3. If a radiological examination of the foetus is required,
the prone position should be used. This has the effect 8. Shielding must be used where appropriate and practicable
of shielding the foetus from the softer X-rays and hence to limit the exposure of body tissues. It is particularly
reducing the foetal dose. important that special effort be made to protect the blood
forming organs, gonads and thyroid of children.
4. Radiography of the chest, extremities, etc., of a pregnant
woman, for valid clinical reasons, should only be carried out 9. The focal spot-to-skin distance should be as large as
using a well-collimated X-ray beam and with proper regard possible, consistent with good radiographic technique.
for shielding of the abdominal area. 10. Radiological examinations of infants and children should
only be performed using techniques and loading factors which
have been modified for size and age.

Safety Code 35 13
11. For very young children, special devices should be 3.3.3 Requirements and Recommendations for
employed to restrict movement. Radioscopic Procedures
12. Full details of the radiological procedures carried out 1. In view of the relatively high exposure that results from
should be noted on the patient’s clinical records. radioscopy, such procedures should only be carried out when
13. All images captured , whether on film or on digital imag- an equivalent result cannot be obtained from radiography.
ing systems, must remain with the patient study unless they Radioscopy must not be used as a substitute for radiography.
are rejected by the operator for valid predefined quality issues. 2. Equipment operators must be trained in radioscopic
All rejected images must be collected for use during routine procedures before carrying out radioscopy on patients. Train-
rejection analysis. The facility must have a program estab- ing must meet with pertinent provincial/regional regulations.
lished to prevent the total loss of any images without review for Continuing professional development must meet with the
reject analysis. requirements of the Maintenance of Certification Program of
the Royal College of Physicians and Surgeons of Canada.
3.3.2 Requirements and Recommendations for (CAR 2005).
Radiographic Procedures
3. Where included in the scope of practice of technologists,
1. The edges of the X-ray beam should be seen on all X-ray a technologist who has been properly trained in radioscopic
images to ensure that no more than the desired area has been procedures can perform radioscopy on patients. It is recom-
irradiated. The image receptor size used should be as small as mended to consult provincial or territorial statutes and regula-
possible, consistent with the objectives of the examination. tions governing the scope of practice of medical technologists.
2. For film-based imaging, the most sensitive screen-film 4. All radioscopic procedures should be carried out as
combination, consistent with diagnostically-acceptable results, rapidly as possible with the smallest practical X-ray field sizes.
should be used. 5. When operating equipment with automatic brightness
3. To ensure that patient exposure is kept to a minimum, control, the operator must monitor the X-ray tube current and
consistent with image quality, full advantage should be taken voltage since both can rise to high values without the knowl-
of a combination of techniques, such as: edge of the operator, particularly if the gain of the intensifier
i) use of an anti-scatter grid or air gap between the is decreased.
patient and the image receptor; 6. When performing radioscopy, the operator must at all
ii) use of the optimum focal spot-to-image receptor times, have a clear line of sight to the output display.
distance appropriate to the examination; 7. Mobile radioscopic equipment should only be used for
iii) use of the highest X-ray tube voltage which pro- examinations where it is impractical to transfer patients to a
duces images of good quality; permanent radioscopic installation.
iv) use of automatic exposure control devices designed 8. Cinefluorography produces the highest patient doses in
to keep all irradiations and repeat irradiations to a diagnostic radiography because the X-ray tube voltage and
minimum. current used are generally higher than those used in radio-
scopy. Therefore, this technique should not be used unless
4. The operator of the X-ray equipment should evaluate significant medical benefit is expected.
the resulting images to verify that the techniques being used
are producing diagnostic quality images and that the X-ray 3.3.4 Requirements and Recommendations for
equipment is functioning correctly. Angiography
5. To avoid the necessity of retakes, it is particularly impor-
tant before taking a long series of images that a single 1. Exposure to the patient’s eyes and thyroid can result
preliminary image of the series should be taken to verify during neurological examinations, such as cerebral angiogra-
correctness of settings. phy and cardiac catheterization and angiography. The tech-
nique of the procedure should take into consideration the risk
to the eyes and thyroid. Where it does not interfere with the
diagnostic information sought, appropriate shielding should
be used.
2. To reduce doses to patient, keep irradiation time to a
minimum.
3. If possible, use an increased tube filtration to reduce low
energy X-rays, and use a lower time frequency in pulse
radioscopy.

14 Safety Code 35
4. Keep the X-ray tube as far as possible and the image should be taken to further restrict the beam to the
intensifier as close as possible from the patient. region of the patient’s body that is of diagnostic interest. Irra-
5. In children and for small adults, the removal of the grid diation of any part of the body outside that region
will reduce doses to patients. contributes nothing to the objective of the examination and
only increases the dose to the body. Irradiation of
6. Be aware that magnification mode may increase the dose gonads, female breast tissue, and the thyroid should be
to the patient. avoided, if possible.
7. Use cine-run only as long as necessary, and if possible, 2. Examinations of children and adolescents. X-ray exami-
use automated injection systems. nations of young children and adolescents whose body
8. If the procedure is long, reposition the tube so that the tissues are developing should not be performed unless a
same area of skin is not subjected to X-ray beam. condition exists such that the benefit of the diagnostic
9. Facilities should have documented, for each type of information outweighs the radiation risk.
interventional procedure, a statement on the radiographic 3. Gonad Shields. Appropriate use of specific area gonad
images (projections, number and loading factors), radioscopy shielding is strongly advised when:
time, air kerma rates and resulting cumulative skin doses and i) the gonads lie within, or are in close proximity to,
skin sites associated with the various part of the interventional the X-ray beam;
procedure.
ii) the patient is of reproductive age; and
3.3.5 Requirements and Recommendations for iii) clinical objectives will not be compromised.
Computed Tomography Procedures 4. Appropriate selection of loading factors and technique.
1. The number of slices produced and the overlap between An appropriate selection of tube voltage, current and filtration
adjacent scans should be kept to the minimum practicable, is particularly important for diagnostic procedures in which
consistent with clinical objectives of the examination. the gonads or breast tissues lie within or near the X-ray beam.
For example, in radioscopy, use of higher tube voltage and
filtration and lower tube current will almost always reduce
the gonad dose.
3.4 Guidelines for Reduction of
Dose to Sensitive Tissues 5. Sensitivity of imaging system. Doses are related to the
sensitivity of the imaging system. Thus, an increase in the sen-
Ionizing radiation has the ability to produce gene mutations sitivity of the imaging system reduces the dose; conversely,
and chromosome aberrations in cells. These effects are decreasing the sensitivity increases the dose. It is therefore,
especially important in two circumstances, exposures to re- very important to maintain the sensitivity of the imaging
productive cells, and rapidly dividing cells. When such effects system at its optimum value and to be alert for any significant
occur in a reproductive cell(gametes and the stem cells they deterioration.
arise from), undesirable mutations may be transmitted to sub-
sequent generations. If damage is caused in rapidly dividing
cells mutations will rapidly be passed on to the cell progeny, 3.5 Diagnostic Reference Levels (DRLs)
amplifying the deleterious radiation effects.
3.5.1 Introduction
Medical X-ray exposures are, at present, the major contributor Doses for medical diagnostic procedures can vary widely
of gonadal radiation exposure to the population. By reducing between equipment and facilities. Numerous surveys have
the gonadal dose to individual patients one can, in fact, make demonstrated that, for typical procedures, the difference in
a significant contribution toward the reduction of the geneti- radiation doses can be as wide as a factor of 50 to 100. For
cally significant dose to the population. It is generally pre- interventional procedures, this difference can be even wider. In
sumed that there is no threshold dose below which genetic diagnostic radiology, the use of surface air kerma limits is not
effects cannot occur. Therefore, it is important that even small sufficient since these dose limits are usually set at a level high
radiation exposures to the sensitive tissues of patients be enough so that any doses greater than the limit is clearly un-
avoided, unless such exposures can be shown to be medically acceptable, but this limit does not help in optimising patient
necessary. doses. For this reason, the concept of Diagnostic Reference
Levels (DRLs) is introduced, instead of using maximum dose
Individuals performing X-ray examinations of patients must limits.
pay special attention to the following factors that are important
for reducing doses to sensitive organs: The purpose of DRLs is to promote a better control of patient
1. Correct collimation of the X-ray beam. It is not sufficient exposures to X-rays. This control must be related to the
merely to limit the beam to the size of the image receptor. Care clinical purpose of the examination. DRLs must not be seen

Safety Code 35 15
as limits but instead as guidance to optimise doses during meters, or through information retrieved from the Radiology
procedures. DRLs are based on typical examinations of stan- Information System (RIS) , or other means. The use of DAP is
dardized patient or phantom sizes, and for a broad type of more practical since the whole procedure is recorded and their
equipment. While it is expected that facilities should be able to use is less complicated than TLDs, while with the use of RIS,
attain these levels when performing procedures using good the patient weight may not be available.
methodologies, it is not expected that all patients should
receive these dose levels but that the average of the patient The values presented in section A3.5.3 are provided to facili-
population should. DRLs are useful where a large reduction ties for guidance. The values presented are dependent of
in patient doses may be achieved, such as for computed patient size and, as such, a facility will need to evaluate
tomography (CT) procedures, where a large reduction in whether their patient population falls within the range of
collective doses may be achieved, such as for chest X-rays, or patient size for the procedure. While this safety code recom-
where a dose reduction will result in a large reduction in risk, mends representative DRLs, a hospital or clinic can set their
such as for paediatric procedures. However, interventional own local DRLs if enough data is available. The facility should
procedures are not going to be addressed at this time since it create a list of reference doses for their patient population and
is difficult to establish DRLs for them due to the variability in use these values within their quality assurance program. DRL
techniques, the frequency of procedures, the difficulty in dose values should be reviewed from time to time to assess their
measurement, and the lack of published data. appropriateness. It is recommended that this review be done
annually.
3.5.2 Application
The tables shown in section A3.5.3, list representative ranges Radiological facilities which fall under provincial or territo-
of DRLs for radiographic procedures, performed on adults rial jurisdiction should contact the responsible agency in their
and children, radioscopic procedures and CT procedures. It is respective region for information on any provincial or territo-
obvious that not all facilities will perform all of the listed pro- rial statutory or regulatory requirements concerning dose
cedures. Therefore, each facility should establish DRLs for limits. A listing of these responsible agencies is provided in
those procedures relevant to them and where the number Appendix V.
of patients undergoing the procedures is sufficiently high.
A facility may set DRLs for other procedures not presented DRL values must not be used for comparison with individual
in the tables but which are being performed. At least one patients. The values should be compared only with the average
procedure should be evaluated for each X-ray equipment. of a collection of patients of a specific weight. The evaluation
of conformity with DRLs should be done at the X-ray room
DRL measurements can be performed in two different ways; level or X-ray equipment type, i.e., mobiles, CT. For each
with a phantom specifically designed for the procedure, or examination under consideration, the mean patient doses for
using patients. In general, it is preferable to use phantoms since each room should be compared to the DRL for the examina-
the measurements can be more easily replicated and offer more tion. If the mean dose is found to significantly and consistently
flexibility in the type of procedures which can be performed. exceed the suggested DRL, an investigation of the perform-
Appropriate phantom, such as phantoms for chest, lumbar ance of the equipment, the radiological technique used, and
spine and abdomen representing a patient thickness, in the PA the methodology of dose measurement should be done in order
projection, of 23 cm are acceptable for DRL measurements, to reduce patient doses. It is recommended that this action
as long as they are consistently used. DRLs for CT are based level be set at a defined proportion (i.e., 25% of the mean)
on the weighted CT Dose Index, or CTDIw which can be and at least twice the standard error of the mean of the
determined by using CT Dosimetry Phantoms, described in measurements.
Table 22, section C3.6.3.
3.5.3 Recommended DRL Values
When patients are be used to establish DRLs, measurements Table 1 presents representative DRL values for radiographic
should be done only on patients whose individual weight is procedures performed on adults. Table 2 presents DRL values
70 ± 20 kg, and the average weight measurement of the for a 5 year old child along with the mean body thicknesses for
patients should be 70 ± 5 kg. It is recommended that the each examination. It should be noted that the range of values
minimum sample size for a specific procedures or equipment provided for the entrance surface dose is reflective of the
be 10 patients. Patients should not be used for paediatric variation of values found in published data. Representative
procedures. DRLs for radioscopic and CT examinations are shown in
Table 3 and Table 4 respectively.
Entrance surface doses for establishing DRLs can be meas-
ured using thermoluminescent dosimeters (TLDs) placed on
the tube side of the patient, by using dose area product (DAP)

16 Safety Code 35
Table 1: Representative DRLs for radiographic procedures Table 3: Representative DRLs for radiographic procedures
performed on adults (IPEM 2004), (IAEA 1996) (IPEM 2004)

Entrance Surface Dose Dose Area Product

Examination Examination
(mGy) (Gycm2)
Chest (PA) 0.2 - 0.3 Abdominal Radioscopy 20 - 70

Chest (LAT) 0.7 - 1.5 Barium Enema 30 - 60

Thoracic Spine (AP) 5-8 Coronary Angiography 35 - 75

Thoracic Spine (LAT) 7 - 10

Lumbar Spine (AP) 7 - 10 Table 4: Representative DRLs for CT procedures

(IPEM 2004), (Aldridge 2006), ( Shrimpton 2004)
Lumbar Spine (LAT) 15 - 30
Dose
Abdomen (AP) 7 - 15 CTDIw
Examination Length Product
(mGy)
(mGycm)
Pelvis (AP) 5 - 10
Head 60 930 - 1300
Skull (AP) 4-5
Face and Sinuses 35 360
Skull (LAT) 2-3
Chest 30 580 - 650

Abdomen - Pelvis 35 560 - 1100

Table 2: Representative DRLs for radiographic procedures
performed on a five-year-old child (IPEM 2004) Liver and Spleen 35 470 - 920

Mean Body Entrance

Examination Thickness Surface Dose
(cm) (Hart et al.) (mGy)

Chest (AP/PA) 13.4 0.05 - 0.15

Chest (LAT) 18.8 0.15 - 0.25

Abdomen (AP/PA) 13.6 0.5 - 1.0

Pelvis (AP/PA) 13.7 0.6 - 1.0

Skull (AP) 17.8 1.0 - 2.0

Skull (LAT) 13.8 0.8 - 1.5

Safety Code 35 17
Section B:
Facility and Equipment Requirements
1.2.1 Preparation of Facility Plan
In order to determine the shielding requirements for an X-ray
1.0 Facility Requirements facility a floor plan must be prepared, clearly identifying the
following components:
1.1 General Criteria
1. The dimensions and shape of the room where the X-ray
In the planning of any medical X-ray facility the main prior- equipment is operated and the physical orientation of the room
ity is to ensure that persons in the vicinity of the facility are not (a mark indicating North).
exposed to levels of radiations which surpass the current 2. The location where the X-ray equipment is planned to be
regulatory exposure limits. Appropriate steps must be taken placed and the range of movement of the X-ray tubes.
to ensure adequate shielding is present to meet the following
3. The location of the control booth, if applicable.
requirements:
4. The location, use, occupancy level and accessibility of
1. the radiation levels in controlled areas that are occupied
adjacent rooms, as well as rooms above and below the
routinely by radiation workers must be such that no radiation
facility.
worker is occupationally exposed to more than
20 mSv per year; and 5. The designation of the adjacent rooms, whether to be
designated as a controlled or uncontrolled area. Controlled
2. the radiation levels in uncontrolled areas must be such that
areas, mainly occupied by radiation workers, are subject to the
no person receives more than 1mSv per year.
limit of 20 mSv per year, whereas uncontrolled areas, mainly
occupied by non-radiation workers, are subject to the limit
Appendix I provides a detailed description of the regulatory
of 1 mSv per year. In uncontrolled areas, where radiation
dose limits. For medical X-ray imaging facilities, controlled
sensitive populations are present, such as paediatric wards, a
areas are typically in the immediate areas where X-ray equip-
constraint level of 0.30 mSv per year should be used.
ment is used such as the procedure room and X-ray control
booths. The workers in these areas are primarily equipment 6. The location where image processing is performed,
operators such as radiologists and radiation technologists who i.e., location of darkrooms, film storage area, computer work-
are trained in the proper use of the equipment and in radiation stations.
protection. Uncontrolled areas are those occupied by individ- 7. The position of all windows, doors, louvers, etc., that may
uals such as patients, visitors to the facility, and employees affect radiation protection requirements.
who do not work routinely with or around radiation sources 8. The planned and existing materials used to construct the
(NCRP 2004). walls, floor, ceiling, and the control booth, and their thick-
nesses including additional materials currently being used, or
In general, attention to the basic principles of distance, time planned for use, as radiation shielding barriers.
and shielding are required to determine shielding needs.
9. The application of the protective barriers. Will the inter-
vening shield between the X-ray tube and the occupied area
act as a primary or as a secondary protective barrier, i.e., will
1.2 Design and Plan of X-ray Facility
the barrier be required to attenuate the direct X-ray beam or
In the early stages of designing and planning a medical X-ray stray radiation only?
facility, three steps should be taken to ensure adequate
shielding is in place to provide the necessary level of radiation
protection:
A. preparation of facility plans;
B. considerations for room design and layout;
C. determination of parameters governing shielding
requirements.

18 Safety Code 35
1.2.2 Considerations for Room Design and Layout 1.2.3 Determination of Parameters Governing
When designing the layout of the X-ray facility, the following Structural Shielding Requirements
general recommendations must be considered. The thickness of the shielding material, such as lead, concrete,
1. Radiology rooms, with stationary X-ray equipment, or gypsum wallboard, required to reduce radiation levels to the
which can be accessed from public areas should be equipped recommended dose limits can be determined through calcula-
with a self-closing door, and must be identified with warning tions. In general, the radiation exposure to individuals depends
signs incorporating the X-ray warning symbol and the words primarily on the amount of radiation produced by the source,
“Unauthorized Entry Prohibited”. Acceptable forms of the the distance between the exposed person and the source of the
X- ray warning symbol are given in Appendix VI, Radiation radiation, the amount of time that an individual spends in the
Emitting Devices Regulations for Diagnostic X-ray irradiated area, and the amount of protective shielding between
Equipment. the individual and the radiation source.
2. Mobile X-ray equipment used routinely in one location The parameters listed below must be considered for the cal-
must be considered as a fixed installation and the shielding culation of barrier thicknesses. Allowance should be made for
needs for the equipment and room must be determined possible future changes in anyone or all of these parameters,
accordingly. including increases in use and occupancy factors, in operating
3. The rooms containing the X-ray equipment should be tube voltage and workload, as well as modifications in tech-
designed to provide adequate working space to the equipment niques that may require ancillary equipment.
operator and to allow for ease of patient movement.
4. The X-ray equipment should be positioned in the room 1. The maximum X-ray Workload, (W) or the workload
in such a way that, during an irradiation, no one can distribution.
enter the room without the knowledge of the equipment The workload is a measure of the operational time or
operator. the amount of use of the X-ray equipment. A workload distri-
5. The X-ray beam must always be directed toward bution indicates the workload across a range of operating
adequately shielded areas. Particular attention must be paid voltages. The workload and workload spectrum can be deter-
to the adequacy of shielding for chest radiography using wall- mined by recording the operating voltage and current-time
mounted image receptors. product of each irradiation taken in each X-ray suite over a set
6. Whenever possible, the X-ray beam and scattered radia- period of time (i.e., week). For irradiations made under Auto-
tion must be absorbed as close as possible to the patient or matic Exposure Control, the operating voltage, procedure type
scatterer. and patient thickness should be recorded to be used later to
estimate the current-time product. If actual workload values
7. A control booth must be provided for the protection of the
are not available, Table 5 presents estimated total workloads
operator, if applicable, for the type of equipment. The control
for various medical X-ray facilities (NCRP 2004).
booth, and the viewing window, must have shielding proper-
ties such that no operator is occupationally exposed to more
than 0.4 mSv/week. The ALARA principle requires that addi-
tional shielding be specified in the design to further reduce op-
erator exposure, wherever this can reasonably be done. Mobile
protective screens must not be considered adequate as a con-
trol booth for radiological procedures.
8. The control booth should be located in an area, whenever
possible, such that the radiation has to be scattered at least
twice before entering the booth.
9. Shielding must be constructed to form an unbroken barrier
and if lead is used, it should be adequately supported to prevent
“creeping”.

Safety Code 35 19
Table 5: Typical Workloads (NCRP 2004)

Typical Number of Patients Total Workload per week

Total Workload
(per 40 hour week) (mA min/week)
per patient
(mA min/patient) Average Busy Average Busy

Radiographic Room (chest) 0.6 120 160 75 100

Radiographic Room (other) 1.9 120 160 240 320

Dedicated Chest Room 0.22 200 400 50 100

R and F Room
a 13 20 30 260 400
(radioscopic system)
R and Fa Room 1.5 25 40 40 40
(radiographic system)
Angiography Room 160 20 30 3,200 4,800
(cardiac)
Angiography Room 64 20 30 1,300 2,000
(other vascular)

a. R and F is a room that contains equipment for both radiography and radioscopy (fluoroscopy).

2. The occupancy factor (T) 3. The use factor (U)

The Occupancy factor is the fraction of time that the The use factor, is the fraction of the workload during
area under consideration is occupied by the individual which the X-ray beam is pointed in the direction under
(employee or public) who spends the most time at that consideration. The following table present recommended
location while the X-ray equipment is operating. The occupancy factors.
following table present recommended occupancy factors.

Table 7: Use Factor for Primary Barrier

Table 6: Occupancy Factors
Primary Barrier
T=1 Administrative offices and receptionist areas, U=1 Floors of radiation rooms, walls containing a vertical
laboratories, pharmacies and other areas fully occupied image receptor; any other walls, doors or ceiling areas
by an individual, attended waiting rooms, children’s routinely exposed to the direct radiation beam.
indoor play areas, adjacent X-ray rooms, image viewing
areas, nurses’ stations, X-ray control rooms, living U=1/4 Doors and wall areas of radiation rooms not routinely
quarters. exposed to the direct radiation beam.
T=1/2 Rooms used for patient examinations and treatments. U= 1/16 Ceiling areas of radiation rooms not routinely exposed
to the direct radiation beam.
T=1/5 Corridors, patient rooms, staff lounges, staff rest rooms.
Secondary barrier
T=1/8 Corridor doors.
U=1 The use factor for secondary protective barriers is
T=1/20 Public toilets, unattended vending areas, storage rooms, always taken to be 1.
outdoor areas with seating, unattended waiting rooms,
patient holding areas.
T=1/40 Outdoor areas with only transient pedestrian or vehicular
traffic, unattended parking lots, vehicular drop off areas
(unattended), attics, stairways, unattended elevators,
janitor’s closets.

20 Safety Code 35
1.3 Shielding Calculations 1.3.1 Radiographic Films
Film storage containers must be adequately shielded to ensure
Shielding calculations must be made for both primary and sec-
that excessive exposure of film by X- rays does not occur.
ondary protective barriers. Primary protective barriers provide
Sufficient film shielding must be in place to reduce the
shielding from the direct X-ray beam and therefore must be
radiation level to stored film to less than 0.1 mGy over
placed in such an orientation as to intersect the X-ray beam.
the storage period of the film. The values presented in
Secondary protective barriers are required to provide shielding
Appendix IV are very conservative but will protect films from
from scattered and leakage X-rays.
radiation exposure for most circumstances. Once films are
loaded into cassettes, radiation exposure levels should be less
Comprehensive shielding calculations for large radiological
than 0.5 µGy and the resulting increase in the base-plus-fog
facilities should only be performed by individuals with current
should be less than 0.05 O.D. Refer to Appendix IV for
knowledge of structural shielding design and the acceptable
storage guides for radiographic film.
methods of performing these calculations. It is recommended
that shielding calculations be performed using the methodol-
1.3.2 Radiographic X-Ray Equipment and
ogy presented in the National Council on Radiation Protection
Dedicated Chest Radiographic Equipment
and Measurements (NCRP) Report No. 147: Structural Shield-
ing Design for Medical X-Ray Imaging Facilities (NCRP Primary and secondary shielding must be provided for
2004). However, it must be noted that the shielding design radiographic equipment where the tube can be manipulated in
goals specified in NCRP Report 147 are not adopted in this several directions. The walls and floor where the X-ray tube
Safety Code. The shielding design goal values may be lower can be directed are considered primary barriers whereas the
but must not exceed the limits set out in section B1.1 for other walls and ceiling are secondary barriers. The primary
controlled and uncontrolled areas. Due to the extensiveness of barrier includes the wall behind the vertical image receptor, or
the information, the methodology of NCRP 147, including “wall or chest bucky”, and the floor under the radiographic
equations, tables and figures, is not provided in this Safety table. For dedicated chest radiographic equipment, the wall
Code. Alternatively, the methodology presented in NCRP behind the image receptor is considered a primary barrier.
Report No. 49 (NCRP 1976) is also acceptable and presented
in Appendix III. The X-ray tube should never be directed towards the control
booth. Therefore the walls of the control booth are calculated
Under the methodology used in NCRP Report 147, the as secondary barriers. The information required for calcula-
following are assumptions made in the shielding calculation: tion of the shielding of radiographic X-ray equipment and
dedicated chest radiographic equipment is found in Table AII.1
 The attenuation of the radiation beam by the
of Appendix II.
patient is neglected.
 The incidence of the radiation beam is always 1.3.3 Radioscopic X-Ray Equipment and
perpendicular to the barrier being evaluated. Angiographic X-Ray Equipment
 The calculation does not take into account the The design of radioscopic X-ray equipment is such that only
presence of materials in the path of the radiation secondary shielding must be provided for these types of
other than the specified shielding material. systems. However, in systems where an X-ray tube for radi-
 The leakage radiation from the X-ray equipment is ography is also present, the shielding for this X-ray tube must
assumed to be an air kerma of 0.876 mGy h-1. be evaluated independently, as in Section B1.3.2. When equip-
ment include more than one X-ray tube, such as in cardiac
 The minimum distance to the occupied area from a
systems, the shielding calculation must take into account
shielded wall is assumed to be 0.3 m.
each X-ray tube independently. The information required for
calculation of the shielding of radioscopic X-ray equipment is
The information outlined in sections B1.1 and B1.2 along found in Table AII.2 of Appendix II.
with the final plans of the installation must be submitted for
reviewed by the appropriate responsible government agency. 1.3.4 Computed Tomography Equipment
For installations under federal jurisdiction, the responsible
The design of computer tomography equipment is such that
agency is the Consumer and Clinical Radiation Protection
only secondary shielding must be provided. The calculation of
Bureau, Health Canada, Ottawa, Ontario K1A 1C1. Radio-
shielding for CT rooms should not rely on workload values as
logical facilities that fall under provincial or territorial
defined in Section B1.2.3 and therefore it is recommended that
jurisdiction should contact the responsible agency in their
shielding requirements be calculated using the methodology
respective province or territory listed in Appendix V.
of NCRP 147 for CT equipment. The information required
for calculation of the shielding of CT equipment is found in
Table AII.3 of Appendix II.

Safety Code 35 21
 whether the staff of the facility possesses the expertise to
use the equipment, whether adequate space is available for
2.0 Medical X-ray installation of the new equipment, and the date on which the
equipment must be installed and operational at the facility. All
Equipment Requirements staff members who will be routinely using the equipment
should be consulted for input at this stage.
2.1 Regulatory Requirements for
Medical X-ray Equipment 2.2.2 Equipment Specifications
All new, used, and refurbished medical X-ray equipment, and Equipment specifications must be prepared with full knowl-
accessories for such equipment, which are sold, imported or edge of the clinical needs and operational conditions, as well
distributed in Canada, must conform to the requirements of as manufacturer’s specifications, and regulatory requirements.
the Radiation Emitting Devices Act, the Food and Drugs Act Equipment specifications supplied to the vendor should iden-
and their promulgated regulations. These are the Radiation tify the type of X-ray equipment needed and the types of
Emitting Devices Regulations and the Medical Devices Reg- clinical procedures intended to be performed with the equip-
ulations. The Radiation Emitting Devices Regulations specify ment. It should also identify all system components and
standards for information, labelling, construction and per- provide a complete description of the design, construction and
formance of equipment, with respect to radiation safety. The performance features of each component. The level of per-
Medical Devices Regulations encompass all other safety formance should be such that most manufacturers should be
considerations and the question of efficacy for all medical able to meet these performance requirements with readily
X-ray equipment sold in Canada. It is the responsibility of the available components and product lines. All relevant require-
manufacturer or distributor to ensure that the equipment ments stated in this Safety Code and any further requirements
conforms to the requirements of these regulations. In addition, as specified by the agency responsible for the facility should
X-ray equipment must meet any applicable requirements under also be addressed in the equipment specifications. Any elec-
provincial or territorial jurisdictions for such equipment. trical, mechanical and environmental conditions which may
The Canadian Standards Association and provincial electrical affect the performance of the equipment should also be
utility should be consulted for further information. included.

Part XII of the Radiation Emitting Devices Regulations The equipment specifications should also include other rele-
addressing medical X-ray equipment, in effect at the time of vant information such as the details concerning the equipment
publication of this Safety Code, is reproduced in Appendix VI. installation and calibration by the vendor and the associated
These regulations may be amended from time to time, to keep deadlines, the type of warranty and service plan needed, and
up-to-date with changing technology in the field. Information whether training of staff is required from the manufacturer. In
on the applicability and currency of the Radiation Emitting general, the equipment specifications must identity all criteria
Devices Regulations may be obtained by contacting the which must be met for acceptance of the equipment.
Consumer and Clinical Radiation Protection Bureau, Health
Canada, Ottawa, Ontario K1A 1C1. Testing equipment required to perform daily to monthly qual-
ity control procedures, which are not already available, must
be purchased at the same time as the X-ray unit.
2.2 Equipment Purchasing
2.2.3 Analysis of Vendor Quotation and
The purchase of medical imaging equipment is one of the most the Purchase Contract
significant expenditures of an imaging facility. It is therefore
Vendor quotations must be thoroughly reviewed to ensure
essential to ensure that the desired design and level of per-
that the vendor supplied equipment specifications address the
formance are being obtained in a cost-effective manner. Below
identified needs of the facility. The vendor’s quotation should
is an outline of the recommended process for purchasing
include the installation and calibration of the equipment,
medical imaging equipment.
warrantees, delivery time, maintenance plans, quality control
testing equipment, staff training and all other criteria included
2.2.1 Needs Analysis
in the purchasers equipment specifications.
A needs analysis must be performed to identify the type
and specifications of equipment required to meet the clinical The purchase contract should set out all items and conditions
X-ray imaging needs. When performing a needs analysis, the of the purchase specified in the equipment specifications and
main points which should be considered are the types of vendor’s quotation which have been agreed upon by the
investigations that the facility intends to perform with the purchaser and vendor. All conditions for acceptance of the
equipment, and the level of performance needed from the equipment must be clearly specified, as well as, action to be
equipment. Other points which should to be addressed are

22 Safety Code 35
taken if conditions for acceptance are not met. A detailed and has been specified in the Regulations applicable to the class
concise purchase contract will ensure the delivery of equip- of X-ray equipment, must comply with the standards in effect
ment in a timely and cost-effective manner. at the time of replacement.

2.2.4 Acceptance Testing

Acceptance testing must be performed prior to any clinical use 2.4 Retrofitting with Computed
of the equipment. Acceptance testing is a process to verify Radiography (CR) and
compliance with the performance specifications of the X-ray Digital Radiography (DR) Systems
equipment as written in the purchase contract. It must also
verify that the equipment performance meets the manufac- When purchasing a CR system for a new or existing X-ray
turer’s specifications and complies with federal and provincial system or an after market DR detector to be installed on an
or territorial regulations. It is recommended that acceptance existing system, both CR and DR systems must meet the
testing be performed by, or under the supervision of, a medical requirements of the Radiation Emitting Devices Act and Reg-
physicist, with in-depth knowledge of the particular type of ulations, as well as the Food and Drugs Act and the Medical
X-ray equipment and the relevant regulations. This individual Devices Regulations. Furthermore, the existing X-ray system,
must be independent of the manufacturer. onto which the CR or DR systems is fitted, must meet the
current requirements of Part XII of the Radiation Emitting
Acceptance testing of a medical X-ray system includes Devices Regulations. CR and DR image receptors must only
several major steps. They are: be installed on X-ray systems which have an automatic means
1. the verification that delivered components or systems of controlling exposures, such as an automatic exposure con-
correspond to what was ordered; trol. The system must be calibrated to reflect the sensitivity of
the digital receptor. Part XII of the Radiation Emitting Devices
2. the verification of the system mechanical integrity and Regulations, in effect at the time of publication of this Safety
stability, including safety mechanisms, automatic patient Code, is presented in Appendix VI. For radiography, it is
release, power drives, interlocks; recommended that the detector pitch be equal or better than
3. the verification of electrical installation, including elec- 200 µm, and the system radiation sensitivity should be greater
trical safety, power line fluctuation; than an equivalent 200 speed film screen system for equiva-
4. the verification of X-ray performance; and lent diagnostic images.
5. the verification of imaging or diagnostic performance.

More detailed information on acceptance testing of radi-

2.5 Equipment Specific Requirements
ographic, radioscopic and CT equipment is available in publi- Construction and performance requirements are listed below
cations from the International Electrotechnical Commission for radiographic, radioscopic and CT equipment. The Radia-
(IEC 1999), (IEC 2004). tion Emitting Devices Regulations, Part XII (Diagnostic
X-ray Equipment) should be referred to for more detailed
X-ray performance tests performed during the acceptance information on each requirement including, for some require-
testing should also reflect the requirements described in sub- ments, measurement conditions and methodologies.
section B2.5. The results from the acceptance testing should be
used to establish baseline values and limits of acceptance on 2.5.1 General Requirements
operational performance of the X-ray equipment. These base-
The following requirements must be met by all radiographic,
line values and limits are essential to the quality assurance
radioscopic, and CT equipment. It is important to note that
program.
these requirements are reflective of the requirements of
Part XII, Diagnostic X-ray Equipment, Radiation Emitting
Devices Regulations, effective at the time of publication of this
2.3 Existing Medical X-ray Equipment Safety Code. Therefore any future amendments to the regula-
Whenever possible, existing medical X-ray equipment should tions may also affect the requirements of this section.
be upgraded to incorporate as many as possible of the safety 1. Warning Signs—The X-ray control panel must bear a
and performance features required of new medical X-ray permanent, visible and legible sign warning that hazardous
equipment, as specified in the Radiation Emitting Devices X-rays are emitted when the equipment is in operation and
Regulations in effect at that time. It should be noted that it is prohibit unauthorized use.
a requirement of the Radiation Emitting Devices Act that re- 2. Markings—All controls, meters, lights and other indica-
placements for any component or subassembly of an X-ray tors relevant to the operation of the equipment must be read-
machine, for which a construction or performance standard ily discernible and clearly labelled or marked as to function.

Safety Code 35 23
3. Mechanical Stability—The X-ray tube must be securely to the maximum specified energy input in one hour and,
fixed and correctly aligned within the X-ray tube housing. In when the equipment is not in the loading state, 20 µGy/h at a
the case of CT equipment, the X-ray tube housing must be distance of 5 cm from any accessible surface.
securely fixed and correctly aligned within the CT gantry. The 9. X-ray Beam Filtration—There must be radiation-absorbing
X-ray source assembly and patient support must maintain their filters that provide a degree of attenuation such that the first
required positions without excessive drift or vibration during Half-Value Layer (HVL) of aluminum is not less than the
operation. values shown in Table 8 for a selected X-ray tube
4. Indicator Lights—There must be readily discernible, voltage. For other X-ray tube voltages, the HVL of the
separate indicators on the control panel that indicate: radiation beam must be calculated by linear interpolation from
i) when the control panel is energized and the that Table. This requirement applies only to radiographic and
machine is ready to produce X-rays; radioscopic equipment. For CT equipment see item 5 in
section B2.5.4 below.
ii) when X-rays are being produced;
iii) if an automatic exposure control is provided, when Table 8: Minimum Half-Value Layers of aluminum
for given X-ray tube voltages (IEC 2008)
that mode of operation is selected;
X-ray Tube Voltage Half-Value Layer of Aluminum
iv) if an automatic exposure control mode is not (kV) (mm)
selected or does not exist, the selected loading
70 2.5
factors to the operator before an irradiation; and
80 2.9
v) if the equipment is battery powered, whether the
battery is adequately charged for proper operation 90 3.2
of the equipment. 100 3.6

5. Indication of Loading Factors—Medical X-ray equipment 110 3.9

having adjustable loading factors must incorporate meters or 120 4.3
other indicators on the control panel that enable determination 130 4.7
of the X-ray tube voltage, X-ray tube current and time, or
140 5.0
combinations of these. For equipment having non-adjustable
loading factors, permanent marks or labels may be used to in- 150 5.4
dicate these parameters. The loading factors must be displayed
before, during and after the irradiation is complete. 2.5.2 Radiographic Equipment Requirements
6. Irradiation Control—There must be an irradiation switch,
1. Radiation Output Reproducibility—For any combination
controlling timer or other mechanism to initiate and
of operating loading factors, the coefficient of variation of
terminate X-ray production.
any ten consecutive radiation irradiation measurements, taken
7. Controlling Timer—When the equipment is equipped at the same source to detector distance within a time period
with a controlling timer it must be constructed so that of one hour, is no greater than 0.05, and each of the ten irradi-
i) it can automatically terminate an irradiation on ation measurements is 15% of the mean value of the ten
completion of a preset irradiation time, on attain- measurements.
ment of a preset current time product value, or on The coefficient of variation is the ratio of the standard
completion of a preset number of X-ray pulses, deviation to the mean value of a series of measurements
ii) it permits the operator to terminate an irradiation calculated by using the following equation:
at any time,
1/ 2
⎡ n 2 ⎤
iii) it automatically resets itself to its original setting
or to zero on termination of an irradiation, and S ⎢ ∑
1 i=1
( Xi − X ) ⎥
iv) when it is at zero, at the off position or at an C= = ⎢ ⎥
X X⎢ n−1 ⎥
unmarked setting, an irradiation cannot occur. ⎢ ⎥
8. X-ray Tube Shielding—The X-ray tube must be enclosed
⎣ ⎦
in a shielded housing. The shielding of the housing must be where
such that the leakage radiation from the X-ray source assem- C is the coefficient of variation;
bly shall not exceed an air kerma rate of 1.0 mGy/h at a S is the estimated standard deviation;
distance of 1 m away from the focal spot, when operated at Xi is the value of the ith measurement;
the nominal X-ray tube conditions of loading corresponding X is the mean value of the measurements; and
n is the number of measurements.

24 Safety Code 35
2. Radiation Output Linearity—For any preselected value iii) 10% + 1 ms for loading time, and
of X-ray tube voltage, within an applicable range, the iv) 10% + 0.2 mAs for current-time product.
quotient of the average air kerma measurement divided by the
indicated current time product obtained at two applicable set- 7. Minimum Irradiation Time Capability—The controlling
tings must not differ by more than 0.10 times their sum, that is, timer or automatic exposure control device must have a mini-
mum irradiation time capability of 1/60 s or the time required
to deliver a current-time product of 5 mAs, whichever is
X 1 − X 2 ≤ 010
. ( X1 + X 2 ) greater.

where X1 and X2 are quotients of the average air kermas 8. Beam Limiting Devices—The X-ray tube housing must
measurement divided by the current time product at two be equipped with a beam limiting device that enables
applicable settings of X-ray tube current or X-ray tube stepless adjustment of the size of the X-ray field. The
current-time product. minimum X-ray field size permitted by the beam limiting
device shall not exceed 5 cm by 5 cm at a focal spot to image
3. Irradiation Switch—When the equipment is equipped receptor distance of 100 cm.
with an irradiation switch it must require continuous
pressure by the operator to emit X-rays. 9. Radiation Field and Light Field Alignment—The beam
limiting device must incorporate an X-ray field indicator
4. Automatic Exposure Control—For film-based systems, which uses light to visually define the X-ray field so that the
the automatic exposure control device shall perform limits of the X-ray field are visible under the ambient lighting
in such a way that the variation of optical density in the condition in an X-ray room. When the X-ray beam axis is per-
resultant radiograms shall not exceed the value of pendicular to the image receptor plane, the separation between
i) 0.15 when the X-ray tube voltage is variable and the perimeter of the visually defined field and that of the X-ray
the thickness of the irradiated object is constant, field does not exceed 2% of the focal spot to image receptor
ii) 0.20 when the thickness of the irradiated object is distance.
variable and the X-ray tube voltage is constant, 10. Focal Spot Marking—The location of the focal spot must
iii) 0.20 when the thickness of the irradiated object and be clearly and accurately marked on the X-ray tube housing.
the X-ray tube voltage are both variable, and In the case of dual focal spot X-ray tubes, the location of the
mark should be midway between the centres of the two focal
iv) 0.10 when the thickness of the irradiated object and spots.
the X-ray tube voltage are both constant.
For digital systems, the performance of the automatic 2.5.3 Radioscopic Equipment Requirements
exposure control must be assessed according to the
manufacturer’s procedures and must be within the manufac- 1. Accuracy of Loading Factors—The loading factors must
turer’s specifications. It is recommended that the automatic ex- not deviate from the selected value, for any combination of
posure control should perform in such a way that the variation loading factors, by more than
in the mean linearized data on a constant region of interest i) 10% for X-ray tube voltage,
does not exceed 20% for constant X-ray tube voltage and con- ii) 20% for X-ray tube current.
stant thickness of the irradiated object, when the X-ray system
is operated in conditions representative of the typical clinical 2. Visual Indicators—The equipment must have visual
use. Compliance is checked by ensuring that the ratio of the indicators which continuously display the X-ray tube voltage
highest and the lowest measured values is less than or equal to and the X-ray tube current.
1.2 or within the manufacturer’s specifications. 3. Protective Shielding of Image Intensifier—Radioscopic
5. Current-Time Product Limit—There must be a means to equipment must be constructed to include an X-ray image in-
ensure that where the X-ray tube voltage is 50 kV or more, the tensifier that includes protective shielding such that for any
current time product does not exceed 600 mAs per focal spot to image receptor distance, the entire cross section
irradiation. of the X-ray beam is intercepted within the primary protective
shielding. Also, the radioscopic X-ray tube must not be capa-
6. Accuracy of Loading Factors—The loading factors must ble of emitting X-rays unless the protective shielding is in
not deviate from the selected value, for any combination of place to intercept the X-ray beam.
loading factors, by more than
4. Focal Spot-to-Skin Distance—The equipment must be
i) 10% for X-ray tube voltage, equipped with a device that limits the focal spot to skin
ii) 20% for X-ray tube current, distance. The focal spot to skin distance must not be less than
30 cm for mobile equipment, 38 cm for stationary equipment,
20 cm, for radioscopic equipment designed for special appli-
cations that would be impossible at 30 cm or 38 cm. In the
case of small-format, low-intensity radioscopic equipment, the

Safety Code 35 25
minimum focal spot to skin distance is the distance at which 3. Emergency Termination of Motorized Movements and
the equipment is capable of delivering an air kerma rate of Loading—An emergency stop switch must be in place on or
50 mGy/min. near the patient support and/or gantry to immediately termi-
5. Irradiation Switch—The radioscopic irradiation switch nate the motion of the equipment and the emission of X-rays.
must require continuous pressure by the operator for the entire 4. Focal Spot to Skin Distance—The minimum focal spot to
period of any irradiation and enable the operator to terminate skin distance must be at least 15 cm.
the recording of serial radioscopic images at anytime. 5. X-ray Beam Quality—Fixed added filters must be used
6. Chronometer—Radioscopic equipment must be equipped to provide a degree of attenuation such that the first Half-Value
with a chronometer that indicates the amount of time that the Layer (HVL) of aluminum is not less than the values shown in
equipment has been emitting X-rays and can be reset to zero Table 9 for a selected X-ray tube voltage. For intermediate
or any other selected value. X-ray tube voltages, the HVL of the radiation beam must be
7. High-level Irradiation Control—High-level irradiation calculated by linear interpolation from that Table. For X-ray
control must be activated by a separate means that requires tube voltages which are less than 60 kV or greater than
continuous pressure by the operator to emit X-rays. An audi- 140 kV, the HVL of the radiation beam must be calculated by
ble signal must be emitted when the high-level linear extrapolation from that Table.
irradiation control is in use.
Table 9: Minimum Half-Value Layers of aluminum
8. Maximum Air Kerma Rates—The following maximum air for given X-ray tube voltages
kerma rates apply to radioscopic equipment except during X-ray Tube Voltage Half-Value Layer of Aluminum
recording of radioscopic images: (kV) (mm)
i) 50 mGy/min for equipment not equipped with an 60 1.9
automatic intensity control; 70 2.1
ii) 100 mGy/min for equipment equipped with an 80 2.4
automatic intensity control; and
90 2.7
iii) 150 mGy/min for equipment equipped with both 100 3.0
an automatic intensity control and a high-level
110 3.4
irradiation control and the high-level irradiation
control is activated. 120 3.8

9. Transmitted/Scatter Radiation from Imaging Assembly— 130 4.2

The radiation resulting from the transmission of the X-ray 140 4.6
beam through, or scattered from the entrance window of the
radioscopic imaging assembly must not exceed an air kerma
rate of 2 mGy/h for an entrance air kerma rate of 1 Gy/min.
6. Preview Image—A preview image must be provided on
10. Last Image Hold—Radioscopic equipment must be which the operator may set up the tomographic sections to be
equipped with a last image hold system which keeps on taken. The reference lines indicating these sections must not
display the last radioscopic image obtained. differ from the true position by more than 2 mm with the
gantry in vertical position.
2.5.4 Computed Tomography
7. Light Field—A light field must be provided for marking
Equipment Requirements
the tomographic section or reference plane. The light must be
1. Irradiation Control—Initiation or continuation of irradi- visible under ambient light conditions of up to 500 lx. The
ation must be possible only from the control panel. width of the light field must not exceed 3 mm, measured in the
2. Visual Indications—All CT conditions of operation such centre of the gantry opening, and the coincidence of the
as the section thickness, pitch factor, and filtration to be used centre of the light field and the centre of the tomographic plane
during a scan series must be indicated prior to the initiation of must be within 2 mm. If more than one tomographic section
a scan or scan series. On equipment having all or some of these is acquired at a time, the accompanying documentation must
CT conditions of operation at fixed values, this requirement describe the position of the light field in reference to the
may be met by permanent markings. Indication of CT condi- tomographic section.
tions of operation must be visible from any position from 8. Motion of Patient Support—For motions of the patient
which scan initiation is possible. support beginning at a typical starting position, and continuing
to a position which is the lesser of the maximum selectable
scan increment or 30 cm, and returning to the starting posi-
tion, the deviation between the actual and the indicated
distances must not exceed 1 mm. This test must be performed

26 Safety Code 35
with a load not exceeding 135 kg evenly distributed across The following data must be provided:
the patient support. Measurements of actual versus indicated (a) The CTDI100 must be provided at the following
distances may be taken anywhere along the travel. locations in the dosimetry phantom:
9. Accuracy of Recorded Examination Data—In normal use i) along the axis of rotation of the phantom;
the information indicating the orientation of the displayed
image with respect to the patient must be displayed with each ii) along a line parallel to the axis of rotation and
image. 1.0 cm interior to the surface of the phantom with
the phantom positioned so that CTDI100 is the
2.5.5 Dose and Image Quality Information for maximum obtainable at that depth;
Computed Tomography Equipment iii) along lines parallel to the axis of rotation and
The initial or baseline dose and image information required to 1.0 cm interior to the surface of the phantom at
assess the continuing performance of a CT X-ray system is positions 90, 180 and 270 degrees from the posi-
normally obtained from the manufacturer at the time of tion in 2.5.5(2)(a)(ii) above. The CT conditions of
purchase. For existing equipment, baseline values should be operation must be the typical values suggested by
established by a medical physicist. the manufacturer for CT of the head or body. The
location of the position where the CTDI100 is max-
The following safety and technical information regarding the imum as specified in 2.5.5(2)(a)(ii) must be given
X-ray dose delivered by the radiation beam must be deter- by the manufacturer with respect to the housing of
mined: (US CFR 1020.33), (IEC 2002 ). the scanning mechanism or other readily identifi-
able part of the CT scanner in such a manner as to
1. The CT conditions of operation used to obtain the infor- permit placement of the dosimetry phantom in this
mation required in subsections 2 and 3 of this section. orientation.
(b) The CTDI100 in the centre location of the dosimetry
2. Dose information, separate for systems used to image phantom for each selectable CT condition of operation
the head and/or image the body must be provided. All dose that varies either the rate or duration of irradiation or the
measurements must be performed with the CT dosimetry nominal tomographic section thickness. This CTDI100
phantom placed on the patient couch or support device with- must be presented as a value that is normalized to the
out additional attenuating materials present. CTDI100 in the centre location of the dosimetry phantom
Dose information must be given in terms of the Computed from section 2.5.5(2)(a), with the CTDI100 of 2.5.5(2)(a)
Tomography Dose Index (CTDI100), which is the integral having a value of 1. As a single CT condition of operation
of the dose profile produced in a single axial scan along a is changed all other independent CT condition of opera-
line perpendicular to the tomographic plane (from -50 mm tion shall be maintained at the typical values described in
to +50 mm) and divided by the product of the number of 2.5.5(2)(a). These data shall encompass the range of each
tomographic sections N and the nominal tomographic section CT condition of operation stated by the manufacturer as
thickness T, that is, appropriate. When more than three selections of a CT condi-
tion of operation are available, the normalized CTDI100
+ 50 mm must be provided, at least for the minimum, maximum and
CTDI 100 = ∫
D( z)
N ×T dz one mid-range value of the CT condition of operation.
− 50 mm (c) The CTDI100 at the location coincident with the
where maximum CTDI100 at 1.0 cm interior to the surface of the
z is the position along a line perpendicular to the dosimetry phantom for each selectable peak X-ray tube
tomographic plane, voltage. When more than three selections of the peak
D(z) is the dose at position z perpendicular to the to X-ray tube voltage are available, the normalized CTDI100
mographic plane, where doses are reported as must be provided at least for the minimum, maximum and
absorbed dose to air, one mid-range value that is normalized to the maximum
CTDI100 located at 1.0 cm interior to the surface of the
N is the number of tomographic sections produced in dosimetry phantom from 2.5.5(2)(a) above, with the
a single axial scan of the X-ray source, and CTDI100 of 2.5.5(2)(a) having a value of 1.
T is the nominal tomographic section thickness. (d) The dose profile in the centre location of the
dosimetry phantom for each selectable nominal tomo-
This definition assumes that the dose profile is centred on graphic section thickness. When more than three selec-
z = 0. tions of nominal tomographic section thicknesses are
available, the information must be provided, at least, for
the minimum, maximum, and mid-range value of nominal

Safety Code 35 27
 tomographic section thickness. The dose profile must be The computed tomography number, or CT number,
presented on the same graph and to the same scale as the represents the mean X-ray attenuation associated with
corresponding sensitivity profile required by 2.5.5(3)(d). discrete areas of the CT image, and is expressed in
(e) a statement of the maximum deviation from the Hounsfield units, where the scale is defined so that water
values given in the information provided according to and air have values of 0 and -1000 respectively, and is
2.5.5(2)(a) to 2.5.5(2)(d). Deviation of actual values may following the relationship:
not exceed these limits. μ x − μ water
CTnumber = × 1000
3. Imaging performance information, listed below, must μ water
be provided for the CT conditions of operation used to pro-
vide the information required in 2.5.5(2)(a). All other aspects where
of data collection, including the X-ray attenuation properties µx is the linear attenuation coefficient for the material
of the material in the tomographic section, shall be similar to of interest, and
those used to provide the dose information required in
2.5.5(2)(a). For any CT X-ray system designed to image both µwater is the linear attenuation coefficient for water.
the head and body, separate imaging performance information
must be provided for each application. (b) A graphical presentation of the modulation transfer
(a) A statement of the noise. Noise is defined as the function (MTF) for the same image processing and
standard deviation of the fluctuation in CT number. It can display mode as that used in the statement of the noise.
be quantified in HU or expressed as a percentage of the (c) A statement of the nominal tomographic section
linear attenuation coefficient for water using the following thickness at the centre of the imaged section.
formula: (d) A graphical presentation of the sensitivity profile
at the centre of the imaged section for each selectable
CS × SDx × 100% nominal tomographic section thickness for which the dose
Noise =
μ water profile is given according to section 2.5.5(2)(d).
(e) A description of the phantom or device and test
where protocol or procedure including analysis of errors used to
CS is the contrast scale, defined below, obtain the information referred to in 2.5.5 (3)(a),(b),
SDx is the measured standard deviation of the CT (c),(d).
number of picture elements in a specified region of
interest of the CT image, and 4. Diagnostic reference levels are described using CTDIw
which is the weighted CTDI100. CTDIw is defined as:
µwater is the linear attenuation coefficient for water.
1 2
The contrast scale is defined as the change in linear CTDI w = CTDI 100( centre ) + CTDI 100( peripheral )
attenuation coefficient per CT number relative to water
3 3
and the value of the contrast scale must be within where
preset acceptable limits. It is approximately equal to
2 x 10-4 cm-1 HU-1 for beam energies of 100-140 kV. It is

CTDI100(centre) is the value in the centre of the
calculated from the following equation: phantom, and
CTDI100(peripheral) is the value measured in the
μ x − μ water periphery of the phantom.
Contrast Scale =
CTx − CTwater
This CTDIw must be displayed on the operators console,
where: reflecting the type of examination selected, head or body, and
µx is the linear attenuation coefficient for the material the CT conditions of operation.
of interest,
µwater is the linear attenuation coefficient for water, 5. The dose-length product (DLP) is also used as an indica-
tor of overall exposure for a complete examination in order to
CTx is the CT number for the material of interest, and allow comparison of performance against a reference dose
CTw is the CT number for water. value set for the purpose of promoting optimization of patient
protection. The DLP is calculated as:

28 Safety Code 35
 This area is usually in or near the X-ray room. The location of
DLP = ∑ CTDI
i
w
×T× N loaded and unexposed cassettes must be clearly marked. The
area should be large enough to accommodate the required
where:
supply of cassettes needed during the operation of the facility.
i represents each scan sequence forming part of
an examination, 3.1.2 Cassette and Screen
CTDIw is the weighted CTDI, Cassettes or screens in poor conditions will impair diagnostic
T is the slice thickness, and quality. Problems are caused by dirty or damaged screens,
warped cassettes, fatigue of foam compression material or
N is the number of slices in the sequence.
closure mechanism, light leaks, and poor film-screen contact.
Cassettes should be checked regularly for wear and cleanli-
ness and any damaged cassettes should be replaced.
3.0 Image Processing Systems Manufacturers’ recommended screen cleaner should be used.
Image processing includes both film and digital processing To avoid artifacts caused by dirt and dust, the intensifying
of radiological images. Film processing systems have been screens and cassettes should be cleaned at least monthly. The
extensively used in the past. Recently with advances in digital intensifying screens should be inspected with an ultraviolet
technology, digital image processing systems are being used in light to find dust particles. Cleaning tools include a screen
many radiological facilities. No matter the type of system used, cleaner with antistatic solution, lint-free cloths, compressed
optimization of image quality at an acceptable dose to the air, and a camel hair brush. Cassettes and screens should be
patient is a priority for radiological facilities. This is achieved numbered for identification and matching, both inside the
by ensuring image processing is an integral component of the cassette and on the outside of the cassette.
facility’s quality assurance program.
3.1.3 Darkroom
With the exception of daylight automatic image processors not
3.1 Film-Based Systems requiring darkrooms, automatic film processors require prop-
erly designed darkrooms. While specific details may vary from
The ability to produce a radiograph of satisfactory diagnostic installation to installation, all darkrooms must include certain
quality at an acceptable dose to the patient depends on the basic features:
technique used when performing the examination, the appro-
1. The room must be light-tight. Particular attention must be
priate selection of loading factors, the film-screen employed,
paid to the door seal and the mounting of the film processor if
the handling and processing of the film, and on the conditions
the film insertion to the processor is done through a wall. The
of viewing the image. Good image quality requires proper
darkroom should incorporate a lockable door or double doors
darkroom techniques, routine processor quality control
to ensure light-tightness when undeveloped films are being
monitoring, and careful adherence to film and processor
handled. A film strip exposed to an optical density of 1.2 units
manufacturers’ instructions.
must not show an increase in optical density greater than
0.05 units in two minutes exposure to the darkroom light
3.1.1 X-ray Film
environment.
X-ray films are sensitive to light, heat, humidity, chemical
2. If the darkroom is adjacent to a radiographic room, the
contamination, mechanical stress and X-radiation. Unexposed
film storage container must be adequately shielded to
film must be stored in such manners that it is protected from
ensure that excessive exposure of film by X-rays does not
stray radiation, chemical fumes and light. The level of optical
occur. Sufficient film shielding must be in place to reduce the
density from the base material and film fog from all causes
radiation level to the film to 0.1 mGy and to the loaded
must not be greater than 0.30 O.D.
cassettes to 0.5 µGy.
Generally, X-ray films should be stored on edge, in an area 3. A warning light should be located outside the darkroom,
away from chemical fumes, at temperatures in the range of at the entrance, to indicate when the room is in use. The warn-
10∘C to 21∘C and humidity between 30% and 60%. The film ing light is not required if the door is locked when it is closed.
manufacturers’ instructions must be followed. Sealed film 4. Safelights, fitted with bulbs of intensity not greater than
packages must be allowed to reach room temperature before 15 watts, must be provided above the work areas inside the
opening to prevent condensation on the films. darkroom. The safelight must have filters appropriate to the
specifications of the film used and must be positioned at dis-
Loaded cassettes must be stored in an area shielded from ex- tances greater than 1 metre from work areas to minimize film
posure to radiation. Radiation exposures to stored film must fogging.
be limited to 0.1 mGy and, for loaded cassettes, to 0.5 µGy.

Safety Code 35 29
5. The darkroom should be under positive pressure so that 1. The only acceptable method to monitor the operation
chemical fumes and dust are not sucked into the room when of an automated image processor is with the use of a sensito-
the door is opened. The processor should be vented to the out- meter to produce repeatable light exposure of the film and with
side. The number of air changes must be high enough for the the use of a densitometer to monitor the processed sensito-
processor to operate properly and not create a hazardous metric film. Processor monitoring must be done each opera-
situation for personnel. tional day when the processor is started and has stabilized, and
at additional times after the processor has been cleaned, or
Cleanliness in the darkroom and of the screens and cassettes is after fresh chemicals have been added. The processor must be
essential. It is important to maintain the cleanest environment given sufficient time to stabilize, before processing patient
possible in order to minimize any artifacts caused by dirt, dust, radiographs.
or improper handling of film. An ultraviolet light should be 2. Manufacturers’ instructions with respect to strength of
used to find dust areas around the darkroom. No one should eat solution, temperature and time must be followed to
or drink in the darkroom area. All working surfaces, tops of ensure optimum development.
counters and the floor should be cleaned regularly, at least once
a day. Tops of cabinets, vents, light fixtures and any other areas 3. Developing solutions must be replenished as necessary
which can collect dust should be cleaned on a regular basis. and must be changed or recycled regularly, as required. This
The ventilation system should be checked to make sure that should be done often enough to avoid oxidation of the devel-
no dust is carried from it to the inside the darkroom; any filter oping solutions. Even unused developer deteriorates with time.
should be changed on a regular basis. Chemicals should not Processing chemicals must be protected from freezing.
be mixed inside the darkroom since this operation can result in Manufacturers’ instructions must be followed in storing
chemical splashes onto the equipment or working surfaces. chemicals to avoid oxidation. Any chemicals showing signs of
Personnel should wear personal protection devices (gloves, oxidation or sedimentation must not be used.
masks, etc.) when handling chemicals. 4. Fixer must be adequately removed from the processed
films. Manufacturers’ instructions for film wash must be fol-
To avoid putting fingerprints on the film and to avoid dirtying lowed. Fixer retention tests must be done on a regular basis.
the screens, it is important to wash hands frequently with soap The fixer is responsible for stopping the development process
that does not leave any residue. Clutter which may collect dust by removing silver halide crystals remaining on the film. In-
should be eliminated. Corrugated cardboard boxes containing sufficient washing of films for the removal of fixer will result
film boxes, chemicals, and other supplies should not be stored in staining of films and compromise film storage time.
or opened inside the darkroom as they will create a lot of dust. 5. Cleanliness is extremely important for reducing film
The boxes should be opened outside the darkroom, and films artifacts. The film transport mechanisms of film processors
and supplies carried inside. Any articles of clothing made of must be cleaned frequently. Abrasive cloths or cleaners should
loose fibres or which are static generating, such as wool, silk, never be used on processors.
some cottons or cotton blend fabrics, should not be worn in
6. Film processors must be maintained regularly, according
the darkroom or should be covered with a laboratory coat.
to manufacturers’ instructions. The accuracy of the processor
thermometer should be checked regularly against a non-
3.1.4 Film Processing
mercury thermometer. The digital processor thermometer
Improper or careless processing of exposed radiographic films should be accurate to within 0.5∘C.
can result in films of poor diagnostic image quality and
7. When film processing volume is less than 50 films
consequently increase the possibility of wrong diagnosis or
per day, it may not be possible to adequately control chemical
requests for repeat X-ray examinations. To achieve full devel-
concentrations and activity. In this situation, flood replenish-
opment, the film must be processed in chemically fresh
ment should be used to better control chemical concentrations.
developer, at the correct temperature and for sufficient time to
ensure that the silver in exposed silver halide crystals in the 8. When film processing volume is at least 50 films per day,
film emulsion is completely reduced. If this is not done, the a volume replenishment system is generally used which
blackening of the film will not be optimum and the tendency replenishes processing solutions each time a film is fed into
will be to increase radiation exposure to achieve proper image the processor. Manufacturers’ specifications for replenishment
density. of processor solutions should be followed.

Other factors can also affect the quality of the processed film. X-ray film processing generates silver containing wastes.
These include cleanliness of the processing system, film Silver containing chemicals must not be disposed of directly
immersion time, and the efficiency of the rinsing. To ensure into the sewer system. These chemicals must be collected and
proper processing of films certain basic procedures must be released to the appropriate waste management agency for
followed:

30 Safety Code 35
disposal and/or recycling. The management of silver contain- regular basis. With normal use, the accumulation of dust, dirt,
ing waste must be carried out in accordance to provincial and scratches and cracks may reduce image quality. Exposure to
municipal requirements. chemical agents, such as non-approved imaging plate clean-
ers, handling with dirty or wet hands or contact with hand
3.1.5 Viewbox lotions are all possible causes of imaging plate damage. It is
The conditions of viewboxes must be checked regularly along recommended that a log book be maintained to track the phys-
with the conditions under which radiologists and other ical conditions of all imaging plates and cassette assemblies.
health care professionals examine radiograms since this may The cleaning frequency depends on patient volume, plate
influence diagnostic accuracy. Problems with improper handling, and the frequency at which artifacts are perceived.
illumination due to the non-uniformity of fluorescent tubes In general, a weekly visual inspection for dust and dirt is
or degradation and discolouration of the viewing surface must recommended. The imaging plates must be cleaned monthly
be corrected. following manufacturer recommended procedures and using
manufacturer recommended cleaners. Cleaner must not be
poured directly onto the plates as this may cause staining.
3.2 Digital Imaging Systems
3.2.2 CR Cassette
As an increasing number of imaging modalities are being Under normal conditions of use, dust and dirt can accumulate
introduced based on digital technology, imaging facilities are on cassettes. It is recommended that a log book be maintained
migrating from film-based to filmless digital imaging systems. to track the physical conditions of all cassettes. In general, a
Digital images can be acquired using either computed radiog- weekly visual inspection for dust and dirt is recommended and
raphy or digital radiography systems. Computed radiography monthly cleaning of CR cassettes following manufacturer
systems, or CR systems, consist of a cassette, an imaging plate recommended procedures and using manufacturer recom-
and imaging plate reader. The CR cassette, loaded with an im- mended cleaners. The outside of the cassette can easily be
aging plate, is positioned in the X-ray system, as it is done with cleaned with water and soap or a non-aggressive cleaner. The
film cassettes. Upon X-ray exposure, the imaging plate, which inside must not be cleaned with soap and water, since soap
contains a photostimulable storage phosphor, stores the latent residue may be left on the protective coating after cleaning.
image. The imaging plate is then read and a digital image is
produced. For digital radiography systems, or DR systems, the 3.2.3 Electronic Display Devices
image receptor is a flat panel detector which converts the X-ray
The performance of medical electronic display devices must
signal into an electronic signal carrying the image informa-
be checked routinely. The cleanliness of the display surface
tion. The electronic signal is sent to a digital image processor
must be maintained. Manufacturer recommended cleaners
and the image is displayed almost instantaneously. Digital
and cleaning procedures must be followed. The performance
imaging systems together with systems for storage and com-
of the display must be verified using test patterns designed for
munication of digital images have the potential to significantly
evaluating various characteristics of display performance
improve patient care by increasing the efficiency of patient
(AAPM, 2005). An overall assessment should be made daily
examinations, facilitating rapid electronic communication
prior to clinical use. It is recommended that geometric distor-
between health care providers, both within and outside a
tion, luminance and resolution be evaluated monthly and a
facility, and ultimately increasing patient throughput .
detailed evaluation be performed annually by a medical
physicist.
Quality control testing of digital image systems is essential.
Verification of the proper functioning of the X-ray imaging
3.2.4 Picture Archiving and Communications System
equipment along with appropriate selection of technique and
loading factors remains essential for obtaining a satisfactory In digital imaging, a system must be in place to manage patient
image at a minimal dose to the patient. For digital systems, images so that secure storage and timely retrieval of images is
specific quality control testing must also be performed on the possible. Picture Archiving and Communications System
image acquisition, storage, communication and display sys- (PACS) is one such system which is widely used in radiology.
tems. In section C of this Safety Code, some general quality A PACS in an imaging facility connects digital image acqui-
control tests have been included for digital imaging systems. sition devices with a systems which can store, retrieve and
In addition to these test, all equipment- specific, manufacturer- display digital images within and outside the facility. The
specified tests must also be performed. transition to PACS requires a significant amount of planning,
time and resources. However, once established, a PACS offers
3.2.1 Computed Radiography Imaging Plates a number of advantages such as improved productivity,
widespread, simultaneous access to images and image
Computed radiography (CR) imaging plates are reusable and
manipulation. Radiologists are able to interpret more cases in
can be exposed, read and erased repeatedly. For this reason, it
shorter periods of time, resulting in shorter waiting times for
is necessary to evaluate the conditions of imaging plates on a

Safety Code 35 31
patients and quicker access to results by the referring physi- feature should be available which pre-fetches prior studies of
cians. However, attention must be given to ensure that the qual- the individual to allow for comparison with the current study
ity of patient images is maintained and that patient information being interpreted.
is not lost or unintentionally altered. Such situations can lead 5. The system should adapt to the user. For example, the
to repeat radiological examinations and misdiagnoses of graphical interface on the display should adapt to the
patients. preferences of the individual signing into the system.

3.2.5 PACS Implementation 6. A system must be in place for quick and efficient error
correction. Files containing incorrect information may quickly
When deciding whether to implement a PACS, a number of become lost and unretrievable. On a regular basis, the systems
key issues should be addressed. A PACS is a very high capital should ensure agreement between the list of studies planned
investment. It requires resources for hardware, software and for a work period, the studies performed at the modalities,
additional staff such as a PACS administrator and any con- and the studies interpreted by the radiologists. This will min-
sultants which may be necessary. Early in the planning stages imize lost cases and ensure incorrectly filed data is quickly
of a PACS, parties should be consulted from all areas which identifiable.
will be affected by the changes. This should include depart-
mental administrators, PACS specialists, medical physicists, 7. Fault Tolerance. When working with a digital imaging and
radiologists, technologists, referring physicians and any exist- reporting system, attention must be given to ensure system
ing information technology (IT) staff. The information availability. Critical patient data must be available whenever
obtained during the consultation should be used to perform an needed. This is especially important in operating rooms and
intensive cost/benefit analysis prior to making a decision. emergency departments. When purchasing equipment for im-
Early consulting with all involved parties will facilitate the aging or information systems, the vendor must guarantee the
clinical acceptance of the system. level of availability of their system. System down times, for
upgrades and maintenance must be well planned so as not to
When deciding upon the specifications of a PACS system the interfere with the workflow of the facility. Depending on the
following key components should be considered. type of facility and the workload, purchasers may require the
vendor to guarantee as much as 99.999% availability. It must
1. Insist on Digital Imaging and Communications in be determined if it is acceptable for the whole system or parts
Medicine (DICOM) compliance. The DICOM standard of the system to be down at any time and the duration of the
facilitates interoperability of medical imaging equipment. time. Penalties and conditions for not meeting the uptime and
2. Ensure that all systems can be integrated. This includes downtime guarantees must be clearly stated and agreed upon
systems such as the Hospital Information System (HIS), the with the vendor.
Radiology Information System (RIS), the PACS, image 8. Disaster Recovery. The facility should establish a
acquisition equipment, printers, and any reporting systems. To disaster recovery plan in case of component failure or
ensure ease of integration between systems, equipment should catastrophic events. The disaster recovery plan should consist
support the “Integrating the Healthcare Enterprise” (IHE) of documented policies and procedures identifying primary
Technical Framework. The IHE is an initiative to promote and and backup people and their responsibilities and a description
support the integration of information systems in the health- of the actions necessary to restore operations. A critical com-
care enterprise to improve the workflow by facilitating ponent of disaster recovery is the continuous backing up and
communication between systems from different vendors. In- maintenance of data at an off-site location
formation being transferred from one system to another will
remove the need to re-enter information independently into 9. In order for a PACS system to work, it should be based
each system and thus avoid inconsistencies, redundancies and upon, and designed to reflect, a proven, effective workflow.
unavailability of the data. Purchasers must ensure the vendor understands the facility
workflow and provides a system which does not disrupt the
3. Security of patient information must be a priority. Only workflow. PACS systems based upon flawed work flows will
authorized individuals must be able to access patient data and carry over all of the existing problems.
images. Security measures must be established to control ac-
cess to patient information as well as to track all activities 10. When deciding upon the network and storage require-
which are performed on the data. This includes monitoring ments of an imaging or information system it is important not
who accesses information, when the information is accessed, to limit the systems to only the current needs of the
and what changes are made to the information. Authorized facility. The system should be scalable to allow for future
system users must understand the importance of keeping growth of the system. The system capacity should be based
system passwords confidential. upon the following points:

4. Automated features should be included in the design of

the system to facilitate more rapid workflow. For example, a

32 Safety Code 35
 i) the current modalities from which studies are the original images must only be permitted to be
acquired; used when there is no other means of displaying
ii) the average number of images per study by the original images themselves. When this is the
modality; case, the matrix size of the captured images must
not be less than the matrix size of the original
iii) the number of pixels and bit depth of the image; images, and the bit depth must be 8 bits or equal to
iv) number of studies performed each year; that of the original images.
v) projected procedure growth volume; iv) Images captured from a film scanning device must
vi) modalities to be added in the future; and have:
vii) other sites/facilities to be added to the system (I) an acquisition or digitization system which
in the future. enables spatial resolution of a minimum of
2.5 lp/mm and acquisition of 10 bit grey scale;
3.2.6 Teleradiology (II) a display system which enables spatial reso-
Teleradiology is the electronic transmission of radiological lution of a minimum of 2.5 lp/mm and display of
images from one location to another for the purposes of inter- 8 bit grey scale.
pretation and/or consultation. Through teleradiology, digital 2. Image Management (for static images only)—Teleradiol-
images and patient information can be accessed electronically ogy systems are imaging systems that require the use of image
from multiple sites simultaneously. The benefits of teleradiol- management for optimal performance. All systems must
ogy include more efficient delivery of patient care and the include the following:
ability to provide radiological services to facilities in remote i) An integrity-checking mechanism, either in soft-
areas which do not have radiologists available on-site. ware or using a manual process, to ensure that all
transmitted information from the site of origin is
Since teleradiology involves the acquisition and interpretation received intact by the receiving site.
of patient images at different sites, it is important that policies
and procedures be in place at all locations to ensure image ii) Capability for the selection of the image sequence
quality is optimized and comparable among all facilities for transmission and display at all receiving sites.
accessing patient images. This is especially important when iii) Annotation capabilities for use at the transmitting
official authenticated written interpretations are made through station that must identify the patient accurately and
teleradiology. unambiguously. This may include patient name,
identification number, date and time of examina-
1. Teleradiology Quality Assurance—The Canadian Associ- tion, film markers, institution of origin, type of
ation of Radiologists has produced guidelines for facilities examination, degree of compression (if used) and
performing teleradiology. Some of the main points of that doc- a brief patient history. This information should
ument relevant to this Safety Code are listed below (CAR, be bundled with the image file but may also be
1999). transmitted by other secure means.
When used for rendering the official authenticated inter- iv) The transmitting site should have provision for
pretation of images, the receiving location must conform to interactive window and level and/or brightness and
the following requirements: contrast.
i) Images acquired digitally by an imaging device v) Provision for the selection of appropriate com-
must be displayed in their full native matrix size pression for improved transmission rates and
and bit depth. If this is not possible, display soft- reduced archiving/storage requirements.
ware must be used that allows the user to “pan” vi) Image storage at either the transmitting or receiv-
over the entire image when displayed in its full ing site as well as transmission must be arranged
matrix size. such that patient confidentiality is maintained and
ii) Images obtained through post processing of the that the system is secure.
original image must not be used to the exclusion vii) The provider must ensure that the image quality is
of the original images themselves. They must only the same at the transmitting site and receiving
be used to support the interpretation process. site(s).
iii) Digital images may be “captured” using a frame- 3. Transmission of Images and Patient Data—Communica-
grabber interfaced to a secondary (analog) device, tions protocols, file formats and compression must
such as a display monitor on a console being used conform to the current DICOM 3.0 network standards.
to display the original images acquired digitally.
Such images captured from displayed versions of

Safety Code 35 33
4. Display Capabilities—Display workstations employed receiving facility provided that they are stored at the transmit-
for teleradiology systems must provide the following charac- ting site. However, if images are retained at the
teristics: receiving site, the retention period of that jurisdiction must
i) Luminance of the grey scale monitors must be also be met. The policy on record retention must be in writing.
at least comparable to the workstations used for 8. Documentation—Communication is a critical component
acquisition. of teleradiology. Physicians interpreting teleradiology
ii) Display stations for digitized radiographic films, examinations must render reports in accordance with the CAR
and digital radiography must include: Standards of Communication.
(I) brightness and contrast and/or interactive 9. Quality Control for Teleradiology—It must be stressed
window and level function; that the images at the receiving site can only be as good as the
images captured at the transmission end. It is imperative that
(II) a magnification function; an imaging physician must be at the transmitting site on a reg-
(III) the capability of rotating and flipping the ular basis to ensure that the equipment is functioning properly
displayed images; and that the technologists are adequately supervised and
(IV) the capability of accurate linear meas- trained. Both the transmitting and receiving sites must have
urements; and documented policies and procedures for monitoring and eval-
uating the effective management, safety, proper performance
(V) the capability of inverting the grey scale
of imaging, transmitting, receiving and display equipment.
values of the displayed image.
A test image, such as the SMPTE, or its equivalent, must
iii) Display stations for CT must accurately reproduce
be captured and transmitted at least weekly to test the overall
the original study and be equipped with similar
operation of the system. As a dynamic range test, both the
functional capabilities as the workstation used for
0/5% and the 95/100% areas must be seen as distinct from the
acquisition.
respective adjacent 0% and 100% areas.
5. Patient Database—For radiological images transmitted
10. Quality Improvement—The use of teleradiology does not
by teleradiology, a database must be available, at both the
reduce the responsibilities for the management and
transmitting and receiving site to serve as a basis for
supervision of radiological medicine. Procedures must be
future integrity checking and audits. The data base must
systematically monitored and evaluated as part of the overall
include:
quality improvement program of the facility. Monitoring must
i) patient name, identification number and date; include the evaluation of the accuracy of the interpretations
ii) type of examination; as well as the appropriateness of the examination. Incidences
iii) types of images; of complications and adverse events must be reviewed to
identify opportunities to improve patient care.
iv) number of images;
The use of teleradiology must be documented. Periodic
v) image acquisition and sending sites (if different); reviews must be made for the appropriateness, problems and
and quality of the transmitted data. The data must be
vi) date and time of transmission. collected in a manner which complies with the statutory
6. Security—Teleradiology systems must provide network and regulatory peer-review procedures to protect the confi-
and/or software protocols to protect the confidentiality of the dentiality of the peer-review/patient data.
patient’s record(s), image(s), interpretation(s) and other data
and insure that the system is secure and used only on an as
needed basis by those authorized by the patient according to
provincial or territorial privacy of information legislation and 4.0 Other Equipment
Canadian Medical Association guidelines.
7. Storage of Records—The legal requirements for the Consideration must be given to other equipment, such as those
storage and retention of images and reports will vary from used for personnel protection and equipment testing, which
province to province and the providers of the tele- are necessary for ensuring the radiation safety of a radiologi-
radiology service are responsible for adhering to these cal facility. Personnel protective clothing must provide
requirements. Images stored at either site must meet adequate protection without being unduly restrictive and
the jurisdictional requirements of the transmitting site. heavy. All test equipment must be properly maintained and
Images interpreted off-site need not be stored at the carefully stored.

34 Safety Code 35
4.1 Protective Equipment 2. All sensitometric and densitometric equipment, dose
meters, tube voltage meters should be calibrated on a regular
1. Protective lead aprons must provide attenuation equiva- basis according to manufacturers’ recommendations.
lent to at least 3. All phantoms and other equipment used for the assess-
(a) 0.25 mm of lead, for examinations where the peak ment of image quality, dose and system performance should
X-ray tube voltage is 100 kV or less, be checked for damage or any condition which may affect their
(b) 0.35 mm of lead, for examinations where the peak use.
X-ray tube voltage is greater than 100 kV and less 4. Test equipment should be stored away from heat, direct
than 150 kV, and sunlight, and high humidity. They must be operated
(c) 0.5 mm of lead, for examinations where the peak following manufacturers’ recommendations.
X-ray tube voltages is 150 kV or greater.
2. For interventional procedures, where no other protective
devices are used, full wrap around type protective gowns of
0.50 mm Pb in the front panels and 0.25 mm Pb in the back
5.0 Radiation Protection Surveys
panels are recommended. A radiation protection survey is an evaluation, conducted by an
3. For interventional procedures, protective thyroid shields expert, of the radiation safety of a radiological facility. The
with an equivalent of 0.50 mm Pb are recommended. survey is intended to demonstrate that the X-ray and auxiliary
4. For interventional procedures, in the situation where scat- equipment function properly and according to applicable stan-
ter radiation to the lenses of eye could approach the annual dards, and that the equipment is installed and used in a way
equivalent dose limit of 150 mSv, the use of leaded glasses is which provides maximum radiation safety for operators,
recommended. patients and others. Safety measures such as protective equip-
ment and shielding are also examined to ensure that they are
5. Protective gonad shields for patients must have a lead present and provide the required protection. It is important,
equivalent of at least 0.25 mm Pb and should have a lead therefore, that X-ray facilities are inspected at regular
equivalent thickness of 0.5 mm at 150 kVp. Gonad shields intervals.
must be of sufficient size and shape to exclude the gonads
completely from primary beam irradiation.
6. Protective gloves or gauntlets must possess at least a 5.1 General Procedures
0.25 mm Pb equivalency. Thess protections must be provided
throughout the glove, including fingers and wrist. Routine operation of any new installation or an installation
which has undergone modifications should be deferred until a
7. The lead equivalent thickness of the protective material
complete survey has been made by an expert. The expert is
used must be permanently and clearly marked on all
an individual who is qualified by education and experience
protective equipment and apparel.
to perform advanced or complex procedures in radiation pro-
8. Ceiling-mounted lead acrylic screens and moveable tection that generally are beyond the capabilities of most
shields should provide protection equivalent to at least personnel within the facility. These procedures include evalu-
0.50 mm Pb. The attenuation value must be marked on all ation of the facility design to ensure adequate shielding is in
protective screens and shields. place, inspection and evaluation of the performance of X-ray
9. All protective equipment must be tested on a yearly basis equipment and accessories, and evaluation and recommenda-
for integrity and results must be included in the quality control tion of radiation protection programs. The owner of the facil-
test records. ity (or another delegated staff member such as the Radiation
10. Defective equipment must be removed from clinical use. Protection/Safety Officer) must contact the appropriate regu-
latory agency to ascertain inspection and acceptance testing
11. Protective equipment must be stored and maintained procedures in that jurisdiction. Some jurisdictions may require
according to manufacturers’ instructions. that the facility be declared in compliance with applicable
governmental regulations prior to operations.

4.2 Test Equipment For a new facility, it is particularly advantageous to make

visual inspections during construction, to ensure compliance
1. All equipment used for acceptance and quality control with specifications and to identify faulty material or work-
testing must be evaluated for their functioning and manship, since deficiencies can be remedied more economi-
performance on a regular basis. cally at this stage than later. Such inspections should include
determination of thickness of lead and/or concrete thickness

Safety Code 35 35
and density, degree of overlap between lead sheets or between 2. identification of the X-ray equipment (i.e., the name
lead and other barriers, as well as thickness and density of of the manufacturer, model designation and serial number
leaded glass used in viewing windows. of the generator, control, X-ray tube assembly, X-ray table,
etc. as applicable) and the date, or at least approximate date
For existing installations, a survey must be carried out after manufactured;
any changes are made, which might produce a radiation 3. the method of support of the X-ray tube assembly (i.e.,
hazard. This includes alteration of protective barriers, equip- floor-to-ceiling tube stand, ceiling suspended over-table tube,
ment modification and replacement, changes in operating etc.);
procedures, or increased workloads.
4. observations of the operational conditions (both electri-
Finally, radiation protection surveys must be carried out at cal and mechanical) of the X-ray equipment at the time of the
regularly scheduled intervals during routine operations to survey;
detect problems due to equipment failure or any long-term 5. the actual or estimated total workload of the facility, as
trends toward a decrease in the level of radiation safety. well as the workload apportioned into various X-ray beam
The frequency at which radiation protection surveys are to directions and procedures used, etc.;
be conducted is dependant on the type of facility, the type 6. results of radiation measurements carried out both inside
of equipment used and the type of examinations performed. and outside the controlled area under “typical” operating con-
Facilities should contact the applicable regulatory authority to ditions. The locations at which the measurements are made;
establish the survey schedule.
7. an assessment of the condition of patient restraints,
protective aprons, gloves, mobile protective barriers and other
The results of such surveys, including conclusions drawn by
protective devices;
the expert, must be submitted to the owner or responsible user
in a written report. All such reports must be retained by the 8. an estimate of potential exposures to personnel and
owner or responsible user. For federal facilities, radiation sur- general public in or around the facility;
vey reports should be maintained for 5 years and personnel 9. an evaluation of the X-ray performance and the imaging
dosimetry records for the lifetime of the facility. or diagnostic performance (this may include performing
applicable quality control tests from sections C3.1 to C3.6;
10. a summary of typical loading factors used and a meas-
5.2 Survey Report urement of the total filtration in the X-ray beam;
The survey report must present, in a clear systematic way, 11. an assessment of radiological techniques from the point
details and results of the measurements carried out, as well of view of radiation safety and an assessment of the
as the conclusions drawn and recommendations made by the Diagnostic Reference Levels for the facility. Attention must
surveyor. Any unusual findings about the equipment itself, the be drawn to any practices which are or could be detrimental to
facility or operating procedures, which could affect the safety the patient or to personnel working in the facility. Recom-
of operators or other persons in the vicinity of the X-ray mendations of improved or safer techniques should be made in
facility must be clearly identified. such cases;
12. results of investigations of any unusually high exposures
The survey report must include the following: from previous personnel dosimetry reports and recommenda-
1. a sketch of the facility, showing the location of the X-ray tions on whether other persons should be included in the
equipment and control booth within the facility as well as the personnel dosimetry service;
nature and occupancy of the areas adjoining the facility; 13. a review of the facilities quality assurance program to
ensure it exists and is maintained, including quality control
testing records; and
14. recommendations regarding the need for a follow-up
survey.

36 Safety Code 35
6.0 Disposal of X-ray Equipment
When X-ray equipment is considered for disposal, an
assessment should be made as to whether the equipment can
be refurbished and/or recycled. Communication with the
manufacturer or supplier of the equipment should be made as
to whether the equipment or components of the equipment can
be recycled or returned. Once the decision has been made to
dispose of X-ray equipment, an assessment must be made to
determine if any equipment components contain hazardous
materials. For example the X-ray tube may contain polychlo-
rinated biphenyls (PCBs) and lead may be present in the
X-ray tube housing. To ensure equipment is not unsafely
operated after disposal, it should be made inoperable before
disposing. The cables that power the equipment and other
electrical connections should be disconnected and removed. It
is recommended that radiological facilities, under provincial
or territorial jurisdiction contact the responsible agency in their
respective province or territory for further information. A list-
ing of these responsible agencies is provided in Appendix V.

Safety Code 35 37
Section C:
Quality Assurance Program
1.2 Costs-Benefits of the
Quality Assurance Program
1.0 Introduction
The initial implementation and the general operation of a qual-
All radiological facilities must develop and maintain an effec- ity assurance program will involve cost in both money and
tive quality assurance program. Quality assurance in radiol- time from staff. However, savings from the operation of the
ogy is defined as the planned and organized actions necessary program will offset some of these costs. For some facilities,
to provide adequate confidence that the X-ray equipment and there may be a reduction in the overall operating costs.
its related components reliably produce diagnostic informa-
tion of satisfactory quality with minimum doses to the patients 1.2.1 Costs of Quality Assurance Program
and staff. A quality assurance program includes quality control Some of the costs associated to the quality assurance program
procedures for the monitoring and testing of X-ray equipment are as follow:
and related components, and administrative methodologies to
ensure that monitoring, evaluation and corrective actions are 1. Personnel—The staff will be required to perform new
properly performed. The owner of an X-ray facility has the duties, which include generating test images for the X-ray
responsibility of establishing a quality assurance program equipment and record keeping.
which examines all practices of the facility which effect: 2. Test Equipment—Test equipment to perform quality
1. Information Quality—to ensure all diagnostic informa- control tests, such as phantoms, will be required. However,
tion produced provide for accurate clinical assessment; the cost of such equipment is small compared to the cost of
the X-ray imaging unit and it may be used for several X-ray
2. Clinical Efficiency—to ensure all steps leading to accu- systems. It would not be necessary to purchase some of the
rate diagnosis and intervention are taken and the information test equipment if the facility decides to have some of the qual-
is made available in a timely fashion to the patient’s physicians ity control tests performed by an external organization or
or primary medical professionals; and individual, who would then be responsible for providing their
3. Patient Dose—to ensure that the X-ray examination own test equipment.
is performed with the lowest possible radiation dose to the 3. Test Images—For film-based systems, and CR and DR
patient consistent with clinical imaging requirements. systems using laser printers, 2 to 5% of films used by a
facility may be required for the performance of sensitometry,
phantom imaging, equipment and test imaging.
1.1 Goals of the Quality
4. External Organizations—If the facility does not have
Assurance Program the capacity to perform internally all quality control tests, it
The ultimate goal of a quality assurance program is to ensure may choose to contract an external organization or individual
accurate and timely diagnosis and treatment at the minimum to perform some of these tests and equipment assessments. In
dose to the patient and staff. In order to have a successful qual- addition, the facility may retain the service of a medical physi-
ity assurance program it is essential that equipment is in proper cist as an advisor during implementation and for consultation
working condition and all staff members understand the goals during operation of the facility.
of the program and are committed to the implementation of
the program through full participation. 1.2.2 Benefits of Quality Assurance Program
In addition to improved diagnostic quality some of the savings
Information obtained from X-ray equipment must be of utmost associated with the quality assurance program are as follow:
quality to ensure accurate diagnosis and treatment. If critical 1. Film and Processing Chemicals—For film-based systems,
elements are missing or artifacts are added to images, the and CR and DR systems using laser printers, a decrease in the
image is considered to be of poor quality. The consequence of number of retakes may result in the reduction in the number of
poor quality diagnostic information may be incorrect diagno- films and processing chemicals used.
sis resulting in repeat radiographic procedures, unnecessary
radiation doses to the patient, delayed or improper patient 2. Equipment—The reduction in the number of retakes will
treatment and increased cost. lead to a reduction in workloads which in turn will put less
stress on X-ray equipment and image processors. Problems

38 Safety Code 35
with equipment may be diagnosed earlier before more serious iii) Policies for Minimizing Radiation Exposure to Patients
and costly problems occur thus reducing down time and  Policy for carrying out X-ray examinations.
equipment service costs.
 Policy for the radiological examination of
3. Patient Flow—The reduction in the number of repeats, pregnant patients.
and better image quality will allow efficient use of time for
both responsible users and the X-ray equipment operators.  Policy for the use of protective devices and
This will result in better predictability of scheduling and radiation protection equipment.
possibly greater patient throughput.  Policy for patient positioning (positioning
manual).
 Policy for exposure loading factors (technique
1.3 Implementation of charts).
Quality Assurance Program  Policy for the quality acceptance of diagnostic
radiograms.
The implementation of a quality assurance program need not
be complicated. It consists in establishing quality control  Policy for a reject analysis of radiographic
procedures for the equipment along with an administrative images.
methodology to ensure that monitoring, evaluation and iv) Guidelines for Equipment Quality Control (QC) Testing
corrective actions are properly performed.
 Guidelines listing all X-ray equipment and
system components to be tested.
1.3.1 Policies and Guidelines Development
 Guidelines for all equipment parameters to be
One useful step is to develop a series of policies and guide-
measured and the frequency of monitoring
lines where various issues are addressed. The following list
(schedule) for each X-ray system and system
presents some of these policies and guidelines. Each facility
component.
may require different sets of policies and guidelines depend-
ing on the type of work being performed and the organizational  Guidelines for the performance standards for
structure of the facility. These policies should be established by each equipment tested and the specific per-
management with participation from staff. It is recommended formance tolerance limits expected for each
that all safety policies, procedures and processes be reviewed QC test.
by a Joint Health and Safety Committee. The policies should  Guidelines for the measurement of each
be present in the Quality Assurance (QA) manual. The parameter and recording of the data.
following information should be readily available to radiology  Guidelines to evaluate the test data and to take
staff: the corrective action necessary to maintain
i) Radiology Personnel equipment optimum performance.
 A list of staff and an outline of their duties,  Guidelines for patient exposure measurements
authority and responsibilities. (ESEs, DRLs).
ii) Policies for Minimizing Radiation Exposure to X-ray  Guidelines for the calibration and maintenance
Operators and Staff of radiation measuring equipment and other
 Policy for minimizing exposure to pregnant test equipment.
workers. v) Policies for the Acquisition of New X-ray Imaging
 Policy for holding patients. Equipment
 Policy for the presence of individuals in the  Policy for a needs analysis.
X-ray room during procedures.  Policy for equipment specification writing.
 Policy for training/orientation program for  Policy for equipment acceptance testing.
X-ray equipment operators.
 Policy for equipment appraisal and replace-
 Policy for the proper use and maintenance of
ment.
X-ray equipment.
vi) Policy for Record Keeping
 Policy for personnel radiation dosimetry
monitoring.  Policy for the review of the QA Program.
 Policy for the use of protective devices and  Policy for the review of the QC Procedures.
radiation protection equipment.  Policy for the retention of records (patient
 Policy for the maintenance and testing of information, QC test results, survey reports,
radiation protection devices and equipment. personal dosimetry records).

Safety Code 35 39
1.3.2 Establishment of Quality Control Procedures of the quality assurance program. It is essential that the level
The following four steps must be included for the establish- of responsibilities and involvement of the owner and staff be
ment of quality control procedures: clearly identified, communicated and understood.
1. Equipment Operation—It is essential that the X-ray 2. Record Keeping—It is essential that measurements and
equipment and image processing equipment function properly information gathered for the quality assurance program is
before a quality assurance program is implemented. Manu- clearly documented and readily available for evaluation. As far
facturers and vendors should provide proper operating char- as practicable, recorded data should be indicated as data points
acteristics for their equipment. For film-based systems, films on a control chart for each day the measurement is made. For
and processing must meet manufacturers’ speed and contrast example, it includes the densitometric results of the sensito-
values. For CR and DR systems, the imaging system must be metric film strips, and the charting of temperature for the film
properly calibrated with the X-ray systems. This may involve processor. In this form, trends can be more easily detected. A
replacement, repair, upgrading or calibration of the equipment. log book or other easily identifiable method of recording must
be used.
2. Baseline Performance—Baseline performance values of
X-ray equipment and image processing system must be estab- 3. Evaluation of Data—Recorded data should be evaluated
lished after verifying that the equipment functions properly. immediately and necessary actions taken.
This baseline performance will be used to diagnose any 4. Limits of Acceptability of Data—Upper and lower limits
changes in equipment performance. It is important to keep of acceptability of recorded data must be determined and
records of equipment operation data and baseline performance documented. When these limits are reached, corrective
measurements. These records will be needed to diagnose any actions must be taken. For example, they can be the range of
changes in image quality. Baselines values must be determined acceptable temperatures for the film processor. These limits
when new equipment is introduced into the facility, when should be set such that they are just within the range allow-
there are changes in components which effect image quality able before diagnostically significant image changes are
and patient dose and also when testing equipment is changed. evident. They should not be so restrictive that they
3. Reference Test Image—To evaluate image quality a refer- exceed the capability of the equipment, or that frequent cor-
ence test image is needed. This reference test image is made by rective actions are taken without any evidence of problems.
using the X-ray equipment, image processing system and a These limits should be reviewed from time to time, especially
quality control phantom and will be used for comparison of when major components of the X-ray system are replaced or
quality control test images. repaired.
4. Result Evaluation and Action Levels—An effective qual- 5. Testing frequency—Testing frequency must be such that a
ity control monitoring program includes not only a routine balance is reached between the cost of testing, disruption to
quality control testing schedule, data recording and record the operation of the facility and the maintenance of quality.
keeping, but also test result evaluation, such as determination The frequency of testing should be increased if the equipment
of acceptable or unacceptable limits of equipment operation exhibits significant changes between scheduled quality con-
coupled with a list of corrective actions that may be required. trol tests, or if the equipment is used for exceptionally high
A set of limits should be established which indicates a level volume of procedures. Additional testing should be performed
of operation outside of which the system or the function should if the results of testing fall outside of limits of acceptability
be closely monitored but where no immediate action is re- for the tests, or after any corrective actions are made. Equip-
quired. Another set of limits should also be established where ment must be retested after service to any part which may
immediate remedial action must be taken. affect the image density, image quality or radiation output from
the X-ray tube. The quality control program should not be dis-
1.3.3 Establishment of Administrative Procedures continued if the results indicate relatively stable equipment
performance. The purpose of a quality control program is
The following administrative procedures must be included in to control quality, and periodic measurement of equipment
the establishment of an effective quality assurance program. performance is essential.
1. Responsibility—Although the owner of the facility is 6. Corrective Actions—There must be established repair and
ultimately responsible for the implementation and operation calibration procedures to deal with significant problems. A de-
of the quality assurance program, to obtain the optimal level of cision tree system should be developed to provide guidance to
radiation safety and quality diagnostic information, it is im- deal with events such as equipment failure and to deal with
perative that full cooperation exists among all concerned par- circumstances when equipment performance deviates beyond
ties. Staff members may be assigned duties with regard to the set limits. A list of individuals having the authority to stop
equipment monitoring, record keeping and general operations operation of an X-ray unit should be established. The decision
tree should include the following steps:

40 Safety Code 35
 (i) repeat the test to confirm; The results from the acceptance testing should be used to
(ii) what to do if repeated test confirms performance set baseline values and acceptance limits on operational per-
failure; formance of the X-ray equipment. These baseline values and
limits are essential to the quality assurance program.
(iii) what to do if test fails only marginally;
(iv) what to do if test shows a history of failure; and
(v) what to do if test fails substantially. 2.1 Acceptance Testing Evaluation
Acceptance testing for radiographic, radioscopic and CT
equipment should evaluate at least the following items below.
Not all equipment will be subject to the full set of tests. The
2.0 Acceptance Testing type of equipment and its configuration will dictate the sets of
Acceptance testing is a process to verify compliance with the tests to be performed. More detailed information on accept-
performance specifications of the X-ray equipment as written ance testing on radiographic, radioscopic and CT equipment is
in the purchase contract and that the equipment performance available from the International Electrotechnical Commission
complies with federal and provincial or territorial regulations. (IEC 1999), (IEC 2004).
It is recommended that acceptance testing be performed by a
medical physicist, or other individuals, with knowledge of the
particular type of X-ray equipment and the relevant regula-
tions prior to any clinical use of the equipment. The owner
may wish to have acceptance testing performed by an individ-
ual or organization independent of the manufacturer.

Acceptance testing of a medical X-ray system includes

several major steps. They are:
1. the verification that delivered components or systems
correspond to what was ordered;
2. the verification of the system mechanical integrity and
stability, including safety mechanisms, automatic patient
release, power drives, interlocks;
3. the verification of electrical installation, including elec-
trical safety and power line fluctuation;
4. the verification of X-ray performance; and
5. the verification of imaging or diagnostic performance.

Safety Code 35 41
Table 10: Acceptance Testing for Radiological Equipment

Items Under Evaluation for Film-based CR DR Radioscopic CT

Acceptance Testing System System System System System
1.0 Identification
1.1 Initial Inspection and Inventory X X X X X
1.2 Inspection of Documentation X X X X X
2.0 Visual and Functional Texts
2.1 Mechanical Properties X X X X X
2.2 Safety Systems X X X X X
3.0 Performance Evaluation (X-ray Generator)
3.1 X-ray Tube Voltage X X X X X
3.2 Current Time Product X X X
3.3 Loading Time X X X
3.4 Radioscopic Timer and Chronometer X
3.5 Beam Limitation and Indication X X X X X
3.6 X-ray Beam Filtration X X X X
3.7 Automatic Exposure Control X X X
3.8 Automatic Intensity Control X
3.9 Radiation Output X X X X
3.10 Maximum Air Kerma Rate X
3.11 Phantom (Entrance) Dose (Rate) X X X X X
4.0 Performance Evaluation (Image Receptor)
4.1 Exposure Index X X
4.2 Dynamic Range X X
4.3 Spatial Resolution X X X X X
4.4 Contrast Detectability X X X X X
4.5 Uniformity X X X
4.6 Artifacts X X X X X
4.7 Digital Detector Residual Image X X
4.8 Noise X X X
4.9 Modulation Transfer Function X X
4.10 Mean CT Numbers (calibration and linearity) X
4.11 Tomographic Section Thickness X
4.12 Axial Patient Positioning Accuracy X
4.13 Positioning of Patient Support X

42 Safety Code 35
 to the full set of tests listed in the following sections. For
example, for film-based systems, the evaluation of noise is not
3.0 Quality Control Testing necessary since this item is for the evaluation of digital
systems. The type of imaging system, whether film-based, CR,
Procedures and Equipment DR, radioscopic or CT, to which the quality control tests apply
Quality control testing must be carried out during routine is identified. Note that both radiographic and radioscopic
operation of a radiological facility. This section sets out the re- imaging equipment employing CR and DR digital image
quired and recommended quality control tests, the associated acquisition technologies must perform the required tests listed
test equipment and testing frequencies. for these systems. Alternative tests can be performed in place
of those specified if it can be shown that the test is capable of
Quality control testing of a medical X-ray system includes verifying the necessary parameter or performance.
several major steps. They are:
1. the verification of the system mechanical integrity and
stability, including safety mechanisms, automatic patient
3.1 Daily Quality Control Testing
release, power drives, interlocks; 3.1.1 Quality Control Tests List
2. the verification of the performance of ancillary equipment Daily quality control tests are listed in Table 11. The imaging
such as film processors and display units; systems to which the tests are applicable, and the test numbers
3. the verification of X-ray performance; and corresponding to those in section 3.1.2, are provided.
4. the verification of imaging or diagnostic performance,
including assessments of dose. 3.1.2 Daily Quality Control Tests
Daily Quality Control Tests. Daily Quality Control tests must
Test equipment required to perform daily to monthly quality be performed at the beginning of each day before commenc-
control tests, must be readily available to the individuals ing patient examinations.
responsible for performing these tests. All test equipment must D1. Equipment Warm-up—The manufacturer’s recommended
be calibrated and verified to be operating accurately. Individ- warm up procedure must be followed. The warm up pro-
uals performing quality control tests must be trained in the cedure must be repeated if the equipment is left idle for an
proper operation of the test equipment and in performing the extended period of time. It is important to note that all
tests. components of the imaging system which are routinely
used must be warmed up, including computer display
In the following sections, the descriptive text for each test devices and printers.
indicates whether performance of the test is required or
recommended. In addition, not all equipment will be subject

Table 11: Daily Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Daily Quality Control Tests
Equipment Warm-up D1 D1 D1 D1 D1
Meters Operation D2 D2 D2 D2 D2
Equipment Conditions D3 D3 D3 D3 D3
System Movements D4
Darkroom Cleanliness D5 D5
Film Processor Function D6 D6
Overall Visual Assessment of Electronic Display Devices D7 D7 D7 D7

Safety Code 35 43
D2. Meters Operation—Meters and visual and audible iii) Sensitometric strip processing must be performed
indicators should be checked for proper function. in order to monitor the performance of the image
D3. Equipment Conditions—X-ray equipment conditions processing system.
should be visually inspected for loose or broken compo- - The base plus fog must be within + 0.05 of the
nents and cleanliness. The X-ray source assembly should established operating level.
be checked for motion or vibration during operation. - The mid-density must be within ± 0.15 of the
Visual inspection should also be conducted of all other established operating level.
components of the imaging systems.
- The density difference must be within ± 0.15 of
D4. System Movement—System movement should be the established operating level.
checked for proper function. For systems where the X-ray
source is below the table, verify the performance of the D7. Overall Visual Assessment of Electronic Display
power assist and locks by moving the tower in all direc- Devices—The performance of electronic display devices
tions. For systems where the X-ray source is above the used for interpretation of clinical images must be as-
table, verify the motion of the X-ray tube assembly. sessed. Displaying the image of a test pattern, an assess-
ment must be made of the general image quality and for
D5. Darkroom Cleanliness—In order to maintain the cleanli- the presence of artifacts. The SMPTE or the TG18-QC
ness of the darkroom all working surfaces, tops of coun- test patterns can be used for this test and should be
ters and the floor should be cleaned daily. Dust and debris displayed using the software routinely used to display
can more easily be seen using a UV-B lamp. clinical images. It is recommended that the test pattern
D6. Film Processor Function—Film processor function must image be viewed from a distance of 30 cm from the front
be evaluated every morning before performing clinical of the display device. The results of the assessment must
examinations, after the processor has been turned on and be within established limits.
has reached the required development temperature; and at
other times as required, such as after a replenishment rate 3.1.3 Daily Quality Control Test Equipment
change. Facilities operating spotfilm equipment must also Test equipment for the daily quality control testing are listed
perform the following quality control tests on the film pro- in Table 12.
cessing system.
i) The film processing solution levels must be
checked to ensure agreement with the manufactur- 3.2 Weekly Quality Control Testing
ers’ recommended baseline levels for the particular
processor and film type, for the given number of 3.2.1 Quality Control Tests List
films processed daily. Weekly quality control tests are listed in Table 13. The
ii) The displayed processor temperature must be imaging systems to which the tests are applicable, and the test
checked to ensure agreement with the manufactur- numbers corresponding to those in section 3.2.2, are provided.
ers’ recommended baseline level for the particular
processor and film used.

Table 12: Daily Quality Control Test Equipment

Item Equipment Systems Reference

Phantom FS, CR, DR,
1 D1
(if needed for manufacturer’s recommended warm up procedure) RA, SF, CT

2 Ultraviolet Light FS, SF D5

Sensitometer
(21 steps optical attenuator with densities ranging from approximately 0.00 to 4.80 in steps of 0.15)
3 Accuracy: ± 0.02 log exposure units FS, SF D6
Reproducibility: ± 0.02 log exposure units
Densitometer
4 Accuracy: ± 0.02 O.D. at 1.0 O.D. FS, SF D6
Reproducibility: ± 0.01 O.D. at 1.0 O.D.
Test Pattern Image CR, DR,
5 D7
(ex.: SMPTE or TG18-QC) RA, CT

Note: FS: Film Screen, CR: Computed Radiography, DR: Digital Radiography, RA: Radioscopy, SF: Spotfilm, CT: Computed Tomography

44 Safety Code 35
Table 13: Weekly Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Weekly Quality Control Tests
Visual Inspection of Cleanliness of Imaging Systems W1 W1 W1 W1 W1
Viewboxes Condition W2 W2 W2 W2 W2
Laser Film Printer Operation W3 W3 W3 W3
CT Number Accuracy W4
CT Noise W5
CT Uniformity W6
Digital Subtraction Angiography System Performance W7

3.2.2 Weekly Quality Control Tests interest for the particular application should be used for
this test. It is recommended that this test be performed
W1. Visual Inspection of Cleanliness of Imaging Systems— at two CT conditions of operation, one representing a
Imaging systems must be inspected for dust and dirt on typical axial head scan and one representing a typical
or near the image reception area where they may nega- axial body scan.
tively affect image quality. For CR systems, the imaging
plates must be inspected. The imaging plate loading and W5. CT Noise—A measurement of CT noise must be made.
unloading mechanism must be cleaned and lubricated if Noise is given by the variation of CT numbers from a
necessary. The image receptors for direct-capture sys- mean value in a defined area in the image of a uniform
tems must be kept clean of dust, dirt and other items phantom. Its magnitude is equal to the standard devia-
which may come into contact with them. Laser scanning tion of the CT number values within the region of inter-
digitizers must also be checked for cleanliness. est. For noise evaluation, the diameter of the region of
interest should represent 40% of the diameter of the uni-
W2. Viewboxes Condition—Viewboxes must be inspected form phantom image. Noise can be quantified in HU or
visually for cleanliness, viewing area discolouration and expressed as a percentage of the linear attenuation
improper illumination. coefficient for water (see section B2.5.5). The noise in
W3. Laser Film Printer Operation—The quality of images a CT system must not deviate from the established base-
obtained from the laser film printer must be checked. line value by more than ± 10% or 0.2 HU, whichever is
Depending on the system, this may or may not require larger. The established baseline noise levels in a CT sys-
using pre-established window and level settings on the tem should not deviate from the manufacturer specified
display. Ensure that the viewbox used to assess printed noise value by more than ± 15%. It is recommended that
films has sufficient luminance. The SMPTE, TG18-QC this test be performed at two CT conditions of opera-
and TG18-PQC test patterns should be used. A hard- tion, one representing a typical axial head scan and one
copy image of the test pattern must meet the following representing a typical axial body scan.
criteria: W6. CT Uniformity—Uniformity is defined as the consis-
(i) the 5% patch must be just visible inside of the 0% tency of the CT numbers of an image of a homogeneous
patch, material across the scan field. Uniformity is calculated
(ii) the 95% patch must be just visible inside the 100% using the following equation:
patch,
∣(CTm,c) - (CTm,p)∣
(iii) no geometrical distortion upon visual inspection ,
(iv) no artifacts upon visual inspection. where
W4. CT Number Accuracy—An evaluation of the accuracy CTm,c is the mean CT number in the centre of
of the CT number of water must be made. Using a the image,
uniform water phantom, the mean CT number of water CTm,p is the mean CT number at the periphery
and the standard deviation, within a large region of of the image.
interest, must remain within the established baseline and The mean CT number must be determined for 5 regions
acceptable limits of variation. The CT number for water of interest, one in the centre and 4 at the peripheries of
must be in the range of 0 ± 4HU. For quantitative CT the phantom. The diameter of each region of interest
application, a phantom containing the material of should represent 10% of the diameter of the phantom.

Safety Code 35 45
 The difference between the mean CT number at the 3.2.3 Weekly Quality Control Test Equipment
centre of the phantom and the periphery must not Test equipment for the weekly quality control testing are listed
exceed 2 HU from the established baseline values. The in Table 14.
baseline uniformity of the CT number for water must
not be greater than ± 5 HU from the centre of the phan-
tom to the periphery. It is recommended that this test be
3.3 Monthly Quality Control Testing
performed at two CT conditions of operation, one rep-
resenting a typical axial head scan and one representing 3.3.1 Quality Control Tests List
a typical axial body scan. Monthly quality control tests are listed in Table 15. The
W7. Digital Subtraction Angiography System Perform- imaging systems to which the tests are applicable, and the test
ance—Following equipment warm up and prior to numbers corresponding to those in section 3.3.2, are provided.
clinical use, the image quality of the DSA system should
be evaluated using a phantom containing image quality
test objects

Table 14: Weekly Quality Control Test Equipment

Item Equipment Systems Reference

CR, DR,
1 Test Pattern Image W3
RA, CT
W4, W5,
2 Water Filled Uniform Phantom CT
W6
3 Digital Subtraction Angiography Image Quality Phantom RA W7

Table 15: Monthly Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Monthly Quality Control Tests
Cassette, Screen, and Imaging Plate Cleaning M1 M1 M1
Darkroom Temperature and Humidity Conditions M2 M2
Darkroom Light Conditions M3 M3
Film Processor Operation M4 M4
Retake Analysis M5 M5 M5
Electronic Display Device Performance M6 M6 M6 M6 M6
Laser Film Printer Operation M7 M7 M7 M7 M7
CT Tomographic Section Thickness M8
Calibration of CT Number M9
CT Number Linearity M10

46 Safety Code 35
3.3.2 Monthly Quality Control Tests TG18 test pattern. For closed systems, where a suitable
test pattern is not available on the system, a test pattern
M1. Cassette, Screen and Imaging Plate Cleaning— generator equipped with the appropriate test patterns
Cassettes, screens and imaging plates must be cleaned must be utilized. Where a system does not have the
and inspected for damage. Manufacturer recommended capability to display an externally provided pattern, the
cleaners and cleaning procedures should be used. An manufacturer recommended quality control procedures
inspection for dust particles should be done with an must be followed. The quality control procedures and
ultraviolet light. Cassettes must be checked for cleanli- acceptance criteria recommended by the AAPM
ness, wear, warping, fatigue of foam compression (AAPM 2005) should be used.
material and closure mechanism, light leaks.
M7. Laser Film Printer Operation—The quality of images
M2. Darkroom Temperature and Humidity Conditions—A obtained from the laser film printer must be checked.
monthly check of the darkroom temperature and Depending on the system, this may or may not require
humidity should be conducted. The temperature should using pre-established window and level settings on the
be between 18∘C and 23∘C and the humidity between display. Ensure that the viewbox used to assess printed
40% and 60%. films has sufficient luminance. The SMPTE, TG18-QC
M3. Darkroom Light Conditions— A weekly visual test and TG18-PQC test patterns should be used. A hard-
must be performed in the darkroom to ensure the room copy image of the test pattern must meet the following
is light tight. Particular attention must be paid to the criteria:
door seal and the mounting of the film processor, if the i) the 5% patch must be just visible inside of the
film insertion to the processor is done through a wall. 0% patch,
The assessment of darkroom light conditions should be
made after a 10 to 15 minute period of adaptation to the ii) the 95% patch must be just visible inside the
dark conditions with safelights turned off. 100% patch,
M4. Film Processor Operation—Facilities performing spot- iii) the optical density of various patches (for example
film must also perform quality control tests on the film 0%, 10%, 40% and 90%) must be within accept-
processing system. able limits from the established baseline values, for
the particular film used at the facility.
i) The accuracy of the processor temperature display
must be checked against a non-mercury ther- iv) no geometrical distortion greater than ± 1 mm,
mometer. The processor developer temperature v) no artifacts upon visual inspection.
should be accurate to within 0.5∘C. M8. CT Tomographic Section Thickness—An evaluation
ii) The replenishment rate must be compared with the of the tomographic section thickness must be made.
manufacturers’ recommended baseline level for the Measurement of the tomographic section thickness are
particular processor and film type, for the given made with a test device containing one or two ramps
number of films processed daily and for the positioned at an angle to the scan plane. For nominal
method of processing. tomographic section thicknesses of 2 mm or more, the
iii) All processing solutions should be changed and measured tomographic section thickness must not vary
processor solution tanks cleaned. by more than ± 1 mm from the established baseline
tomographic section thickness. For nominal tomo-
iv) Fixer retention tests should be performed to ensure graphic section thicknesses of 2 mm to 1 mm, the meas-
fixer is adequately removed from processed films ured tomographic section thickness must not vary by
according to established baseline levels. more than ± 50% from the established baseline tomo-
M5. Retake Analysis—Facilities must maintain records of graphic section thickness. For nominal tomographic
every retake, including the reason for the retake along section thicknesses of less than 1 mm, the measured
with any corrective actions. An analysis must be done of tomographic section thickness must not vary by more
the retake records to identify and correct any trends or than ± 0.5 mm from the established baseline tomo-
repeated errors. The retake rate should be less than 5%, graphic section thickness. For multislice CT equipment,
not including quality control films. If images contain this test must be performed for both outer tomographic
some patient diagnostic information, they should be sections and one inner tomographic section. For helical
maintained in the patient file. scanning, a test device consisting of a thin disk or bead,
M6. Electronic Display Device Performance—The perform- mounted in a medium, should be used. The linear atten-
ance of all electronic display devices used to view uation coefficient should be equal to or greater than that
images from digital systems, as well as those obtained of aluminum so that the resulting signal-to-noise ratio is
through scanning of radiographic films, must be
checked using a test pattern such as the SMPTE or a

Safety Code 35 47
 high. Upon scanning of this test device, the tomographic numbers of the materials should be compared with the
section is defined as the full width at half maximum of nominal values provided by the phantom manufacturer
the sensitivity profile as a function of the z position. and with previously measured values. The measured
M9. Calibration of CT number—At all clinically used values must remain within established limits for the
voltage settings, the mean CT number and standard de- CT scanner.
viation should be measured. The mean CT number and
standard deviation should be calculated for a 2-3 cm2 3.3.3 Monthly Quality Control Tests Equipment
area of water and air in the reconstructed image. The Test equipment for the monthly quality control testing are
same location should be used each time this test is per- listed in Table 16.
formed. The CT number for water must be 0 ± 4 HU.
The CT number for air must be -1000 ± 10 HU.
M10. CT number linearity—At all clinically used voltage set- 3.4 Quarterly Quality Control Testing
tings, the CT number linearity should be assessed. The
3.4.1 Quality Control Tests List
CT number linearity should be assessed by scanning a
phantom containing uniform objects of known materials Quarterly quality control tests are listed in Table 17. The im-
with a wide range of CT numbers. The measured CT aging systems to which the tests are applicable, and the test
numbers corresponding to those in section 3.4.2, are provided.

Table 16: Monthly Quality Control Test Equipment

Item Equipment Systems Reference

1 Ultraviolet Light FS, SF M1
2 Hygrometer FS, SF M2
Thermometer (non-mercury)
3 FS, SF M2, M4
Accuracy: ± 0.3∘C Reproducibility: ± 0.1∘C
4 Fixer Retention Test Kit FS, SF M4
Test pattern(s) for evaluation of electronic display device performance and laser film printer FS, CR, DR,
5 M6, M7
(ex. SMPTE, TG18-QC, TG18-PQC) RA, SF, CT
Densitometer
Accuracy: ± 0.02 O.D. at 1.0 O.D. CR, DR, RA,
6 M7
CT
Reproducibility: ± 0.01 O.D. at 1.0 O.D.
FS, CR, DR,
7 Ruler M7
RA, SF, CT
8 Test device containing ramps, thin disk or beads CT M8
9 Water filled uniform phantom CT M9
10 Phantom with imbedded uniform objects of known materials CT M10

Table 17: Quarterly Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Quarterly Quality Control Tests
Collimator Operation Q1 Q1 Q1 Q1
Interlocks Q2 Q2 Q2 Q2 Q2
Table Angulation and Motion Q3
Compression Devices Operation Q4
Chronometer Operation Q5
Protective Devices Q6
Park Position Interrupt Q7
CT Patient Support Movement Q8
CT Spatial Resolution Q9
CT Low Contrast Detectability Q10

48 Safety Code 35
3.4.2 Quarterly Quality Control Tests Q9. CT Spatial Resolution—The spatial resolution must
be tested, with the CT conditions of operation of the
Q1. Collimator Operation—Using each collimating option, scanner, using one of the following three methods. The
a test should be performed to ensure smooth collimator recommended method of measuring the spatial resolu-
blade motion. If applicable, vary the SID to assure the tion is using the modulation transfer function curve,
collimator tracks (i.e., automatically maintain the field obtained from the Fourier transform of the point-spread
size) as the SID changes. function. The test device is a high contrast wire, typi-
Q2. Interlocks—If there are interlocks on the door(s), they cally 2 mm in diameter or less, placed in a tube of
must be tested to ensure that they prevent the X-ray minimally attenuating material. The measurement of the
equipment from producing radiation when the door 50% point and the 10% point of the MTF curve must be
is open. For radioscopic equipment, it must not be within 0.5 lp/cm or ± 15% of the established baseline
possible to activate the X-ray tube unless the entire value, whichever is greater.
radioscopic beam is intercepted by the image receptor. A quantitative measurement of modulation can be made
Q3. Table Angulation and Motion—The table should move using a bar pattern test device which contains line-pair
freely to the upright position and stop at the appropriate patterns of different spatial frequencies. Using region of
spot. The table angle indicator and the actual table angle interest measurements, individual points along the MTF
should coincide to within 2 degrees. curve can be obtained. When measurements are made
Q4. Compression Devices Operation—Check that available using a test object with line-pair patterns of varying
compression devices easily move in and out of the X-ray spatial frequency or by noting the spatial frequency at
beam and function correctly. which the measured modulation transfer function drops
to 5%, the limiting high contrast resolution should be
Q5. Chronometer Operation—The chronometer accuracy
5 line pairs per centimetre or more.
should be verified with a stopwatch.
An alternate method is through visual assessment using
Q6. Protective Devices for Radioscopic Equipment—A
a test device consisting of a repeated pattern of holes,
protective curtain or drape, of at least 0.25 mm lead
bars or lines. When measuring the limiting high contrast
equivalence at 100 kV, must be in place and move freely
resolution using a phantom for high contrast resolution
so that it can be placed between the patient and any per-
having sets of test objects of equal diameters and spac-
sonnel in the radioscopic room. Lead drapes should be
ing, the high contrast resolution must be 1 mm or less.
affixed to the image intensifier (under table systems) and
have no creases or gaps that may subject the operator to Q10. CT Low Contrast Detectability—Measurements should
unnecessary scatter radiation. If the unit is an under be made of the low contrast detectability to ensure it is
table radioscopic system, check that the shield covering within established limits. Low contrast detectability is
the cassette holder entrance during radioscopy is work- typically specified as the smallest sized object at a spec-
ing as intended. The shield should provide the equivalent ified contrast level to the background which can seen
protection of at least 0.5 mm of lead at 100 kV. in a particular phantom when imaged under specified
conditions. The phantom used for this test should have
Q7. Park Position Interrupt—When the image receptor is
objects with less than 1% or 10 HU contrast to the
in the parked position, it should not be possible to ener-
surrounding material. The limiting detectability should
gize the X-ray tube. This many be checked while wear-
be measured with the reconstruction algorithm of the
ing a lead apron and depressing the radioscopic
scanner which is routinely used, as well as other clini-
irradiation switch to see if the system is activated.
cally relevant reconstruction algorithms. The baseline
Q8. CT Patient Support Movement—The accuracy of the performance level must be stated for a given phantom at
patient support movement ensures that the desired vol- specific scan conditions, including radiation dose, view-
ume of the patient is scanned. This becomes important ing conditions, and visualization criteria. It should be
when performing contiguous scans where the scan in- noted that this visual test for establishing low contrast
terval equals the scan width to image an entire volume detectability is subjective since it depends on a number
of the patient. If the scan interval is larger than the scan of factors including the visual acuity of the observers
width, then gaps are present in the imaged volume. If and ambient lighting conditions.
the scan interval is smaller than the scan width, then the
scans will overlap. The measured patient support move- 3.4.3 Quarterly Quality Control Tests Equipment
ment must be within ± 1 mm of the intended movement
Test equipment for the quarterly quality control testing are
when the patient support moves both into and out of the
listed in Table 18.
gantry. To simulate the weight of the patient, a phantom
or other weights (not exceeding 135 kg) must be place
on the support when performing this test.

Safety Code 35 49
Table 18: Quarterly Quality Control Test Equipment

Item Equipment Systems Reference

1 Stopwatch RA Q5
Dosimeter
2 Accuracy: ± 5% RA Q6
Reproducibility: ± 1%
3 Weight (not exceeding 135 kg) CT Q8
4 Ruler CT Q8
5 Pre-packaged film (ex. “Ready Pack”) CT Q8
6 Needle (for puncturing holes in film) CT Q8
7 CT Spatial Resolution Test Device CT Q9
8 CT Spatial Resolution Test Device CT Q10

3.5 Semi-Annual Quality Control Testing ii) Isocentre Alignment and Sagittal and Coronal
Scan Localization Lights—Place a thin absorber
3.5.1 Quality Control Tests List
(pencil) centred in the tomographic plane at the in-
Semi-annual quality control tests are listed in Table 19. The tersection of the sagittal and coronal positioning
imaging systems to which the tests are applicable, and the test light fields. The intersection of the sagittal and
numbers corresponding to those in section 3.5.2, are provided. coronal scan localization lights must indicate the
centre of the field of view. The midline of the table
3.5.2 Semi-Annual Quality Control Tests should be coincident with the sagittal scan align-
SY1. CT Laser Light Accuracy—Laser light accuracy must ment light. The results must be within the manu-
be determined for both axial scan localization lights, facturer’s recommended values and tolerances. A
which indicate the location of the radiation beam rela- limit of ± 5 mm should be achievable.
tive to the external anatomical structures of the patient, SY2. CT Accuracy of Automatic Positioning of Tomographic
and the sagittal and coronal scan localization lights, Plane (using the scanned projection radiograph/scout
which centre the anatomic structure of interest in the localization)—The location of the scan plane prescribed
scan field of view. by using the scanned projection radiograph must be
i) Axial Scan Localization Lights—Axial scan local- within ± 2 mm of the actual scan plane.
ization light accuracy is tested either by imaging a SY3. CT Accuracy of Gantry Tilt—The accuracy of the
thin wire (approximately 1 mm diameter) or by indicated CT gantry tilt should be verified. When per-
using a needle to puncture holes in film at the forming non-orthogonal scans, it is important to ensure
positions of the laser lights and exposing the film that the physical tilt of the gantry corresponds to the
using the smallest available scan width. The dif- tilt angle indicated on the CT display. This is generally
ference between the exposed areas on the film done by exposing film placed upright and parallel to
and the locations of the pin pricks must be less than the sagittal laser at various gantry tilt angles. At least
± 2 mm. 3 irradiations need to be made on the film: no tilt

Table 19: Semi-annual Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Semi-annual Quality Control Tests
CT Laser Light Accuracy SY1
CT Accuracy of Automatic Positioning of
Tomographic Plane SY2
(using the scanned projection radiograph)
CT Accuracy of Gantry Tilt SY3
CT Patient Dose SY4

50 Safety Code 35
 (0 degrees) and each of the extreme angles. The angles 3.6 Annual Quality Control Testing
measured on the film should correspond with the com-
puter display to within ± 3 degrees. 3.6.1 Quality Control Tests List
SY4. Patient Dose—The CTDI100 must be determined for Annual quality control tests are listed in Table 21. The imag-
both head and body scanning techniques, using the CT ing systems to which the tests are applicable, and the test
dosimetry phantom placed on the patient support with- numbers corresponding to those in section 3.6.2, are provided.
out any additional attenuating material present. For each
technique, the CTDI100 must be determined at the 3.6.2 Annual Quality Control Tests
centre and periphery of the phantom as well as in air Y1. Safelight Test—An evaluation must be made of the
using the manufacturer’s recommended techniques and effects of the safelight on film optical density. A film
setting. The values of CTDI100 are used to calculate
strip exposed to an optical density of 1.2 units must not
CTDIw which must be within ± 20% of the established
baseline values and the manufacturer’s specifications show an increase in optical density greater than
when a fixed technique is used. It is highly recom- 0.05 units in two minutes exposure to the darkroom light
mended to strive for an agreement with manufacturers’ environment. Facilities performing spotfilm must also
specification of ± 10%. This test should be performed by perform this quality control test.
a medical physicist. Y2. Screen/Film Contact—All cassettes used in the facility
must be tested for screen/film contact. Large areas of
3.5.3 Semi-annual Quality Control Tests Equipment poor contact that are not eliminated by screen cleaning
Test equipment for the semi-annual quality control testing are and remain in the same location during subsequent tests
listed in Table 20. should be replaced. Facilities performing spotfilm must
also perform this quality control test.

Table 20: Semi-annual Quality Control Test Equipment

Item Equipment Systems Reference

1 Thin wire CT SY1, SY2
2 Pre-packaged film (ex. “Ready Pack”) CT SY1, SY3
3 Sharp needle (for puncturing holes in film) CT SY1
4 Pencil CT SY1
5 Ruler CT SY1
6 Protractor CT SY3
CT Dosimetry Phantom—Head
7 Circular cylinder constructed of polymethyl methacrylate CT SY4
Density 1.19 ± 0.01gm/cm3, length 14 cm, diameter 16 cm
CT Dosimetry Phantom—Body
8 Circular cylinder constructed of polymethyl methacrylate CT SY4
Density 1.19 ± 0.01gm/cm3, length 14 cm, diameter 32 cm
9 Dosimeter and CT Dose Probes CT SY4

Safety Code 35 51
Table 21: Annual Quality Control Tests

Quality Control Procedures Film-based CR DR Radioscopic CT

Under Evaluation System System System System System
Annual Quality Control Tests
Safelight Test Y1 Y1
Film/Screen Contact Y2 Y2
Accuracy of Loading Factors Y3 Y3 Y3 Y3
Radiation Output Reproducibility Y4 Y4 Y4 Y4
Radiation Output Linearity Y5 Y5 Y5 Y5
X-ray Beam Filtration Y6 Y6 Y6 Y6
Automatic Exposure Control Y7 Y7 Y7 Y7
X-ray Field and Light Field Alignment Y8 Y8 Y8 Y8
X-ray Beam Collimation Y9 Y9 Y9 Y9
Grid Performance Y10 Y10 Y10 Y10
Response Function Y11 Y11
Exposure Index Y12 Y12
Dynamic Range Y13 Y13 Y13 Y13
Noise, Uniformity and Image Artifacts Y14 Y14
Spatial Resolution Y15 Y15 Y15 Y15
Contrast Detectability Y16 Y16 Y16 Y16
Digital Detector Residual Images Y17 Y17
Phantom Dose Measurements Y18 Y18 Y18 Y18
Typical Image Intensifier Air Kerma Rate Y19
Maximum Image Intensifier Air Kerma Rate Y20
Automatic Intensity Control Y21
Image Lag Y22
CT Number Dependence on Phantom Position Y23
CT Radiation Dose Profile Y24
CT Radiation Dose—Scout Localisation Image Y25
Viewboxes Y26 Y26 Y26 Y26 Y26
Electronic Display Device Performance Y27 Y27 Y27 Y27
Integrity of Protective Equipment Y28 Y28 Y28 Y28 Y28
General Preventive Maintenance Y29 Y29 Y29 Y29 Y29

Y3. Accuracy of Loading Factors—For any combination of the coefficient of variation of any ten consecutive irra-
loading factors, the X-ray tube voltage must not deviate diation measurements, taken at the same source to
from the selected value, by more than 10%, the loading detector distance within a time period of one hour, is
time must not deviate from the selected value by more no greater than 0.05, and each of the ten irradiation
than (10% + 1 ms), the X-ray tube current, must not measurements is within 15% of the mean value of the
deviate from the selected by more than 20%, and the ten measurements
current-time product must not deviate from the selected Y5. Radiation Output Linearity—For any pre-selected value
value by more than (10% + 0.2 mAs). of X-ray tube voltage, the quotient of the average air
Y4. Radiation Output Reproducibility—The X-ray tube kerma measurement divided by the indicated current
radiation output shall be high enough to minimize irra- time product obtained at two settings of X-ray tube
diation time to eliminate perceptible motion artifacts. current or X-ray tube current-time product must not
For any combination of operating loading parameters, differ by more than 0.10 times their sum, that is,

52 Safety Code 35
 . ( X1 + X 2 )
edges of the visually defined field with the edges of the
X 1 − X 2 ≤ 010 X-ray field must not exceed 2% of the focal spot to
image receptor distance.
where X1 and X2 are average air kermas (exposures) per
Y9. X-ray Beam Collimation—(a) An evaluation of the
current time product. The values of X1 and X2 must be
beam limiting device must be made to ensure that the
determined at
equipment is capable of aligning the centre of the X-ray
(a) if the X-ray tube current is selected in discrete field with the centre of the image reception area to
steps, any two consecutive X-ray tube current within 2% of the focal spot to image receptor distance.
settings; (b) Radiographic X-ray equipment that has a positive
(b) if the X-ray tube current selection is continuous, beam limiting system must prevent the emission of
any two X-ray tube current settings that differ by a X-rays until the beam limiting device is adjusted so that
factor of 2 or less; i) the dimensions of the X-ray field do not exceed
(c) if the current time product is selected in discrete those of the image reception area, or the selected
steps, any two consecutive current time product portion of that area, by more than 3% of the focal
settings; or spot to image receptor distance, and
(d) if the current time product selection is continuous, ii) the sum of the absolute values of the differences in
any two current time product settings that differ by the dimensions of the X-ray field and the image
a factor of 2 or less. reception area, or the selected portion of that area,
Y6. X-ray Beam Filtration—The first half-value layer of does not exceed 4% of the focal spot to image
aluminum must be measured. The measured values receptor distance.
must not be less than the values shown in Table 8 in sub- (c) Radioscopic equipment equipped with a spotfilm
section B2.5.1 for a selected X-ray tube voltage. device must have a mechanism that, when the X-ray
Y7. Automatic Exposure Control—For film-based systems, beam axis is perpendicular to the image reception plane,
the automatic exposure control must be evaluated to permits the perimeter of the X-ray field to be aligned
ensure it performs in such a way that the variation in op- with that of the selected portion of the image reception
tical density in the resultant radiograms does not exceed area so that
the value of i) the dimensions of the X-ray field differ from the
i) 0.15 when the X-ray tube voltage is variable and corresponding dimensions of the image reception
the thickness of the irradiated object is constant, area by a distance that does not exceed 3% of the
focal spot to image receptor distance, and
ii) 0.20 when the thickness of the irradiated object is
variable and the X-ray tube voltage is constant, ii) the sum of the absolute values of the differences in
the dimensions between the X-ray field size and
iii) 0.20 when the thickness of the irradiated object and the image reception area does not exceed 4% of the
the X-ray tube voltage are both variable, and focal spot to image receptor distance.
iv) 0.10 when the thickness of the irradiated object and Y10. Grid Performance—Grid performance, including move-
the X-ray tube voltage are both constant. ment and uniformity, must be checked annually.
For digital systems, the performance of the automatic Y11. Response Function—For digital X-ray imaging systems,
exposure control must be assessed according to the the response function of the detector should be assessed.
manufacturer’s procedures and must be within the man- The manufacturer specified relationship between the
ufacturer’s specifications. It is recommended that the system response (mean pixel value in a standard region
automatic exposure control should perform in such a of interest) and exposure to the image receptor, over a
way that the variation in the mean linearized data on a range of tube loadings, should be confirmed to be within
constant region of interest does not exceed 20% for established limits. The manufacturer’s recommended
constant X-ray tube voltage and constant thickness of testing procedure should be followed.
the irradiated object, when the X-ray system is operated
in conditions representative of the typical clinical use. Y12. Exposure Index—For digital X-ray imaging systems,
Compliance is checked by ensuring that the ratio of the the accuracy and reproducibility of the exposure index,
highest and the lowest measured values is less than or as a function of the dose to the image receptor, must be
equal to 1.2 or within the manufacturer’s specifications. evaluated. The manufacturer’s recommended testing
procedure must be followed and the results must be
Y8. Light Field and X-ray Field Alignment—The alignment within established limits.
of the light localizer, designed to define the outline of
the X-ray field, with the X-ray field must be verified. In
the plane of the image receptor, the misalignment, of the

Safety Code 35 53
Y13. Dynamic Range—For film screen systems, a high Y17. Digital Detector Residual Image—There must not be
purity step wedge should be used to monitor the per- any visible residual image from a previous exposure.
formance of the X-ray generator. When using a 11-step The manufacturer’s recommended test procedure should
wedge, the acceptable variation in film density should be followed.
be ± 1 step from the established baseline density, or Y18. Phantom Dose Measurements—Entrance skin air kerma
when using a 21-step wedge, the acceptable variation in measurement for frequently performed examinations
film density should be ± 2 steps from the established must be within established limits. Measurements should
baseline density. For digital systems, the dynamic range be performed using the equipment geometry and load-
is a measure of the maximum difference in attenuation ing conditions representative of those used clinically.
that the system can simultaneously image, without loss Dose values obtained should be used for the annual
of information due to saturation of pixels. A test object review of the facilities Diagnostic Reference values.
consisting of an attenuating plate terminated with a step
wedge of 12 steps should be used. The number of non Y19. Typical Air Kerma Rate of Radioscopic Equipment—
saturated steps or the thickness of the smallest non Using a uniform phantom place on the patient support,
saturated step should be within established limits. measurements of the typical entrance air kerma rate, in-
cluding backscatter, should be made for all geometries
Y14.Noise, Uniformity and Image Artifacts—An assessment and modes of operation used clinically. The values
must be made of noise, uniformity and image artifacts. should be within established levels.
The Signal-to-Noise Ratio (SNR) should be calculated
by measuring the mean pixel value and standard Y20. Maximum Air Kerma Rate of Radioscopic Equip-
deviation in a region of interest within the image. The ment—Radioscopic equipment, other than when record-
standard deviation of signal values should be determined ing images, must not operate at any combination of
for three different locations, at the centre, at the top, and X-ray tube voltage and X-ray tube current that results
at the side of the image. The size of the region of inter- in an air kerma rate that exceeds
est should equal approximately 10% of the area of the i) 50 mGy/min when the equipment is not fitted with
phantom. The test should be done using homogeneous an automatic intensity control,
phantoms having thicknesses representative of patient ii) 100 mGy/min when the equipment is fitted with an
thickness. The measured noise value must be within automatic intensity control, and
established limits. The uniformity of the signal across
iii) 150 mGy/min when the equipment is fitted with
the different regions of interest at the periphery and the
both an automatic intensity control and a high-
centre of the phantom must be within established limits.
level irradiation control when the latter is activated.
Images must be assessed to ensure that unacceptable
artifacts are not present. The image intensifier must be protected with sufficient
(approximately 6 mm) lead sheets when performing this
Y15. Spatial Resolution—An evaluation must be of the
test.
spatial resolution of the equipment. Spatial resolution is
the ability to resolve objects in a resultant image when Y21. Automatic Intensity Control—An evaluation must be
the difference in the attenuation between the objects and made of the automatic intensity control system of
the background is large compared to noise. The radioscopic systems. The automatic intensity control
manufacturer’s recommended test procedures must be system is designed to maintain the rate of the X-ray
followed. For each mode of operation, the spatial exposure to the image intensifier with changes in thick-
resolution must within established limits. ness and composition of the anatomical region being
imaged. Place a dosimeter between a homogenous
Y16. Contrast Detectability—An evaluation should be made
phantom and the X-ray source. Double the phantom
of contrast detectability. The contrast detectability is the
thickness and repeat the exposure. The exposure meas-
ability to resolve different objects from the background
urement should be approximately double the first
when the difference in attenuation between the objects
measurement.
and the background is small compared to noise. The
manufacturer’s recommended test procedures should be Y22. Image Lag—An evaluation of the image lag should be
followed. For each mode of operation, the contrast made to ensure the performance of the TV camera does
resolution should be within established limits. For DSA not cause unnecessary smearing of the radioscopic
applications, it is recommended to use a phantom with image. Radioscopic systems used for cardiac catheteri-
contrast levels representative of clinically used iodine zation and interventional procedures must have a high
contrast levels. frame rate to provide sufficient temporal resolution
required by such procedures. Viewing the image of a
rotating test tool, the radioscopic system should be able
to visualize a wire of diameter 0.013 inch or smaller.

54 Safety Code 35
 This test should be repeated using cine cameras and Y27. Electronic Display Device Performance—The perform-
digital recorders to ensure that these systems are ance of all electronic display devices used for the inter-
delivering optimal image quality. pretation of clinical images and guidance during
Y23. CT number dependence on phantom position—The CT interventional procedures must be verified using a test
number for water must not vary by more than ± 5 HU pattern such as the SMPTE or TG18 test patterns. For
when the position of a water filled phantom is varied closed systems, where a suitable test pattern is not
over clinically relevant positions on the patient support. available on the system, a test pattern generator
equipped with the appropriate test patterns must be uti-
Y24. CT Radiation Dose Profile—The collimation of the lized. Where a system does not have the capability to
radiation beam should be assessed to ensure it does not display an externally provided pattern, the manufacturer
exceed the prescribed scan width. Scan width is typi- recommended quality control procedures must be fol-
cally defined as the full width half maximum (FWHM) lowed. The annual quality control tests recommended
of the radiation dose profile. For each available scan by the American Association of Physicists in Medicine
width, the FWHM of the radiation dose profile should (AAPM, 2005), including test procedures and accept-
not exceed the prescribed scan width by more than man- ance criteria should be used. An evaluation should
ufacturer’s specifications. The FWHM of the radiation be made of geometric distortion, reflection, luminance
dose profile can be measured either directly from the response, luminance dependencies, resolution, noise,
density profile of the resultant film or computed from veiling glare and chromaticity. The display system must
the digital profile upon digitization of the image. be warmed up prior to testing and attention must be
Y25. CT Radiation Dose–Scan Projection Radiograph/Scout given to the ensure ambient light levels are appropriate
Localization Image—The dose delivered from a scout and representative of condition under which clinical
localization image, which is a scanned projection images are viewed. A viewing distance of 30 cm is
radiograph, must remain within ± 20% of the nominal recommended.
value. Changes in this dose can be indicative of prob- Y28. Integrity of Protective Equipment—All personnel’s pro-
lems with collimation or patient support movement. The tective equipment must be examined using radiographic
technique and loading factors used to obtain the scout or radioscopic equipment to ensure they are not defec-
localization image must be recorded, so that identical tive. Lead aprons where the total defective area is
test conditions can be used for subsequent tests. It is greater than 670 mm2 are not acceptable. Personnel pro-
recommended that this test be performed semi-annually, tective equipment having a defect in the vicinity of the
but must be performed at least annually. thyroid or the reproductive organs which is larger than
Y26. Viewboxes—All viewboxes must be tested for compli- the equivalent of a 5 mm diameter circle must not be
ance with the following requirements. Ensure all view- used. Personal judgement should be used when small
boxes have been turned on for a minimum of 30 minutes defects are located along the edges of the protective
before obtaining measurements. equipment and when defects are due to stitching of the
i) Luminance. Luminance is the amount of light equipment. All protective equipment, when not in use,
emitted or scattered by a surface. The view box should be stored in accordance to the manufacturers’
luminance should be at least 2,500 nits (cd/m2). recommendations.
ii) Light Output Uniformity. The light output from Y29. General Preventive Maintenance—Preventive mainte-
the viewboxes should be uniform to within 10%. nance of the X-ray equipment and accessories is
Measurements should not be made near the edges necessary to prolong the life of the equipment. An
of the viewbox (within 1 to 2 inches), where lumi- annual inspection must be conducted for structural
nance values may be quite low. integrity, cleanliness, ease of movement of all compo-
nents and any other procedures recommended by the
iii) Light Output Homogeneity. The light output
manufacturers.
homogeneity between a bank of viewboxes should
be uniform to within 20% of the mean.
3.6.3 Annual Quality Control Tests Equipment
iv) Ambient Light Control. The ambient light within
Test equipment for annual quality control testing are listed in
the reading room must be less than 50 lux. A value
Table 22.
of 5-10 lux is recommended.

Safety Code 35 55
Table 22: Annual Quality Control Test Equipment

Item Equipment Systems Reference

Densitometer
1 Accuracy: ± 0.02 O.D. at 1.0 O.D. FS, SF Y1, Y7, Y13
Reproducibility: ± 0.01 O.D. at 1.0 O.D.
2 Stopwatch FS, SF Y1
3 Film/screen contact test tool FS, SF Y2
Non-invasive X-ray tube voltage meter FS, CR
4 Y3
Accuracy: ± 1.5 kV Reproducibility: ± 0.5 kV DR, SF
Irradiation time meter FS, CR
5 Y3
Accuracy: ± 5% Reproducibility: ± 1% DR, SF
Current meter FS, CR,
6 Y3
Accuracy: ± 1% Reproducibility : < 0.5% DR, SF

Dosimeter Y4, Y5, Y6,

FS, CR, Y11, Y12,
7 Accuracy: ± 5% Reproducibility: ± 1%
DR, RA Y18, Y19,
CT dose probes - scout localization dose Y20, Y21, Y25
Aluminum filter (> 99.9% purity)
8 FS, CR, DR Y6, Y17
Accuracy: 1% thickness
Y7, Y10, Y11,
Multiple sheets of uniform, tissue equivalent attenuator FS, CR, DR, Y12, Y13, Y14,
9
(covering range of clinical patient thicknesses) RA, SF Y15, Y16, Y17,
Y19,Y21
FS, CR, DR,
10 Metallic markers Y8
RA, SF
FS, CR, DR,
11 Ruler Y8, Y9, Y28
RA, SF
FS, CR, DR,
12 X-ray Beam Alignment test tool Y9
RA, SF
FS, CR, DR,
13 Stepwedge Y13
RA, SF
Spatial Resolution test tool FS, CR, DR,
14 Y15
(specific for type of equipment) RA, SF
Contrast Detectability test tool FS, CR, DR,
15 Y16
(specific for type of equipment) RA, SF
FS, CR, DR,
16 Phantom for evaluation of Entrance Surface Dose Y18
RA, SF
17 6 mm lead sheet RA Y20
Rotatable spoke test tool pattern
18 RA Y22
(steel wires of diameter ranging from 0.005 inches to 0.022 inches, rotatable at 30 rpm)
19 Electric motor capable of producing 30 rpm RA Y22
20 Water filled uniform phantom CT Y23
21 Pre-packed film (ex. “Ready Pack”) CT Y24
22 Scanning Microdensitometer CT Y24
CT Dosimetry Phantom - Head
23 Circular cylinder constructed of polymethyl methacrylate CT Y25
Density 1.19 ± 0.01 gm/cm3, length 14 cm, diameter 16 cm
CT Dosimetry Phantom - Body
24 Circular cylinder constructed of polymethyl methacrylate CT Y25
Density 1.19 ± 0.01 gm/cm3, length 14 cm, diameter 32 cm
25 CT Dose Probes CT Y25
Light meter (for measurement of luminance and illuminance)
Accuracy: ± 10% FS, CR, DR,
26 Y26
SF, CT
Reproducibility: ± 5%
Test patterns (for evaluation of electronic display system) CR, DR, RA,
27 Y27
(ex. TG18 ) CT

56 Safety Code 35
Appendix I:
Dose Limits for Occupational Ionizing Radiation Exposures

For the purpose of this Safety Code, individuals may be I

classified in one of two categories: (1) radiation workers, Effective Dose = E + 20∑ ≤ 4 mSv
LAI
individuals who are occupationally exposed to X-rays and
where
(2) members of the public. The dose limits are given for both
categories in Table AI.1. These dose limits are based on the E is the portion of the effective dose, in millisievert
latest recommendations of the International Commission (a) received by a person from sources outside the
on Radiological Protection (ICRP) as specified in ICRP body; and
Publication 60 (ICRP, 1991). (b) received by and committed to the person from
sources inside the body, measured directly or from
Dose limits for radiation workers apply only to irradiation excreta,
resulting directly from their occupation and do not include
radiation exposure from other sources, such as medical diag- I is the activity in bequerel, of any radionuclide that is
nosis and background radiation. taken into the body, excluding the radon progeny and
the activity of other radionuclides accounted for in the
determination of E, and
Table AI.1: Annual Dose Limits
ALI, or annual limit on intake, is the activity, in bequerel,
Applicable Radiation Members of a radionuclide that will deliver an effective dose of
Body Organ Workers of the Public 20 mSv during the 50 year period after the radionuclide
or Tissue (mSv) (mSv) is taken into the body of a person 18 years or older or
Whole Body 20 1 during the period beginning at intake and ending at
Lens of the eye 150 15 age 70 after it is taken into the body of a person less than
18 years old.
Skin 500 50
Under the scope of this document, occupational exposures
Hands 500 50
to pregnant workers arise mainly from scattered
All other organs 500 50 X-radiation. In this case, the most effective method of moni-
toring exposures to the foetus, is to measure the equivalent
dose to the surface of the abdomen using a thermoluminescent
1. It is emphasized that any irradiation involves some degree dosimeter.
of risk and the levels suggested in this Appendix are maximum 4. For technologists-in-training and students, the recom-
values. All doses must be kept as low as reasonably achiev- mended dose limits for members of the public should apply.
able and any unnecessary radiation exposure must be avoided.
5. ICRP does not recommend different limits for individual
2. The ICRP does not recommend discrimination in the dose organs. For occupationally exposed workers, ICRP believes
limits between men and women of reproductive capacity, if that deterministic effects will be prevented by applying an
the dose is received at an approximately regular rate. equivalent dose limit of 500 mSv in a year to all tissues except
3. For occupationally exposed women, once pregnancy has the lens of the eye, for which it recommends a limit of
been declared, the foetus must be protected from X-ray expo- 150 mSv in a year.
sure for the remainder of the pregnancy. For women who are 6. For the skin, the equivalent dose is averaged over its
also occupationally exposed, an effective dose limit of 4 mSv whole area. In situations where deterministic effects are pos-
must be applied, for the remainder of the pregnancy, from all sible, the recommended equivalent dose limit for the skin is
sources of radiation. It is calculated as follows: 500 mSv and is averaged over areas of no more than 1 cm2.
This limit applies to the skin of the face and hands.
7. Some provincial or territorial jurisdictions may have
different dose limits for some workers. The appropriate
agency, listed in Appendix V, should be consulted to
determine the dose limits in effect in a particular jurisdiction.

Safety Code 35 57
Appendix II:
Shielding Information Guides

Table AII.1: Information to calculate shielding requirement for radiographic X-ray system

Information Required for Radiographic X-ray Systems

Floor Plan (scaled blueprint or sketch) including:

Dimensions of the X-ray room, and location of the control booth if present

Location(s) of the X-ray tube, X-ray table, wall mounted imaging device, CR reader, etc.

Direction(s) of the radiation beam during normal operation

Distance(s) between the areas to be shielded and the operational position of the X-ray tube

Location of the control panel and irradiation switch

Identification of all adjacent rooms, including those rooms located above and below, e.g., offices, storage rooms,
crawl spaces, etc.
The designation of the area to be shielded, controlled area (for radiation workers), or
uncontrolled area (for non-radiation workers and the public)

The Occupancy and Use factors for the areas to be shielded

Medical X-ray Equipment

Manufacturer, brand name and model number of the X-ray system(s)

Maximum selectable tube voltage (kV)

Maximum selectable tube current (mA) or maximum selectable tube current time product (mAs)

Maximum selectable irradiation time (sec)

For film screen system: the manufacturer, type and speed of film screen combination used

For CR system: the manufacturer and brand name of CR reader and storage phosphor system used

Equipment Workload

Number of patients per week

Average tube voltage per procedure (kV)

Average current time product per patient (mAs)

58 Safety Code 35
Table AII.2: Information to calculate shielding requirement for radioscopic X-ray system

Information Required for Radioscopic X-ray Systems

Floor Plan (scaled blueprint or sketch) including:

Dimensions of the X-ray room, and location of the control booth if present

Location(s) of the X-ray tube, X-ray table, image receptor, image display units, etc.

Direction(s) of the radiation beam during normal operation

Distance(s) between the areas to be shielded and the operational position of the X-ray tube

Location of the control panel and irradiation switches

Identification of all adjacent rooms, including those rooms located above and below, e.g., offices, storage rooms,
crawl spaces, etc.
The designation of the area to be shielded, controlled area (for radiation workers), or
uncontrolled area (for non-radiation workers and the public)

The Occupancy factor for the areas to be shielded

Medical X-ray Equipment

Manufacturer, brand name and model number of the X-ray system(s)

Maximum tube voltage (kV)

Maximum tube current time product (mAs)

Number of X-ray tubes on the system

Equipment Workload

Number of patients per week

Average tube voltage per procedure (kV)

Average current time product per patient (mAs)

Safety Code 35 59
Table AII.3: Information to calculate shielding requirement for CT systems

Information Required for CT Systems

Floor Plan (scaled blueprint or sketch) including:

Dimensions of the X-ray room, and location of the control booth

Location(s) of the gantry, patient support, etc.

Distance(s) between the areas to be shielded and the position of the gantry

Location of the control panel and irradiation control

Identification of all adjacent rooms, including those rooms located above and below, e.g., offices, storage rooms,
crawl spaces, etc.
The designation of the area to be shielded, controlled area (for radiation workers), or
uncontrolled area (for non-radiation workers and the public)

The Occupancy factor for the areas to be shielded

Medical X-ray Equipment

Manufacturer, brand name and model number of the CT system

Maximum tube voltage (kV)

Maximum tube current time product (mAs)

Isodose curve for the system (to be provided by the manufacturer)

Equipment Workload

Number of patients per procedure type per week

Average tube voltage per procedure (kV)

CDTI100 and DLP values, if known

60 Safety Code 35
Appendix III:
NCRP #49
Methodology for Calculation of
Shielding Requirements for Diagnostic X-ray Installations

This appendix presents the methodology of NCRP #49 for This method involves computation of an average value for the
determining the shielding necessary in a diagnostic X-ray exposure per unit workload at unit distance, K, (in R/mA-min
installation. The required thickness of shielding can be calcu- at 1 metre) and then using the curves shown in Figures AIII.1
lated using the formulae contained in this Appendix, in and AIII.2 and to determine the thickness of lead or concrete
conjunction with Figures 1 to 3 and the answers to the required to reduce radiation levels to the required value.
following questions:

1. What is the distance between the nearest point of the area 1. Primary Protective Barriers
to be shielding and the mean operational position of the X-ray
For primary protective barriers, the value K can be computed
tube?
from the following equation:
2. Is the area to be designated as a controlled or uncontrolled
area, i.e., will the area be occupied by radiation workers (sub- Pd 2
ject to the limit of 20 mSv per year) or non-radiation workers K= Equation 1
WUT
(subject to the limit of 1 mSv per year)?
where:
3. What will be/is the occupancy factor (T) of the area? The
P = maximum permissible weekly exposure expressed
occupancy factor is defined as the time an area is normally oc-
in R/week. For controlled areas P = 0.04 R/week;
cupied, expressed as a fraction of the working week.
for uncontrolled areas P = 0.002 R/week.
(If not accurately known, use Table 6 in section B1.2.3 of this
Safety Code). d = distance in metres from the target to the primary
area.
4. Will the intervening shield between the X-ray tube
and the occupied area act as a primary or secondary W = workload in mA-min/week
protective barrier, i.e., will the barrier be required to U = use factor
attenuate the direct useful beam or stray (leakage and T = occupancy factor
scattered) radiation only?
K = exposure per unit workload at unit distance, in
5. What will be the use factor (U) of the required protective R/mA-min at 1 metre.
barrier? The use factor is defined as the fraction of the
operational time during which the useful beam will be/is di- Example: Determine the thickness of primary barrier required
rected at the barrier or area under consideration. (If not accu- to protect a controlled area 3 metres from the target of a
rately known, use Table 7 in section B1.2.3 of this Safety 150 kVp diagnostic unit having a weekly workload of
Code). 2000 mA-min. The wall has a use factor of 1 and the occu-
6. What will be/is the workload (W) of the X-ray unit? pancy factor of the area beyond the wall is 1.
The workload indicates the operational time of an X-ray ma-
chine expressed in terms of milliampere-minutes per week. For this case,
7. What will be/is the maximum and average operating tube P = 0.04 R
potential, and output? d = 3m
W = 2000 mA-min
Formulae for U = 1
Calculation of Shielding Requirements T = 1

The thickness of shielding required can be calculated using the

formulae given below. This method requires knowing the
Workload W, in mA-minutes per week, the use factor U, the
occupancy factor T and the distance d, in metres, from the
source to the occupied area.

Safety Code 35 61
Using equation (1), The 150 kVp curves of Figures AIII.1 and AIII.2, respectively
show that the required barrier thickness is 2.65 mm of lead or
0.04 × 32 0.36
K= = 23.5 cm of concrete.
2000 × 1 × 1 2000

K = 0.00018 or 18
. × 10 − 4

Figure AIII.1: Attenuation in lead of X-rays from 50 to 150 kVp

62 Safety Code 35
Figure AIII.2: Attenuation in concrete of X-rays generated at 50 to 150 kVp

2. Secondary Protective Barriers barrier thickness. If the computed leakage and scattering thick-
nesses differ by at least three half-value layers, the larger of
Secondary protective barriers are required to provide shielding the two will be adequate.
against both leakage and scattered radiation. Since these
two types of radiation are of different qualities, it is necessary
to determine the barrier thickness requirements for each sep- 2.1 Barrier Against Leakage Radiation
arately. If the computed barrier thicknesses for leakage and
scatter radiations are about the same, one half-value layer To determine the barrier thickness required to protect against
should be added to the larger one to obtain the total secondary leakage radiation it is necessary to calculate the transmission

Safety Code 35 63
factor, B, required to reduce the weekly exposure to P. For Example: Determine the thickness of barrier required to pro-
a diagnostic-type tube housing, where the maximum allow- tect a controlled area 2 metres from the housing of a 100 kVp
able leakage from the housing is 0.115 roentgen per hour at diagnostic unit having a weekly workload of 2000 mA-min.
1 metre, the transmission factor is given by the following Assume that the tube operates at 5 mA and that the area in
formula: question has an occupancy factor of 1. For this case,
522 IPd 2 P = 0.04 R
B= Equation 2
WT d = 2m

where: W = 2000 mA-min

P = maximum permissible weekly exposure expressed T = 1

in R/week. For controlled areas P = 0.04 R/week; I = 5 mA
for uncontrolled areas P = 0.002 R/week.
d = distance in metres from the tube housing to the Using equation (2),
secondary barrier. 522 × 5 × 0.04 × (2) 2 4176
I = tube current in milliamperes. B= = = 0.209
2000 × 1 2000
W = workload in mA-min/week
T = occupancy factor. From Figure 3, a transmission of 0.209 corresponds to
2.4 HVL’s or 0.7 TVL’s. From Table AIII.1 the HVL for
Having calculated the transmission factor, B, the barrier 100 kVp is 0.27 mm lead or 1.6 cm concrete. Therefore, the
thickness, as a number of half-value layers or tenth-value required barrier thickness for protection against leakage
layers, can be determined from Figure AIII.3. The required radiation is
barrier thickness in millmeters of lead or centimeters of con- (2.4 x 0.27) = 0.65 mm lead
crete can be obtained from Table AIII.1, for the appropriate (2.4 x 1.6) = 3.84 cm concrete
energy.

Figure AIII.3: Relationship between the transmission factor B and the number of half-value layers,
N, or tenth-value layers, n

64 Safety Code 35
Table AIII.1: Half-Value layers and tenth-value layers for heavily filtered X-radiation under broad- beam conditions

Attenuation Material
Tube Potential
Lead (mm) Concrete (cm)
kVp HVL TVL HVL TVL
50 0.06 0.17 0.43 1.5
70 0.17 0.52 0.84 2.8
85 0.22 0.73 1.25 4.5
100 0.27 0.88 1.60 5.3
125 0.28 0.93 2.00 6.6
150 0.30 0.99 2.24 7.4
200 0.52 1.70 2.50 8.4
250 0.88 2.90 2.80 9.4
300 1.47 4.80 3.10 10.4

Table AIII.2: Commercial Lead Sheets

Thickness Weight in Pounds

Thickness
for 1 Square Foot Section
Millimetre Nominal Actual
Inches
Equivalent Weight Weight
1/64 0.40 1 0.92
3/128 0.60 1 1/2 1.38
1/32 0.79 2 1.85
5/128 1.00 2 1/2 2.31
3/64 1.19 3 2.76
7/128 1.39 3 1/2 3.22
- 1.50 - 3.48
1/16 1.58 4 3.69
5/64 1.98 5 4.60
3/32 2.38 6 5.53
- 2.50 - 5.80
- 3.00 - 6.98
1/8 3.17 8 7.38
5/32 3.97 10 9.22
3/16 4.76 12 11.06
7/32 5.55 14 12.90
1/4 6.35 16 14.75
1/3 8.47 20 19.66
2/5 10.76 24 23.60
1/2 12.70 30 29.50
2/3 16.93 40 39.33
1 25.40 60 59.00

Notes:
1. The density of commercially rolled lead is 11.36 g cm-3.
2. The commercial tolerances are ± 0.005 inches for lead up to 7/128 and ± 1/32 for heavier sheets.
3. Lead sheets less than 1/32 inches thick are frequently more expensive than heavier sheets in cost of material and cost of installation.

Safety Code 35 65
2.2 Barrier Against Scatter Radiation Having computed K from equation (3), the curves shown in
Figures AIII.1 and AIII.2 are then used to determine the thick-
Scattered radiation has a much lower exposure rate than that ness of lead or concrete required in the same way as for the
of the incident beam and usually is of lower energy. However, primary barrier.
for X-ray equipment operating below 500 kVp it is usually
assumed that the scattered X-rays have the same barrier If the barrier thickness for leakage and for scattered radiation
penetrating capability as the primary beam. For X-rays gener- differ by at least 1 TVL, the thicker of them will be adequate.
ated at kVp’s of less than 500 kV, the values for K can be If they differ by less than 1 TVL, 1 HVL should be added to
determined from the following formula: the thicker one to obtain the required total secondary barrier
thickness.
400 Pd 2 D 2
K= Equation 3
aWTF

where:
K = exposure per unit workload at 1 metre, expressed in
R per mA-min at 1 m;
P = maximum permissible weekly exposure rate
expressed in R/week. For controlled areas P = 0.04
R/week; for uncontrolled areas P = 0.002 R/week;
d = distance in metres from the target to the scatterer;
D = distance in metres from the scatterer to the sec-
ondary barrier;
a = ratio of scattered to incident exposure (tabulated
in Table AIII.3);
W = workload in mA-min/week;
T = occupancy factor;
F = field are in cm2.

Table AIII.3: Ratio, a, of Scattered to Incident Exposure

Tube Scattering Angle (from Central Axis of Beam)

Potential
kVp 30° 45° 60° 90° 120° 135°
50 0.0005 0.0002 0.00025 0.00035 0.0008 0.0010
70 0.00065 0.00035 0.00035 0.0005 0.0010 0.0013
85 0.0012 0.0007 0.0007 0.0009 0.0015 0.0017
100 0.0015 0.0012 0.0012 0.0013 0.0020 0.0022
125 0.0018 0.0015 0.0015 0.0015 0.0023 0.0025
150 0.0020 0.0016 0.0016 0.0016 0.0024 0.0026
200 0.0024 0.0020 0.0019 0.0019 0.0027 0.0028
250 0.0025 0.0021 0.0019 0.0019 0.0027 0.0028
300 0.0026 0.0022 0.0020 0.0019 0.0026 0.0028

66 Safety Code 35
Appendix IV:
Shielding Guides for Storage of Radiographic Film

To reduce the radiation level to the film to 1.75 µGy (0.2 mR) Table AIV.1 presents the amount of shielding required to
for weekly workloads of: reduce radiation level to 1.75 µGy. In general, for most
500 mA-sec at 100 kV; facilities, the storage time for secondary barriers is adequate.
200 mA-sec at 125 kV;
100 mA-sec at 150 kV.

Table AIV.1: Storage Guide for Radiographic Films

Distance from X-ray tube to stored film

2.0 m 3.0 m 4.0 m 5.0 m
lead concrete lead concrete lead concrete lead concrete
(mm) (cm) (mm) (cm) (mm) (cm) (mm) (cm)
Storage time for primary barriers
1 day 1.6 15.2 1.3 12.6 1.1 10.9 1.0 9.6
1 week 2.3 20.4 1.9 17.9 1.7 15.9 1.5 14.5
1 month 2.8 24.8 2.5 22.3 2.3 20.4 2.1 19.0
1 year 3.9 33.0 3.6 30.5 3.3 28.6 3.1 27.0
Storage time for secondary barriers
1 day 0.2 1.5 0.1 1.0 -- -- -- --
1 week 0.6 5.4 0.3 2.5 0.2 1.5 0.1 1.0
1 month 1.0 9.6 0.7 7.1 0.5 5.4 0.4 3.7
1 year 2.1 17.5 1.7 14.8 1.5 13.0 1.3 11.6

Safety Code 35 67
Appendix V:
Federal/Provincial/Territorial Radiation Safety Agencies

Federal Government Ontario (for issues related to patient and public safety)
Consumer and Clinical Radiation Protection Bureau Ontario Ministry of Health and Long-Term Care
Health Canada X-Ray Inspection Service
P.L. 6301A 5700 Yonge Street, 3rd Floor
775 Brookfield Road North York, Ontario
Ottawa, Ontario M2M 4K5
K1A 1C1

Ontario (for issues related to worker safety)

British Columbia Ministry of Labour
Radiation Protection Service Radiation Protection Service
B.C. Centre for Disease Control 81A Resources Road
Government of British Columbia Weston, Ontario
655, 12th Avenue West M9P 3T1
Vancouver, British Columbia
V5Z 4R4
Quebec
WorkSafe BC Direction de la logistique et des équipements
6951 Westminster Highway Ministère de la Santé et des Services sociaux
Richmond, British Columbia Gouvernement du Québec
V7C 1C6 1005 Chemin Sainte-Foy, 7th Floor
Quebec, Quebec
G1S 4N4
Alberta
Workplace Policy and Standards Development Branch New Brunswick
Alberta Employment, Immigration and Industry Radiation Protection Services
8th floor, 10808-99th Avenue Department of Health and Wellness
Edmonton, Alberta P.O. Box 5100, Carleton Place
T5K 0G5 3rd Floor
Fredericton, New Brunswick
E3B 5G8
Saskatchewan
Radiation Safety Unit
Ministry of Advanced Education, Nova Scotia
Employment and Labour
400-1870 Albert Street Occupational Health and Safety Division
Regina, Saskatchewan Nova Scotia Department of Environment and Labour
S4P 4W1 P.O. Box 697
Halifax, Nova Scotia
B3J 2T8
Manitoba
Radiation Protection Services Prince Edward Island
Department of Medical Physics
CancerCare Manitoba Division of Environmental Health
675 McDermot Avenue Health and Social Services
Winnipeg, Manitoba Government of Prince Edward Island
R3E 0V9 P.O. Box 2000
Charlottetown, Prince Edward Island
C1A 7N8

68 Safety Code 35
Newfoundland and Labrador
Department of Labour
West Block, 4th floor, Confederation Bldg.
P.O. Box 8700
St. John, Newfoundland
A1B 4J6

Northwest Territories
Occupational Health and Safety
Government of the Northwest Territories
Box 1320
Yellowknife, Northwest Territories
X1A 2L9

Yukon Territory
Occupational Health and Safety
Yukon Workers’ Compensation Health and Safety Board
401 Strickland Street
Whitehorse, Yukon Territory
Y1A 5N8

Safety Code 35 69
Appendix VI:
Radiation Emitting Devices Regulations for Diagnostic X-ray Equipment

The Diagnostic X-ray Equipment Regulations, Part XII of the (b) for a field emission device, the X-ray tube voltage and
Radiation Emitting Devices Regulations, in effect at the time the number of pulses; and
of publication of this Safety Code, are shown below. The reg- (c) for any other diagnostic X-ray equipment, the X-ray
ulations have been included here for convenience of reference tube voltage and
only and do not have official sanction. In addition, these reg-
ulations may be amended from time to time. For all purposes (i) the X-ray tube current and irradiation time, or
of interpreting and applying the law, users should consult the (ii) the current time product. (paramètre de charge)
regulations, as registered by the Clerk of the Privy Council and “mammography equipment” means diagnostic X-ray equip-
published in Part II of the Canada Gazette. The Consumer and ment that is used for the examination of breast tissue.
Clinical Radiation Protection Bureau of Health Canada can (appareil à mammographie)
also be contacted for clarification on any of the requirements.
“mobile equipment” means, with respect to diagnostic X-ray
equipment, equipment that is moved between incidents of
use. (appareil mobile)
Schedule I of the Radiation Emitting Devices Regulations
“radiographic equipment” means diagnostic X-ray equipment
that implements a technique in which the information
12. Diagnostic X-ray equipment, being X-ray devices that are
contained in the X-ray pattern is obtained, recorded and
used for the examination of the human body, not including
optionally processed. (appareil de radiographie)
dental X-ray equipment with an extra-oral source that is sub-
ject to Part II of these Regulations, photofluorographic X-ray “radioscopic equipment” means diagnostic X-ray equipment
equipment, radiation therapy simulators and computer-assisted that implements a technique in which continuous or
tomographic equipment. periodic sequences of X-ray patterns are produced and
simultaneously and continuously displayed in the form
PART XII of visible images. (appareil de radioscopie)
DIAGNOSTIC X-RAY EQUIPMENT “radioscopic imaging assembly” means the combination of
Interpretation components in radioscopic equipment that uses X-ray
photons to produce a radioscopic image. These compo-
1.(1) The definitions in this subsection apply in this Part. nents usually consist of the X- ray image receptor, X-ray
image intensifier, equipment housings, interlocks and pro-
“aluminum” means aluminum that has a degree of purity of
tective shielding. (système d’imagerie radioscopique)
99.9% or higher and a density of 2.70 g/cm3. (aluminium)
“rectification type” means, with respect to diagnostic X-ray
“aluminum equivalent” means the attenuation equivalent of an
equipment, the process by which the X-ray generator
object expressed in thickness of aluminum. (équivalent en
converts high voltage to X-ray tube voltage. (type de
aluminium)
redressement)
“field emission device” means a device in which the emission
“stationary equipment” means, with respect to diagnostic
of electrons from the cathode is due solely to the action of
X-ray equipment, equipment that is never moved between
an electric field. (dispositif d’émission par effet de champ)
incidents of use. (appareil fixe)
“general purpose radiographic equipment” means any station-
“X-ray image receptor” means a device that converts incident
ary equipment other than that used solely for the exami-
X-rays into a visible image or into a form that can
nation of specific anatomical regions. (appareil de
be made into a visible image by further transformation.
radiographie pour usage général)
(récepteur d’image radiologique)
“loading factor” means a factor the value of which influences
the X-ray tube load, and includes (2) Unless otherwise defined, words and expressions used
(a) for diagnostic X-ray equipment, if the X-ray beam in this Part have the same meaning as in the International
is produced by the discharge of the capacitor through an Electrotechnical Commission Standard entitled Medical radi-
X-ray tube, the X-ray tube voltage and the amount of ology —Terminology, Publication 788, First edition, 1984.
capacitor charge;

70 Safety Code 35
 Information and Labelling (a) on the external surface of the main control panel
Information (i) a statement prohibiting unauthorized use and
2. The manufacturer must ensure that the following warning that hazardous X-rays are emitted when
information accompanies each piece of diagnostic X-ray the equipment is in operation,
equipment: (ii) the X-ray warning symbol described in section
(a) the installation instructions; 4, and
(b) the address of the manufacturer; (iii) with respect to the X-ray generator,
(c) any radiological safety procedures and additional pre- (A) the name of the manufacturer,
cautions that are necessary because of any unique features (B) the model designation,
of the equipment;
(C) the serial number,
(d) the maintenance instructions necessary to keep the
equipment in compliance with the requirements of this (D) the date of manufacture, and
Part; (E) the country of manufacture;
(e) the rated line voltage, the maximum line current and (b) on the external surface of the X-ray tube housing, with
the line voltage regulation for the operation of the equip- respect to the X-ray tube assembly,
ment at the maximum line current; (i) the name of the manufacturer,
(f) the loading factors that constitute the maximum line (ii) the model designation,
current condition for the X-ray generator;
(iii) the serial number,
(g) for each X-ray tube assembly,
(iv) the date of installation of the X-ray tube in the
(i) the nominal focal spot sizes and the method of X-ray tube housing,
their determination,
(v) the country of manufacture, and
(ii) the cooling curves for the anode and for the
(vi) the minimum permanent inherent filtration
X-ray tube housing,
of the X-ray beam emitted from the X-ray tube
(iii) the X-ray tube rating charts, and assembly, expressed in millimetres of aluminum
(iv) the method by which the focal spot to image equivalent at a specified X-ray tube voltage;
receptor distance can be determined using the (c) on the external surface of the X-ray tube housing
indicator specified in subparagraph 3(c)(i); or another suitable structure permanently attached to the
(h) its duty cycles, rectification type and generator rating; X-ray tube housing
(i) if the equipment is battery powered, the minimum state (i) an indicator that enables the focal spot to image
of charge necessary for it to operate; receptor distance to be determined to within 2% of
(j) the operating range of X-ray tube voltages and the that distance, and
maximum deviation for any selected X-ray tube voltage (ii) if the X-ray tube and the X-ray generator are
within that range of values; not located within a common enclosure, marks that
(k) if the equipment is not operated exclusively in auto- clearly indicate the anode and cathode terminals on
matic exposure control mode, the accuracy limits of the X-ray tube housing and on the high-voltage
generator; and
(i) the controlling timer,
(d) on the external surface of any beam limiting device
(ii) the X-ray tube current, and that adds filtration to the X-ray beam, the total permanent
(iii) the current time product; filtration deliverable by the beam limiting device,
(l) where the equipment operates under automatic expo- expressed in millimetres of aluminum equivalent at a
sure control, the accuracy limits of that control; and specified X-ray tube voltage.
(m) the conditions under which the information provided
under paragraphs (j) to (l) is valid. 4. The X-ray warning symbol shall
(a) be displayed in two contrasting colours;
Labelling (b) be visible and identifiable from a distance of 1 m;
3. Diagnostic X-ray equipment must display the following (c) be at least 2 cm high and at least 2 cm wide;
information in a manner that is legible, permanent and visible
on the specified surfaces:

Safety Code 35 71
 (d) bear the words (d) on the control panel
“CAUTION: X-RAYS—ATTENTION : RAYONS X”; (i) a warning light that indicates when the equip-
and ment is ready to be energized,
(e) conform to (ii) a second warning light that indicates when
(i) the following diagram: X-rays are being emitted,
(iii) if an automatic exposure control is provided, a
visual indicator showing when that mode of oper-
ation is selected, and
(iv) if the automatic exposure control mode is not
selected or does not exist, controls and visual indi-
or cators that enable the operator to select the loading
(ii) symbol 03-03 in the report of the International factors before an irradiation;
Electrotechnical Commission entitled Graphical (e) if the equipment is battery powered, a visual indicator
symbols for electrical equipment in medical prac- on the control panel showing whether the battery is ade-
tice, Publication 878, 1988, illustrated as follows: quately charged for the proper operation of the equipment;
(f) a mechanism to initiate and terminate an irradiation;
(g) an audible signal to indicate the termination of an
irradiation;
(h) in the case of equipment other than mammography
equipment, if an X-ray source assembly has a permanent
5. All controls, meters, warning lights and other indica- inherent filtration of 0.5 mm aluminum equivalent or less,
tors required by this Part must be clearly labelled as to their a means to add additional filtration;
function. (i) if the equipment moves around a patient by remote
control, an emergency stop switch that immediately
terminates both the motion of the equipment and the
Construction Standards emission of X-rays;
General Requirements (j) a beam limiting device; and
(k) for equipment that operates within a range set out in
6. Diagnostic X-ray equipment must have column 1 of an item of the table to this paragraph, radia-
(a) if more than one X-ray tube is controlled by one con- tion filters that result in a measured half-value layer of
trol panel, aluminum of not less than
(i) a visual indicator on or near each X-ray tube (i) for each X-ray tube voltage set out in column 2
housing that shows that the X-ray tube to which of that item, the half-value layer set out in
the indicator applies is connected and ready to be column 3 of that item, or
energized, and (ii) in any other case, the half-value layer obtained
(ii) a visual indicator on the control panel that by linear interpolation or extrapolation from that
shows which of the X-ray tubes are connected and table.
ready to be energized;
(b) a means, appropriate to the rectification type of the
equipment, to compensate for variations in X-ray tube
voltage caused by line voltage fluctuations;
(c) a visual or audible indicator that warns the operator
when the variation in line voltage exceeds the rate set
out in subsection 23(2) or a mechanism that, in that event,
prevents X-rays from being emitted;

72 Safety Code 35
 Table to paragraph 6 (k) the aluminum equivalent of the object shall not
Minimum Half-value Layer of Aluminum exceed the amount set out in column 2 of that item, as
Column 1 Column 2 Column 3 determined using an X-ray beam that
Operating Range X-ray Tube Half-value Layer (a) is generated at an X-ray tube voltage of 100 kV;
for Normal Use Voltage of Aluminum
Item (kV) (kV) (mm) (b) has a maximum X-ray tube voltage ripple of 10%; and
1. 50 or less (a) 30 0.3 (c) has a half-value layer of aluminum of 3.7 mm.
(b) 40 0.4
(c) 50 0.5

2. 50 or more (a) 50 1.2 Table to subsection 8(1)

but not (b) 60 1.3 Non-mammography Equipment—
more than 70 (c) 70 1.5 Maximum Aluminum Equivalent of Interpositioned Objects

3. 70 or more (a) 70 2.1

Column 2
(b) 80 2.3
Maximum
(c) 90 2.5
Aluminum
(d) 100 2.7
Column 1 Equivalent
(e) 110 3.0 Item Object (mm)
(f) 120 3.2
(g) 130 3.5 1. Front panel of cassette holder 1.2
(h) 140 3.8 (total of all layers)
(i) 150 4.1
2. Front panel of film changer 1.2
(total of all layers)

7.(1) An irradiation switch for diagnostic X-ray equip- 3. Cradle 2.3

ment must
4. Fixed patient support without an 1.2
(a) permit the emission of X-rays only when the operator articulated joint
exerts continuous pressure on the switch;
5. Movable patient support without 1.7
(b) in the case of a foot switch, prevent the emission of an articulated joint, including any
any unintended X-rays when it is overturned; and fixed layers
(c) in the case of mobile equipment, permit the operator to 6. Patient support with one articulated 1.7
stand at least 3 m from the X-ray source when the X-ray joint and a radiolucent panel
tube is energized.
7. Patient support with two or more 2.3
articulated joints and a radiolucent
(2) The controlling timer for diagnostic X-ray equipment must panel
(a) automatically terminate an irradiation
8. Cantilevered patient support 2.3
(i) on completion of a preset irradiation time,
(ii) on attainment of a preset current time product
value, or (2) In the case of mammography equipment, when an object
set out in column 1 of an item of the table to this subsection is
(iii) on completion of a preset number of X-ray
positioned between the patient and the X-ray image receptor,
pulses;
the aluminum equivalent of the object shall not exceed the
(b) permit the operator to terminate an irradiation at any amount set out in column 2 of that item, as determined using
time; an X-ray beam that
(c) automatically reset itself to its original setting or to (a) is generated at an X-ray tube voltage of 30 kV;
zero on termination of an irradiation; and
(b) has a maximum X-ray tube voltage ripple of 10%;
(d) prevent the initiation of irradiation when the timer is and
set at zero, at the “off” position or at an unmarked setting.
(c) has a half-value layer of aluminum of 0.3 mm.

8.(1) In the case of diagnostic X-ray equipment, other than

mammography equipment, when an object set out in
column 1 of an item of the table to this subsection is
positioned between the patient and the X-ray image receptor,

Safety Code 35 73
 Table to subsection 8(2) (c) when an irradiation under automatic exposure control
Mammography Equipment— terminates because the limits specified in paragraph (b)
Maximum Aluminum Equivalent of Interpositioned Objects have been reached,
Column 2 (i) a visual indicator or audible signal that warns
Maximum the operator of the termination, and
Aluminum
Column 1 Equivalent (ii) a reset control that must be activated manually
Item Object (mm) before another irradiation under automatic expo-
sure control can be made.
1. Support table, including all layers 0.3

11.(1) General purpose radiographic equipment must have

(3) For the purposes of subsections (1) and (2), any sensor (a) a beam limiting device that
used in automatic exposure control is a part of the X-ray image (i) permits stepless adjustment of the size of the
receptor. X-ray field, and
(ii) when it is set at the smallest aperture and at a
9. For diagnostic X-ray equipment, focal spot to image receptor distance of 1 m, has
(a) the X-ray tube must be securely affixed to and aligned an X-ray field of 5 cm by 5 cm, or less;
within the X-ray tube housing; (b) an X-ray field indicator that uses light to visually de-
(b) the radiation filters must be securely affixed to the exit fine the X-ray field so that the limits of the X-ray field are
port of the X-ray tube housing or beam limiting device, or visible under the ambient lighting conditions in an X-ray
both; and room; and

(c) the X-ray source assembly must maintain its required (c) a means by which the operator may
position or movement without drift or vibration during (i) determine when the X-ray beam axis is perpen-
operation. dicular to the image receptor plane,
(ii) determine the focal spot to image receptor
Radiographic Equipment distance to within 2% of that distance, and
10. Radiographic equipment that is equipped with an (iii) align the centre of the X-ray field with the
automatic exposure control must have centre of the image reception area to within 2% of
(a) if the operating X-ray tube voltage is 50 kV or more, the focal spot to image receptor distance.
a minimum irradiation time capability that does not
exceed (2) The X-ray field indicator referred to in paragraph (1)(b)
(i) in the case of a field emission device that oper- must
ates in pulse mode, the time equivalent to two (a) illuminate on average at a minimum of 100 lx when
pulses, or measured from the lesser of
(ii) in the case of any other radiographic equip- (i) the distance of 1 m from the X-ray source, or
ment, the greater of 1/60 s or the time required to (ii) the maximum focal spot to image receptor
deliver a current time product of 5 mAs; distance;
(b) a means to automatically terminate the irradiation (b) be circumscribed by the beam limiting device;
when
(c) have as its perimeter the locus of points at which the
(i) if the operating X-ray tube voltage is less than illumination is one fourth of the maximum illumination
50 kV, the current time product exceeds 1,200 mAs in the area; and
per irradiation, or
(d) when the X-ray beam axis is perpendicular to the
(ii) if the operating X-ray tube voltage is 50 kV or image receptor plane, visually define the X-ray field
more, within the following specifications, namely,
(A) the current time product exceeds (i) the separation between the perimeter of the
600 mAs per irradiation, or visually defined field and that of the X-ray field
(B) the product of the X-ray tube voltage, does not exceed 2% of the focal spot to image
X-ray tube current and irradiation time receptor distance, and
exceeds 60 kVAs per irradiation; and

74 Safety Code 35
 (ii) the dimensions of the X-ray field are indicated (i) the horizontal plane, when the focal spot to
and are accurate to within 2% of the focal spot to image receptor distance is 90 cm or more but not
image receptor distance. more than 205 cm, or
(ii) the vertical plane, when the focal spot to image
12.(1) General purpose radiographic equipment that has a receptor distance is 90 cm or more but not more
positive beam limiting system must than 130 cm; and
(a) permit stepless adjustment of the size of the X-ray (e) neither tomography nor stereoscopic radiography is
field; being performed.
(b) when it is set at the smallest aperture and at a focal
spot to image receptor distance of 1 m, have an X-ray field 13.(1) Subject to section 14, radiographic equipment,
of 5 cm by 5 cm, or less; other than general purpose radiographic or mammography
(c) permit adjustment of the size of the X-ray field to equipment, must have a fixed-aperture beam limiting device
dimensions that are smaller than those of the image that, for the combination of image reception area and focal
reception area; spot to image receptor distance described in subsection (2),
(d) under the conditions of operation specified in subsec- (a) permits the centre of the X-ray field to be aligned with
tion (2), the centre of the image reception area to within 2% of the
focal spot to image receptor distance; and
(i) automatically adjust the dimensions of the X-
ray field to the dimensions of the image reception (b) prevents the X-ray field from extending beyond any
area, or to a selected portion of that area, within edge of the image reception area.
5 s after insertion of the image receptor, or
(2) The fixed-aperture beam limiting device referred to in sub-
(ii) prevent the emission of X-rays until the beam section (1) must display on its exterior surface a specified focal
limiting device is manually adjusted so that spot to image receptor distance and the dimensions of its
(A) the dimensions of the X-ray field do not image reception area at that distance.
exceed those of the image reception area, or
the selected portion of that area, by more 14. Mobile radiographic equipment that does not meet the
than 3% of the focal spot to image receptor requirements of section 13 must have
distance, and
(a) a beam limiting device that
(B) the sum of the absolute values of the
differences in the dimensions of the X-ray (i) permits stepless adjustment of the size of the
field and the image reception area, or the X-ray field, and
selected portion of that area, does not (ii) when it is set at the smallest aperture and at a
exceed 4% of the focal spot to image focal spot to image receptor distance of 1 m, has
receptor distance; and an X-ray field of 5 cm by 5 cm, or less;
(e) automatically revert to one of the requirements set out (b) an X-ray field indicator referred to in paragraph
in paragraph (d) on any change to 11(1)(b) that, when the X-ray beam axis is perpendicular
(i) the dimensions of the image reception area, or to the image receptor plane, permits the alignment of the
edges of the illuminated field with the edges of the X-ray
(ii) the focal spot to image receptor distance, if the field so that the difference between their edges does not
change would result in failure to meet the require- exceed 2% of the focal spot to image receptor distance;
ments of paragraph (d). and
(2) For the purposes of paragraph (1)(d), the conditions of (c) a means to determine the focal spot to image receptor
operation are as follows: distance to an accuracy of 2% or less of that distance.
(a) the image receptor is inserted into a permanently
mounted cassette holder; 15.(1) Mammography equipment must have
(b) neither the length nor the width of the image recep- (a) a beam limiting device that limits the size of the
tion area exceeds 50 cm; X-ray beam to prevent the X-ray field, at any focal spot to
image receptor distance at which the equipment operates,
(c) the X-ray beam axis is within 3° of the perpendicular from extending
to the image receptor plane;
(i) more than 5 mm beyond the edge of the patient
(d) the X-ray beam axis is within 3° of support next to the chest wall of the patient, and

Safety Code 35 75
 (ii) more than a distance equivalent to 2% of the image reception area by a distance that does
focal spot to image receptor distance beyond any not exceed 3% of the focal spot to image
other edge of the image reception area; receptor distance, and
(b) an image receptor supporting device that (B) the sum of the absolute values of the
(i) has protective shielding that limits the residual differences in the dimensions between the
radiation in accordance with section 26, X-ray field size and the image reception
area does not exceed 4% of the focal spot to
(ii) extends to the patient’s chest wall, and image receptor distance, and
(iii) at every other edge, extends beyond the X-ray (iv) permits the centre of the X-ray field to be
field by at least 1% of the focal spot to image re- aligned with the centre of the selected portion of
ceptor distance; and the image reception area to within 2% of the focal
(c) a breast compression device that spot to image receptor distance;
(i) is foot-actuated to start the compression, (c) a mechanism for adjusting the X-ray field to dimen-
(ii) permits fine adjustment of motion during the sions that are smaller than those of the selected portion of
compression, the image reception area so that
(iii) permits rapid decompression, (i) when the mechanism is set at the smallest aper-
ture and at the longest focal spot to image receptor
(iv) has motion adjustment controls on both sides
distance, the X-ray field is 5 cm by 5 cm, or less,
of the position for the patient, and
and
(v) allows the portion of the compression plate
(ii) the requirement set out in subparagraph (b)(iv)
in contact with the breast to be brought to within
is met when the X-ray beam axis is perpendicular
10 mm of the surface of the patient support.
to the image receptor plane; and
(d) if a means is provided for the operator to override a
(2) Mammography equipment that has a removable, fixed-
failure of the automatic X-ray field size adjustment, a
aperture beam limiting device must display the following
visual indicator at the operator’s position that shows when
information on its external surface:
the override is activated.
(a) the dimensions of the image reception area; and
(b) the focal spot to image receptor distance at which the 17. Radiographic equipment, other than equipment de-
beam limiting device must be used. scribed in sections 11 to 16, must have a beam limiting device
that, when the axis of the X-ray beam is perpendicular to the
16. Diagnostic X-ray equipment that has a spotfilm de- image receptor plane, permits
vice must have (a) the alignment of the centre of the X-ray field with the
(a) if the angle of the image receptor plane or of the X-ray centre of the image reception area to within 2% of the
source assembly is adjustable by the operator, a means to focal spot to image receptor distance; and
indicate when the X-ray beam axis is perpendicular to the (b) the adjustment of the perimeter of the X-ray field so
image receptor plane; that the perimeter does not extend beyond that of the
(b) when the X-ray beam axis is perpendicular to the image reception area by more than 2% of the focal spot to
image receptor plane, a mechanism that image receptor distance.
(i) when the X-ray field is larger than the selected
portion of the image reception area, adjusts the di- Radioscopic Equipment
mensions of the field automatically to those of the 18. Radioscopic equipment must
selected portion of that area, (a) have an X-ray image intensifier that includes protec-
(ii) when the X-ray field is smaller than the se- tive shielding that
lected portion of the image reception area, permits (i) for any focal spot to image receptor distance,
the adjustment of the dimensions of the X-ray field, intercepts the entire cross section of the X-ray
(iii) permits the perimeter of the X-ray field to be beam,
aligned with that of the selected portion of the (ii) intercepts the X-ray beam and scattered radia-
image reception area so that tion from the image intensifier that would other-
(A) the dimensions of the X-ray field differ wise reach the operator,
from the corresponding dimensions of the

76 Safety Code 35
 (iii) prevents the radioscopic X-ray tube from (iii) for radioscopic equipment fitted with an X-ray
emitting X-rays unless the protective shielding is image intensifier and used for special applications
in place to intercept the X-ray beam, and that require shorter focal spot to skin distances than
(iv) sufficiently attenuates the X-rays transmitted the focal spot to skin distances specified in sub-
through or scattered from the entrance window of paragraphs (i) and (ii), to 20 cm, or
the radioscopic imaging assembly to meet the (iv) for small-format, low-intensity radioscopic
requirements of section 32; equipment, to the distance at which the equipment
(b) for mobile radioscopic equipment, have an X-ray delivers an air kerma rate of 50 mGy/min or an
image intensifier that is an integral part of the equipment exposure rate of 5.75 R/min.
or is interlocked in such a manner that its removal pre-
vents X-rays from being produced; 19. Radioscopic equipment that is used for cineradiogra-
(c) for stationary radioscopic equipment, prevent the phy must have visual indicators that continuously display the
X-ray tube from producing X-rays when there is no image X-ray tube voltage and the X-ray tube current.
receptor in place to intercept the X-ray beam;
(d) for stationary radioscopic equipment that is not 20. A high-level irradiation control for radioscopic equip-
equipped with remote control, ment must
(i) have protective shielding of at least 0.25 mm (a) be activated by a separate means that requires contin-
lead equivalent at 100 kV, such as overlapping uous pressure by the operator for it to emit X-rays; and
hinged or sliding panels or protective drapes, to in- (b) when it is in use, emit a continuous audible signal or
tercept the scattered radiation that would otherwise an intermittent signal with silent periods of no longer than
reach the operator, and one second.
(ii) the capability to remove the protective shield-
ing referred to in subparagraph (i) when it inter- Functioning Standards
feres with the performance of diagnostic 21. Diagnostic X-ray equipment must function in
procedures; accordance with the requirements set out in sections 22 to 32
(e) have an irradiation switch that during its operation under normal conditions of use.
(i) requires continuous pressure by the operator for
the entire period of an irradiation, and 22.(1) The definitions in this subsection apply in this
(ii) enables the operator to terminate the recording section.
of serial radioscopic images at any time; “coefficient of variation” means the ratio of the estimated stan-
(f) have a chronometer that dard deviation to the mean value of a series of measure-
ments calculated using the equation:
(i) indicates the amount of time that the equipment
has been emitting X-rays, and 1/ 2
⎡ n ( X − X )2 ⎤
(ii) can be reset to zero or any other selected value; S 1 ⎢∑ i ⎥
C= = ⎢ i=1 ⎥
(g) have a positive beam limiting system that, when the X X⎢ n−1 ⎥
X-ray beam axis is perpendicular to the image receptor ⎣ ⎦
plane, permits the alignment of the perimeter of the illu- where
minated field with that of the X-ray field so that C is the coefficient of variation;
(i) the difference between the perimeters does not S is the estimated standard deviation;
exceed a distance equivalent to 3% of the focal spot
to image receptor distance, and Xi is the value of the ith measurement;
(ii) the sum of the excess length and excess width X is the mean value of the measurements; and
does not exceed 4% of the focal spot to image re- n is the number of measurements. (coefficient de
ceptor distance; variation)
(h) have visual indicators that continuously display the “exposure to the X-ray image receptor” means the amount of
X-ray tube voltage and the X-ray tube current; and X-rays, registered by one or more detectors located in a
(i) have a device that limits the minimum focal spot to fixed position in proximity to the X-ray image receptor,
skin distance that is necessary to produce a radiogram of the overall
density sought by the operator. (dose d’irradiation au
(i) for mobile radioscopic equipment, to 30 cm, récepteur d’image radiologique)
(ii) for stationary radioscopic equipment, to 38 cm,

Safety Code 35 77
(2) For any combination of X-ray tube voltage, X-ray tube Table to Subsection 23(2)
current and irradiation time, or for any selected exposure to Maximum Deviation of Loading Factors
the X-ray image receptor, when the line voltage for each meas- Column 2
urement is accurate to within 1% of the mean line voltage Maximum
value of all the measurements, and when all variable controls Deviation
for the loading factors are adjusted to alternate settings and from the
Column 1 Seletected Value
reset to the test setting before each measurement, Item Loading Factor (mm)
(a) the coefficient of variation of any 10 consecutive air
kerma or exposure measurements, taken at the same point 1. X-ray tube voltage of mammography 5%
equipment
along the X-ray beam axis within a period of one hour,
must be no greater than 0.05; and 2. X-ray tube voltage of non- mammog- 10%
raphy equipment
(b) each of the 10 air kerma or exposure measurements
taken under paragraph (a) must be within 15% of the 3. Irradiation time 10% plus 1 ms
mean value of those measurements.
4. X-ray tube current 20%
(3) For the purposes of subsection (2), diagnostic X-ray equip- 5. Current time product 10% plus 0.2 mAs
ment with an automatic exposure control must have attenuat-
ing material in the X-ray beam that is thick enough that the
loading factors can be adjusted to provide single irradiations of
at least 24.(1) The controlling timer or automatic exposure
(a) 12 pulses, in the case of a field emission device that control device of diagnostic X-ray equipment must have a
operates in pulse mode; or minimum irradiation time capability that does not exceed the
greater of:
(b) 0.1 s, in the case of any other diagnostic X-ray equip-
ment. (a) 1/60 s, or
(b) the time required to deliver a current time product of
23.(1) This section applies in respect of diagnostic X-ray 5 mAs.
equipment that has
(2) If the automatic exposure control of diagnostic X-ray
(a) a high-voltage generator that is not a stored energy
equipment is selected, the variation in optical density set out in
high-voltage generator;
subsection (3) or (4) must be determined using objects that are
(b) loading factors that do not change automatically to made of human-tissue equivalent material and have thick-
compensate for unintentional variations in X-ray tube nesses that are representative of the actual range of the body
voltage; and thicknesses of the patients.
(c) an irradiation time of at least 0.1 s and a current time
product of at least 5 mAs. (3) The automatic exposure control device of diagnostic
X-ray equipment, other than mammography equipment, when
(2) In the case of a line voltage regulation of 6% or less, the the X-ray tube voltage and the thickness of the objects
loading factor set out in column 1 of an item of the table to described in subsection (2) are held constant or varied as
this subsection must not deviate from the selected value, for specified in columns 1 and 2 of an item of the table to this
any combination of loading factors, by more than the quantity subsection, must limit the variation in optical density of the
set out in column 2 of that item. resulting radiograms to the quantity set out in column 3 of that
item.

Table to Subsection 24(3)

Maximum Variation in Optical Density

Column 3
Column 1 Column 2 Maximum
X-ray Tube Thickness Variation in
Item Voltage of the Object Optical Density
1. Variable Constant 0.15
2. Constant Variable 0.20
3. Variable Variable 0.20
4. Constant Constant 0.10

78 Safety Code 35
(4) The automatic exposure control device of mammography 26.(1) For mammography equipment, the residual radia-
equipment, when both the X-ray tube voltage and the thick- tion behind the image receptor supporting device must not
ness of the objects described in subsection (2) are varied, must exceed an air kerma measurement of 1.0 µGy or an exposure
limit the variation in optical density of the resulting radiograms measurement of 0.115 mR per irradiation when the equipment
to 0.15. is operated at
(a) its maximum X-ray field and minimum focal spot
25.(1) For any selected value of X-ray tube voltage within to image receptor distance; and
a range determined in accordance with subsection (2), the (b) its maximum X-ray tube voltage and maximum
quotients of the average air kerma or exposure measurement current time product.
divided by the indicated current time product, obtained at the
applicable settings specified in subsection (3), must not differ (2) For the purposes of subsection (1), the air kerma or expo-
by more than 0.10 times their sum as determined by the sure measurement must be averaged over a detection area that
formula is 100 cm2, of which no linear dimension is greater than
20 cm, centred at 5 cm from any accessible surface beyond the
X 1 − X 2 ≤ 01
. ( X1 + X 2 ) image receptor supporting device.

where 27.(1) Mammography equipment must have a minimum

X1 is the quotient of the average air kerma or exposure rate of radiation output of 7.0 mGy/s or 802 mR/s when the
measurement divided by the current time product equipment is operated
determined at the first of the two applicable set- (a) with a molybdenum anode and molybdenum filter;
tings specified in subsection (3); and
(b) with the breast compression device in place between
X2 is the quotient of the average air kerma or exposure the X-ray source and the detector; and
measurement divided by the current time product
determined at the second of the two applicable (c) at an X-ray tube voltage of 28 kV in standard mam-
settings specified in subsection (3). mography mode at any focal spot to image receptor
distance.
(2) The range referred to in subsection (1) is the smaller of
(2) For the purposes of subsection (1), the minimum rate of
(a) 40% to 90% of the maximum available X-ray tube radiation output must be
voltage, or
(a) measured at a position that is 4.5 cm above the patient
(b) the range of X-ray tube voltages specified for the support; and
diagnostic X-ray equipment by the manufacturer.
(b) averaged over a period of irradiation of 3.0 s.

(3) The quotients referred to in subsection (1) must be deter-

mined at 28.(1) Radioscopic equipment that has a feature described
in column 1 of an item of the table to this subsection, other
(a) if the X-ray tube current is selected in discrete steps, than when radioscopic images are being recorded, must not
any two consecutive X-ray tube current settings; operate at any combination of X-ray tube voltage and X-ray
(b) if the X-ray tube current selection is continuous, any tube current that results in an air kerma rate that exceeds that
two X-ray tube current settings that differ by a factor of set out in column 2 of that item or an exposure rate that
2 or less; exceeds that set out in column 3 of that item:
(c) if the current time product is selected in discrete steps,
any two consecutive current time product settings; or
(d) if the current time product selection is continuous, any
two current time product settings that differ by a factor of
2 or less.

(4) If diagnostic X-ray equipment has more than one focal

spot, the quotients referred to in subsection (1) must be deter-
mined for all combinations of two focal spots that have a nom-
inal focal spot size greater than 0.45 mm, and all combinations
of two focal spots that have a nominal focal spot size equal to
or less than 0.45 mm at the applicable settings set out in sub-
section (3).

Safety Code 35 79
 Table to Subsection 28(1)
Maximum Air Kerma or Exposure Rate of Radioscopic
Equipment, Other Than When It Is Recording Images

Column 2 Column 3
Column 1 Maximum Air Maximum
Item Feature Kerma Rate Exposure Rate

1. Not equipped with an automatic intensity control 50 mGy/min 5.75 R/min

2. Equipped with an automatic intensity control 100 mGy/min 11.5 R/min

3. Equipped with both an automatic intensity control and a high-level irradiation control 150 mGy/min 17.25 R/min
when the latter is activated

(2) For the purposes of subsection (1), the air kerma or expo- (2) For the purposes of subsection (1), the rate must be aver-
sure rate must be determined at a location along the X-ray aged over a detection area of 10 cm2, of which no linear
beam axis that is dimension is greater than 5 cm, that is centred at 5 cm from
(a) if the X-ray source is below the table, 1 cm above the any accessible surface of the X-ray source assembly.
table;
(b) if the X-ray source is above the table, 30 cm above the 31.(1) Under any operating condition, the radiation from
table and with the X-ray source assembly positioned as any component of diagnostic X-ray equipment, other than the
closely as possible to the location of the measurement; X-ray source assembly, must not exceed an air kerma rate of
20.0 µGy/h or an exposure rate of 2.3 mR/h.
(c) if the equipment is a C-arm radioscope, 30 cm from the
input surface of the radioscopic imaging assembly; or
(2) For the purposes of subsection 1, the rate must be averaged
(d) if the equipment is a lateral type radioscope, 15 cm over a detection area of 10 cm2, of which no linear dimension
from the centre line of the table in the direction of the X- is greater than 5 cm, that is centred at 5 cm from any accessi-
ray source and with the X-ray source assembly positioned ble surface of the component.
as closely as possible to the location of the measurement
for all positions of the table.
32.(1) In the case of radioscopic equipment, the radiation
resulting from the transmission of the X-ray beam through, or
29.(1) The leakage radiation from the X-ray source as- scattered from, the entrance window of the radioscopic imag-
sembly of diagnostic X-ray equipment must not exceed an air ing assembly must not exceed an air kerma rate of 2 mGy/h for
kerma rate of 1.0 mGy/h or an exposure rate of 115 mR/h an entrance air kerma rate of 1 Gy/min or an exposure rate of
when the equipment is operated at the nominal X-ray tube con- 2 mR/h for an entrance exposure rate of 1 R/min.
ditions of loading that correspond to the maximum specified
energy input in one hour. (2) For the purposes of subsection (1), the rate must be
(2) For the purposes of subsection (1), the rate must be (a) taken at the applicable location specified in subsection
averaged over a detection area of 100 cm2, of which no linear 28(2) for the type or configuration of the equipment;
dimension is greater than 20 cm, that is centred at 1 m from the (b) taken with an attenuation block made of aluminum and
focal point. having the dimensions 20 cm by 20 cm by 3.8 cm that is
positioned between the point of entrance of the radiation
30.(1) If high voltage can appear across the X-ray tube of and the image reception area of the radioscopic imaging
the diagnostic X-ray equipment, then the radiation emitting assembly; and
from the X-ray source assembly of the equipment must not (c) averaged over a detection area of 100 cm2 that is
exceed an air kerma rate of 20.0 µGy/h or an exposure rate of centred 10 cm from any accessible surface of the radio-
2.3 mR/h when scopic imaging assembly and in a plane beyond the image
(a) the equipment is operated with its beam limiting receptor.
device fully open; and
(b) the automatic exposure control or the irradiation
switch has not been activated.

80 Safety Code 35
Appendix VII:
Facility Radiation Protection Checklist

Table VII.1: Facility Radiation Protection Checklist

Reference
Description Yes / No
Subsection
Personnel Qualifications and Responsibilities
Do all personnel possess the required qualifications to carry out all of their responsibilities? A1.0
Owner: A1.1
Responsible User: A1.2
X-ray Equipment Operator: A1.3
Medical Physicist/Radiation Safety Officer: A1.4
Referring Physician/Practioner: A1.5
Information Systems Specialist: A1.6
Repair and Maintenance Personnel: A1.7
Procedures for Minimizing Radiation Exposure to Personnel
In general, are all required and recommended procedures for minimizing exposures to A2.0
personnel in place and being followed?

Are all personnel who are likely to receive more than 1/20th of the dose to a radiation worker A2.1
declared radiation workers and monitored with a personal dosimeter? If yes, are the dosimeters:

worn properly?
read at an appropriate frequency?
Are personnel exposures within regulatory limits? A2.1
Are personal protective equipment available to all staff? A2.1
Does the facility use mobile equipment? A2.2
If yes, are the requirements and recommendations of section A2.2 being followed?

In general, are all required and recommended procedures for operation of radiographic A2.3
equipment in place and being followed?

When operating radioscopic equipment, are measures taken to protect personnel? A2.4

Protective clothing worn by staff

Minimizing duration of exposures
Minimizing dose-rate and X-ray field size
Assessment of positioning of personnel during examinations

Procedures for Minimizing Radiation Exposure to Patients

In general, are the guidelines for the prescription of X-ray examinations being followed? A3.1
Are medical exposures justified by taking into account the benefits and risks of alternate A3.1
procedures that do not use ionizing radiation but offer comparable information?

Are previous radiographs or reports consulted prior to prescribing additional radiological A3.1
examinations?
In general, are the guidelines for radiological examinations of pregnant women being followed? A3.2
Are radiological procedures causing exposure of the abdomen or pelvis of women who are A3.2
pregnant avoided unless there are strong clinical reasons for such examinations?

Are radiological procedures causing exposure of the abdomen or pelvis of women of A3.2
reproductive capacity planned to deliver the minimum dose to any embryo or foetus?

In general, are all required and recommended procedures for carrying out X-ray examinations in A3.3
place and being followed?

Safety Code 35 81
 Reference
Description Yes / No
Subsection
Are patients treated only when the appropriate prescription is provided by a medical practitioner? A3.3.1
Do equipment operators select techniques and loading factors such that their combination A3.3.1
produces the minimum patient exposure consistent with acceptable image quality and the
clinical purpose of the examination?
Is adequate patient shielding available and used where appropriate and practicable? A3.3.1
In general, are all required and recommended procedures for carrying out radiograhic A3.3.2
examinations in place and being followed?
For each type of interventional procedure, is there documented information available outlining A3.3.3
the radiographic films (projections, number and loading factors), radioscopy time, air kerma
rates and resulting cumulative skin doses and skin sites associated with the various part of the
interventional procedure?
In general, are practices and procedures in place for carrying out CT procedures? A3.3.5
Are efforts made to reduce the dose to sensitive tissues? A3.4

Correct collimation of X-ray beam?

Attention to X-ray examinations of children and adolescents?
Gonad shielding?
Appropriate selection of loading factors and technique?
Attention to sensitivity of imaging system?
Have Diagnostic Reference Levels been established and documented? If yes, A3.5
are the DRLs established using

phantoms? or
patients?
Facility Requirements
Is shielding adequate such that the dose rates outside the controlled areas meet the regulatory B1.1
dose limits for the public?

Are routine measurements of exposure rates in areas adjacent to the radiology rooms made B1.1
by the staff or qualified experts?

Is there an up-to-date floor plan available containing the information required in B1.2
subsection B1.2.1?
Are controlled areas identified by appropriate warning signs? B1.2.2
Are warning signs in the language(s) of the local population? B1.2.2
Is access restricted in controlled areas? B1.2.2
Is adequate information provided to visitors entering controlled areas?
Are the parameters governing structural shielding requirements know and documented for all of B1.2.3
the X-ray equipment in the facility?
Were the facility layout and construction approved by appropriate regulatory authorities? B1.3
Have any modifications been made to the facility? B1.3
If modifications have been made to the facility, was a safety assessment performed by a qualified B1.3
expert prior to the modifications being made?
Were shielding calculations performed by a qualified expert? B1.3
Does the facility meet all applicable federal, provincial or territorial regulatory requirements? B1.3
Equipment Requirements
Does the equipment meet all applicable regulatory requirements? B2.1
Was acceptance testing performed on all equipment at time of purchase prior to clinical use? B2.2.4
Were results from acceptance testing used to set baseline values and limits on operational B2.2.4
performance of the X-ray equipment?

82 Safety Code 35
 Equipment Information

Type of Model Serial Date of Weekly

X-ray Equipment Manufacturer Designation Number Manufacture Workload

Equipment Requirements
At time of purchase, did all new, used and refurbished medical equipment confirmed to meet the: B2.1

Radiation Emitting Devices Regulations?

Medical Devices Regulations?
Is existing equipment periodically assessed for the possibility of upgrading to improve safety B2.3
and performance?

Do all equipment meet the necessary construction and performance requirements?

General Requirements B2.5.1

Radiographic Equipment B2.5.2
Radioscopic Equipment B2.5.3
CT Equipment B2.5.4

Have the dose and image quality information for CT equipment been obtained from B2.5.5
the manufacturer or established by a medical physicist?

Are the recommendations for film processing systems followed at the facility?

X-ray Film Storage B3.1.1

Cassette and Screen Maintenance B3.1.2
Darkroom Conditions B3.1.3
Film Processing B3.1.4
Viewboxes Conditions B3.1.5

Is the management of silver containing waste carried out in accordance to provincial and B3.1.4
municipal requirements?

Does the facility perform digital image processing? B3.2

If yes, what types of digital image acquisition systems are used?
CR Systems: ________________________________________
________________________________________
DR Systems: ________________________________________
________________________________________

For the digital imaging systems, is the manufacturer-specified quality control program B3.2
being followed?

Does the facility possess a PACS? If Yes, B3.2.4

(A) is a PACS quality assurance program in place and includes the recommendations
of this Safety Code?
(B) provide a brief description of the system including main components,
network capabilities, and storage capacity.
(C) does the facility have a disaster recovery plan?

Safety Code 35 83
 Reference
Description Yes / No
Subsection

Does the facility perform teleradiology? B3.2.6

If yes, does the facility follow the CAR guidelines for Teleradiology? B3.2.6
Radiation Protection Surveys
Does the facility undergo Radiation Protection Surveys at regular intervals? B5.0
Are copies of past Radiation Protection Survey reports retained and available if needed? B5.1
Do survey reports include all of the necessary information? B5.2
Were there any incidents or accidents at the facility? B5.2
If yes, were incident and/or accident investigation reports prepared?
If yes, were incidents and/or accidents reported to the appropriate federal,
provincial or territorial agencies?
Were safety assessments reviewed or made based on knowledge gained from an incident B5.2
and/or accident at this facility or other similar facilities?
Quality Assurance Program
Is there a documented quality assurance program at this facility? C1.0
Are policies and guidelines developed and available? C1.3.1
Is the establishment of quality control and administrative procedures documented? C1.3.2
C1.3.3
Is equipment used for quality control testing calibrated? C3.0
Is equipment used for daily quality control testing available on-site at the facility? C3.0
Are individuals trained in the proper operation of quality control test equipment? C3.0

Does the facility quality assurance program include the required tests of this Safety Code
or their equivalent?
For Film-based Radiographic Equipment C3.1-C3.6
For Digital Radiographic Equipment C3.1-C3.6
For Radioscopic Equipment C3.1-C3.6
For CT Equipment C3.1-C3.6

Does the facility Quality Assurance program follow the recommended frequency of testing
of this Safety Code?
...for Daily Quality Control Testing C3.1
...for Weekly Quality Control Testing C3.2
...for Monthly Quality Control Testing C3.3
...for Quarterly Quality Control Testing C3.4
...for Semi-Annual Quality Control Testing C3.5
...for Annual Quality Control Testing C3.6

84 Safety Code 35
Appendix VIII:
Radiation Measurement Units

Exposure
Following the lead of the International Electrotechnical
Commission, the air kerma (in gray, Gy) replaces the
exposure (in roentgen, R) as the measure of exposure. The
relationship between the two units is as follows:

1 Gy ~ 115 R 1R ~ 8.73 mGy

1 mGy ~ 115 mR 1 mR ~ 8.73 µGy

Absorbed Dose
The gray (Gy) replaces the rad (rad) as the unit of absorbed
dose. The relationship between the two units is as follows:

1 Gy ~ 100 rad 1 rad ~ 10 mGy

1 mGy ~ 100 mrad 1 mrad ~ 10 µGy

Equivalent Dose
The sievert (Sv) replaces the rem (rem) as the unit of equiv-
alent dose. The relationship between the two units is as
follows:

1 Sv ~ 100 rem 1 rem ~ 10 mSv

1 mSv ~ 100 mrem 1 mrem ~ 10 µSv

Note: m = milli = 10-3; µ = micro = 10-6

Safety Code 35 85
 IEC (2008). International Electrotechnical Commission. Medical
electrical equipment – Part 1-3: General requirements for basic safety
and essential performance – Collateral Standard: Radiation protec-
References tion in diagnostic X-ray, 2nd ed., IEC 60601-1-3.
AAPM (2002). American Association of Physicists in Medicine.
Quality Control in Diagnostic Radiology, AAPM Report No. 74 IPEM (2004). Institute of Physics and Engineering in Medicine.
(Medical Physics Publishing, Madison, Wisconsin). Guidance on the Establishment and Use of Diagnostic Reference
Levels for Medical X-ray Examinations, IPEM Report 88 (Fairmount
AAPM (2005). American Association of Physicists in Medicine. House, York).
Assessment of Display Performance for Medical Imaging Systems,
AAPM On-Line Report No. 03 (American Association of Physicists IPEM(2005). Institute of Physics and Engineering in Medicine.
in Medicine Task Group 18 Imaging Informatics Subcommittee). Recommended Standards for Routine Performance Testing of Diag-
nostic Imaging Equipment, IPEM Report 91 (Fairmount House,
Aldrich JE, Bilawich A, Mayo JR. Radiation Doses to Patients York).
Receiving Computed Tomography Examinations in British
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