A Practical Guide to IEC 60601

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RIGEL MEDICAL

CONTENTS
03 Foreword 16 Appendix A - IEC 60601-1
test limits
04 Introduction to IEC 60601
17 Appendix B - IEC 60601
04 Local adaptation body model

05 Commonly used
17 Appendix C - IEC 60601
definitions within IEC
test standards (Table 1)
60601
18 Appendix D - IEC 60601
06 Symbols and markings
test standards (Table 2)
07 Visual inspection
24 Appendix E - Patient
07 Ground bond (ground environment
continuity) testing
25 Products in the Rigel
08 Leakage measurements Medical range

10 IEC 60601-1 body model 26 Accessories and services

from Rigel Medical
10 Single fault condition

10 Ground leakage test

11 Enclosure leakage test

12 Patient leakage

13 Patient leakage F-Type

13 Patient auxiliary current © Copyright 2019 - All rights reserved. Nothing from
this edition may be multiplied, or made public in any
form or manner, either electronically, mechanically, by
14 Record keeping photocopying, recording, or in any manner, without
prior written consent from Seaward Electronic Ltd. This
also applies to accompanying drawings and diagrams.
14 Conclusion

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 A PRACTICAL GUIDE TO IEC 60601

Rigel Medical: Foreword

We know about This booklet is written as a guideline for

people involved in testing medical electrical

complying to IEC equipment and cannot be considered to

replace the IEC 60601-1 standard.

60601-1. Although all reasonable care has been taken

to ensure accuracy of the information and
After reading this booklet, so reference figures and data have been taken
will you. from the latest versions of various standards,
guidance notes and recognized ‘best practices’
At Rigel Medical, we’ve been a pioneer to establish the recommended testing
of biomedical test and measurement requirements, Rigel Medical, their agents and
instruments for more than four decades. distributors, accept no responsibility for any
error or omissions within this booklet, or for
Our comprehensive range of electrical safety any misinterpretations by the user.
analyzers enable biomedical and clinical
engineers to confirm their adherence to a For clarification on any part of this booklet
series of industry standards, manufacturers’ please contact Rigel Medical before operating
specifications and most importantly, keep any test instrument.
patients, visitors, and staff safe in a healthcare
environment. No part of this publication shall be deemed to
form, or be part of any contract for training or
Since launching the world’s first IEC 601 equipment unless specifically referred to as an
electrical safety analyzer in the 1970s, our inclusion within such contract.
user-focused developments continue to place
us at the forefront of the industry. Today, our Rigel Medical assumes that the readers of
288+ handheld electrical safety tester (testing this booklet are electronically technically
to IEC 60101) is the first truly handheld competent and therefore does not accept
tester of its kind to combine the features any liability arising from accidents or fatalities
of an automatic/manual tester with asset resulting directly or indirectly from the tests
management capability. described in this booklet.

Alongside our commitment to quality, we also Author: John Backes, MA

offer peace of mind to our customers who
know that help and advice is always available.

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Introduction to IEC 60601 then referred to as IEC 601, and handles

the electrical safety of both mechanical and
electrical issues. It is constructed from 2 parts;
Not all people will understand the dangers
IEC 60601-1 and IEC 60601-2, each built-up
associated with the exposure to electricity.
from a number of basic or collateral standards.
It is this danger that has triggered several
discussions relating to the safety of all
Collateral standard
members of the public.
IEC 60601-1-x (x representing a collateral
standard number between 1-12) is the
Regulatory bodies worldwide have
collateral standard; this is the primary standard
acknowledged the dangers of electricity
which has a number of specific standards
by producing legislation, standards and/or
related directly to the safety of medical
guidelines to control the design of electrical
equipment.
appliances in order to prevent any hazard to
the general public.
Specific standards
One environment where electric currents pose IEC 60601-2-x (x representing a specific
an acute threat is in the medical treatment standard number between 1-76), are the
and care of patients. Often, patients are standards specific to various types of medical
physically connected to one or more electrical equipment, providing additional information
medical devices for a period of time. In these to the collateral standards. Appendix C and D
circumstances it is possible that patients provide an overview of the IEC 60101-1- x and
are unaware of their exposure to electrical IEC 60601-2- x standards.
currents, especially if being treated under full
or local anesthetic. During invasive treatments, This booklet describes the electrical safety
the human body’s natural protection organ, requirements for compliance with IEC 60601-1.
the skin, no longer provides basic insulation Although a type of test standard, most of these
against electrical currents. It is during these tests are used to test medical devices, both
treatments that electrical currents, as low as regularly and following service or repair.
50mA, can travel through the human body
and cause the heart to fibrillate or paralyze the
respiratory system.
Local adaptation
In many cases the IEC 60601 standard has
The International Electrotechnical Committee
been adapted into local standards for use in
(IEC) has produced a standard to control all
countries around the world. Some examples
aspects of safety directly or indirectly relating to
are EN 60601 (EU), ANSI/AAMI ES60601
the handling, use or connection to, of medical
(USA), UL60601-1 (USA), CSA C22.2 no 60601-
equipment. This standard is referenced as IEC
1 (Canada), JIS T 0601-1 (Japan) and AS/NZ
60601.
60601.1 (Australia/New Zealand).
The IEC 60601 was first published in 1977,
Safety testing at the design stage and at the

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 A PRACTICAL GUIDE TO IEC 60601

end of the production line is vitally important, requirements. In essence, all standards have
but what about when the equipment enters one thing in common: to control the safety of
service? medical devices for use in the treatment, care
and diagnosis of patients and/or individuals.
IEC 62353 Medical Electrical Equipment
- Recurrent Test and Test After Repair of
Medical Equipment equipment defines the
Commonly used
requirements for electrical safety testing of definitions within
medical electrical (ME) equipment and systems
during routine intervals.
IEC 60601
Equipment under test (EUT)
Following the need for a unified approach to
The equipment which is the subject of testing.
routine testing, the first edition of IEC 62353
brought together a set number of tests to allow
Device under test (DUT)
its users to test means of operator protection
The device which is the subject of testing.
(MOOP) and means of patient protection
(MOPP) dielectric integrity via two distinct
Applied part
leakage current tests.
Part of the medical equipment which is
In meeting this requirement the IEC 62353 designed to, or likely to, come into physical
incorporates tests beyond those of type testing. contact with the patient e.g. EKG leads.
Specifically, it seeks to provide a uniformed and
unambiguous means of assessing the safety Patient connection
of medical equipment, while maintaining the Individual physical connections and/or metal
relevance to IEC 60601-1 and minimizing the parts intended for connection with the patient
risks to the person conducting the assessment. which form (part of) an applied part.

Some countries have also produced standards Patient environment

or guidelines for the safety testing of newly- Volumetric area in which a patient can come
delivered medical devices, referred to as into contact with medical equipment or
acceptance testing; testing during regular contact can occur between other persons
intervals, referred to as preventive maintenance touching medical equipment and the patient,
tests; and testing following service or repair. both intentionally and unintentionally (see
Some examples are DIN VDE 0751 (Germany), Appendix E).
AS/NZ 3551 (Australia/New Zealand), and AAMI/
NFPA 99 (USA). F-Type applied part
Applied part which is electrically isolated
Countries without a national guidance or code from Ground and other parts of the medical
of practice mainly follow the manufacturer’s equipment i.e. floating F-Type applied parts are
instructions or guidelines, which most either type BF or type CF applied parts.
commonly refer to the IEC 60601-1 test

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Type B applied part insulation through means of connecting

Applied part complying with specified exposed conductive parts to the protective
requirements for protection against electric Ground in the fixed wiring of the installation.
shock. Type B applied parts are those parts,
which are usually Ground referenced. Type B Class II
applied parts are those parts not suitable for Also referred to as ‘double insulated’.
direct cardiac application. Equipment protection against electric shock
by additional protection to basic insulation
Type BF applied part through supplementary insulation. There is
F-Type applied part complying with a higher no provision for the connection of exposed
degree of protection against electric shock metalwork of the equipment to a protective
than type B applied parts. Type BF applied conductor and no reliance upon precautions to
parts are those parts not suitable for direct be taken in the fixed wiring of the installation.
cardiac application.

Type CF applied part Note: Class II equipment may be provided

F-Type applied part complying with the highest with a functional Ground terminal or a
degree of protection against electric shock. functional Ground conductor.
Type CF applied parts are those parts suitable
for direct cardiac application.

Medical electrical equipment

Symbols and markings
Electrical equipment designed for treatment,
The IEC 60601 has defined the requirements
monitoring or diagnoses of patients, powered
for information/data to be present on the
from one connection to mains supply. Does not
medical equipment’s nameplate, in order to
necessarily require physical or electrical contact
form an unambiguous identification of the
with the patient, transfer energy to or from the
equipment.
patient, or detect such energy transfer to or
from the patient.
Information must include specific manufacturer
and equipment information, including
Medical electrical system manufacturer’s name, model number, serial
A combination of equipment of which at least number, and electrical requirements.
one is classed as medical electrical equipment
and is specified by the manufacturer to be The IEC 60601 standard refers to a large variety
connected by functional connection or use of a of symbols for use on medical equipment,
multiple portable socket outlet. medical systems, accessories and other related
parts. A full overview of the symbols used in
Class I IEC 60601 is provided in the standard. For the
Equipment protection against electric shock purpose of this booklet, a selection of the most
by (Grounded) additional protection to basic

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 A PRACTICAL GUIDE TO IEC 60601

commonly used symbols is displayed below: ∙∙ Housing enclosure – look for damage, cracks
etc.
∙∙ Contamination – look for obstruction of
Class I Class II moving parts, connector pins etc.
∙∙ Cabling (supply, applied parts etc.) – Look
for cuts, wrong connections etc.
Ground i.e. ∙∙ Fuse rating – check correct values after
reference “Conformité replacement
point Européenne” ∙∙ Markings and labeling – check the integrity
of safety markings
Type B Defibrillation ∙∙ Integrity of mechanical parts – check for any
applied proof type B obstructions
part applied part

Type BF Defibrillation Ground bond (Ground

applied
part
proof type BF
applied part
Continuity) Testing
Ground bond testing, also referred to as Ground
Type CF Defibrillation
resistance, Ground continuity or protective
applied proof type CF
Ground testing, tests the integrity of the low
part applied part
resistance connection between the Ground
conductor and any metal conductive parts,
Visual inspection which may become live in case of a fault on
Class I medical devices.
The process of visual inspection is not
clearly defined by IEC 60601, however visual Although many Class I medical devices are
inspections form a critical part of the general supplied with a ground reference point, most
safety inspections during the functional life of medical devices require multiple Ground bond
medical equipment. Around 70% of all faults tests to validate the connections of additional
are detected during visual inspection. metal accessible parts on the enclosure.

Visual inspection is a relatively easy procedure The test current is applied between the
to support your assessment that the medical Ground pin of the mains supply plug and any
equipment in use still conforms to the accessible metal part, including the Ground
specifications as released by the manufacturer reference point, with a dedicated Ground bond
and has not suffered from any external damage test lead using a crocodile clip or probe.
and/or contamination.
The IEC 60601-1 (clause 8.6.4) requires a
These can include the following inspections: minimum test current of either 25A AC or 1.5
times the highest rated current of the relevant

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circuit(s), whichever is greater. The open circuit that current, not voltage, is often the source of
voltage of the current source should not exceed injury or death.
6V.
When an electrical current flows through the
A test current of 25A AC is most commonly human body the effect is influenced by two
used. Due to the exposure of high current, main factors: First, the amount of current, and
some parts of the equipment could be secondly, the length of time the current flows.
damaged and therefore requires a lower test
current. However, the Ground bond test is For example, the heart stops if the current
designed to stress the connection under fault persists for 250mS at 40mA, 100mS at 100mA,
conditions. or 50mS at 200mA.

Faults in the detachable power cord account Consider the following examples of the effect
for 80-90% of all Ground bond failures, as most of current on the human body when applied to
molded power cables are prone to stress when the skin (non-invasive):
the cables are pulled from wall outlet at an
angle or otherwise stressed.
0.9-1.2mA Current just perceptible.
For fixed installations, such as MRI or x-ray
equipment) a point-to-point continuity 15.0-20.0mA Release impossible. Cannot be
measurement can be made. The resistance tolerated over 15 minutes.
is then measured between two probes: one
connected to the incoming ground reference 50.0-100.0mA Ventricular fibrillation.
point and one placed on accessible, metal parts Respiratory arrest, leading directly to death.
of the medical installation.
100.0-200.0mA Serious burns and muscular
Test limits are set at 0.1Ω for fixed power cords contraction of such a degree that the
and 0.2Ω for equipment with a detachable thoracic muscles constrict the heart.
power cord. See Appendix A for a full overview
of the IEC 60601-1 test limits.
Compare these values to the fact that 250mA
Prolonged use of testing at high currents can of current is required to power a 25 watt lamp.
lead to a high probe temperature. Care should
be taken to avoid touching the probe tip under For this reason, the IEC 60601 committee has
these conditions. set stringent rules on the design of medical
equipment to prevent any patient or operator
being exposed to currents not part of the
Leakage measurements functional operation of the device. These
currents are referred to as leakage currents.
It takes only a small amount of current to cause
major consequences. Research has shown IEC 60601 defines leakage current of three

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 A PRACTICAL GUIDE TO IEC 60601

different sources: the probability of ventricular fibrillation to a

factor as low as 0.002 – the limit of 10 μA for
Ground leakage: current flowing down the CF applied part under normal condition. See
protective Ground conductor of the mains inlet Appendix A for a full overview of the
lead. IEC 60601-1 test limits.

Enclosure leakage: current flowing to Ground The following tests find their origin from the
through a person by touching the medical IEC 60601-1 but are specific to the AAMI and
equipment/system or part of (may be referred NFPA 99 standards (USA):
to as touch leakage).
∙∙ Patient leakage (applied part to ground):
Applied part or patient leakage: current Similar to patient leakage (see description
flowing through a person to Ground from above).
the applied part, or current flowing from a ∙∙ Patient leakage (applied part to case):
person to Ground through the applied part by Similar to patient leakage (see description
applying unintended voltage from an external above) with leakage current path coming
source. from the applied parts, through the patient,
to the casing of the EUT/DUT.
Applied part/patient leakage can be classed ∙∙ Patient Auxiliary (applied part to applied
into number of measurements such as: part or lead to lead): Similar to patient
auxiliary current (see description above).
∙∙ Patient leakage (please refer to the ∙∙ Patient Auxiliary (applied part to all):
corresponding paragraph) Similar to patient auxiliary current (see
∙∙ Patient F-Type leakage (please refer to the description above). For the purpose of this
corresponding paragraph) booklet, the focus will be on the directly
∙∙ Patient auxiliary leakage (please refer to the related leakage measurements as per IEC
corresponding paragraph) 60601-1.

Applied part or patient leakage is the most

Warning:
important part of leakage measurement on
Mains voltage applied to appliance.
any medical device. Applied parts are directly
It is important to verify that a medical
in contact with the patient or, in the case of
device with moving parts (such as a motor
invasive devices, placed under the patient’s
or pump) is safely mounted to allow
skin. Currents applied under the skin, which
movement, without causing damage to
forms our natural protection against electrical
people or equipment. Secondary Ground
currents, can result in far greater consequences,
paths will effect the leakage measurements
with currents as low as 15μA resulting in
and can give false PASS readings. Always
fatality.
make sure that the device under test is
positioned safely and isolated from Ground
The limits for leakage currents within the IEC
when measuring leakage.
60601-1 requirements are set to minimizing

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IEC 60601-1 body model normal and single fault conditions. A typical
part of the electrical safety testing procedures is
to perform the test as follows:
To ensure a traceable simulation of current as if
passing through a human body, measurement
1. Normal supply voltage (No SFC)
circuits have been designed to simulate the
2. Normal supply voltage (Open neutral)
average typical electrical characteristics of the
3. Normal supply voltage (Open Ground)
human body. These measurement circuits
4. Reversed supply voltage (No SFC)
are referred to as body models or measuring
5. Reversed supply voltage (Open neutral)
devices (MD in IEC 60601-1).
6. Reversed supply voltage (Open Ground)

Some standards such as the AAMI/NFPA 99

In addition to these tests, some manufacturers
and the IEC 61010 (Safety requirements for
may choose to include voltage on the signal
electrical equipment for measurement, control,
input/output terminals (i.e. communication
and laboratory use) specify different electrical
ports such as USB or RS 232). As this test
characteristics to that of the IEC 60601-1.
can be destructive, it is not commonly used
other than during type testing of the medical
The IEC 60601-1 body model or measuring
electrical equipment.
device is shown in Appendix B.

Single fault condition Ground leakage test

The Ground leakage test shows the current
To maintain a medical device’s high level
flowing through the medical device or
of protection during its operational life and
its insulation into the protective Ground
maintain the integrity of the device’s electrical
conductor. The Ground leakage test is
safety, a number of design features are taken
important as it demonstrates the total leakage
into account. This is done by introducing
from the EUT/DUT.
conditions that could occur under normal use,
such as reversed mains supply or voltage on
IEC 60601-1 specifies that the measurements
signal input/output terminals (SIP/SOP), and
are done under normal and reverse operation
conditions that can occur under a single fault
and single fault condition (neutral open circuit).
condition (SFC).
The Ground leakage test is valid for Class I
equipment with Type B, Type BF and Type CF
IEC 60601-1 specifies a number of single fault
applied parts. Appendix A shows the pass/fail
conditions (SFCs) under its clause 8.1. For the
limits as per IEC 60601-1 requirements.
purpose of this booklet, the only highlighted
SFCs are the interrupted Ground connection
(open Ground) and interruption of any of the
supply conductors (open neutral).
IEC 60601-1 specifies that all leakage
measurements should be carried out using

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 A PRACTICAL GUIDE TO IEC 60601

IEC 60601-1 specifies that the measurements

Note: SFC ‘open Ground’ cannot be are done under normal and reverse operation
performed as this would result in of the mains supply and single fault conditions
zero leakage measurements under all open neutral circuit and open Ground. The
circumstances.individual. enclosure leakage test is valid for both Class
I and II equipment with Type B, Type BF and
Type CF applied parts. Appendix A shows the
Diagram A shows a schematic interpretation
pass/fail limits as per IEC 60601-1 requirements.
of the Ground leakage measurement including
the relays operating the single fault conditions.

Note: For Class II equipment, the single fault

Ground open tests are not required.

In the case of Class II devices, or fully insulated

enclosures, this can be encapsulated by using
aluminum foil of approximately 200 cm2. The
enclosure leakage is measured by connecting
Diagram A – Test circuit for Ground leakage
the aluminum foil to the leakage tester.

Ground leakage, normal conditions This test Diagram B shows a schematic interpretation
measures the Ground leakage current under of the Ground leakage measurement including
normal conditions. The current is measured the relays operating the single fault conditions.
through the measuring device with S1 closed,
S5 normal, and then S5 reversed.

Ground leakage, single fault, supply open

This test measures the Ground Leakage current
with a single fault condition (supply open). The
current is measured through the measuring
device with S1 open, S5 normal, and then S5
reversed.

Enclosure leakage test

Diagram B - Test circuit for enclosure leakage

Enclosure leakage, normal condition This test

In general, enclosure leakage displays the measures the enclosure leakage current under
current that would flow if a person came into normal conditions. The current is measured
contact with the housing (or any accessible through the measuring device with S1 and S8
part not intended for treatment or care) of the closed and S5 normal and reversed.
medical device.

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Enclosure leakage, single fault, supply open separately. However, for Type B and Type BF
This test measures the enclosure leakage equipment, the patient leakage current is
current with a single fault condition (Ground measured with all applied parts connected
open). The current is measured through the together.
measuring device with S1 open, S8 closed and
S5 in normal and then S5 reversed. Diagram C shows a schematic interpretation
of the patient leakage measurement, including
Enclosure leakage, single fault, Ground open the relays operating the single fault conditions.
This test measures the enclosure leakage
current with a single fault condition (Ground
open). The current is measured through the
measuring device with S1 closed, S8 open and
S5 in normal and then S5 reversed.

Patient leakage
The patient leakage current is the current
flowing from the applied part via the patient
Diagram C - Test circuit for patient leakage current
to Ground, or flowing from the patient via an
applied part to Ground originating from an Patient leakage, normal condition This test
unintended voltage appearing on an external measures the patient leakage current under
source. normal conditions. The current is measured
through the measuring device with S1 and S8
IEC 60601-1 specifies that the measurements
closed, S5 normal, and then S5 reversed.
must be done under normal and reverse
operation of the mains supply and single fault Patient leakage, single fault, supply open
conditions open neutral circuit and open This test measures the patient leakage current
Ground. The patient leakage test is valid for with a single fault condition (Ground open). The
both Class I and Class II equipment with Type current is measured through the measuring
B, Type BF and Type CF applied. device with S1 closed, S8 open, S5 normal, and
then S5 reversed.
Appendix A shows the pass/fail limits as per IEC
60601-1 requirements. Patient leakage, single fault, Ground open
This test measures the patient leakage current
with a single fault condition (Ground open). The
Note: For Class II equipment, the single fault current is measured through the measuring
Ground open tests are not required. device with S1 closed, S8 open, S5 normal, and
then S5 reversed.

For Type CF equipment the patient leakage

current is measured from each applied part

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Patient leakage: F-Type

The patient leakage F-Type Test (also known as
mains on applied part test) displays the current
that would flow if a mains potential was
applied to the applied part which was attached
to a patient (i.e. a single fault condition). This
test is applied only to Type BF and Type CF
equipment.

This test involves applying a current limited Diagram D - Test circuit for patient leakage current mains on
mains potential (110% of mains input voltage) applied part

to the applied part connections. Due to

The current is measured through the
the requirements for IEC 60601-1, this test
measuring device with S1 and S8 closed. S5
current can be in excess of 5mA under short
and S9 are switched between normal and
circuit conditions, and is therefore hazardous
reversed.
to the user. Caution should be taken when
conducting this test. Current limiting is
achieved with a limiting resistor in series with Patient auxiliary current
the measurement circuit.
The patient auxiliary current displays the
IEC 60601-1 specifies that leakage current leakage current that would flow between
for Type CF applied parts is measured from applied parts under normal and fault
each of the patient connection/applied parts conditions. For these tests, current is measured
separately. For Type BF equipment, the leakage between a single part of the applied part and
current is measured with all parts of the same all other applied parts connected together. This
type of applied part connected together, shown test should be repeated until all combinations
in Diagram D. have been tested. This is also referred to as
applied part to all.
The F-Type leakage test is valid for both Class I
and Class II equipment. It is measured under IEC 60601-1 specifies that the measurements
mains normal or reverse and source voltage be carried out under normal and reverse
normal or reverse conditions. Appendix A operation of the mains supply and single fault
shows the pass/fail limits as per IEC 60601-1 conditions open neutral circuit and open
requirements. Ground. The patient auxiliary leakage test is
valid for both Class I and II equipment with
Diagram D shows a schematic interpretation of Type B, Type BF, and Type CF applied.
the F-Type leakage measurement including the
relays operating the single fault conditions.

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Note: For Class II equipment, the single fault Record keeping

Ground open tests are not required.
There are two paths for tracking preventative
maintenance (PM) activity. First is a manual
Diagram E shows a schematic interpretation data capture process of test data. The other
of the patient auxiliary leakage measurement option is use of a computerized maintenance
including the relays operating the single fault management software (CMMS).
conditions.
Test instrument manufacturers offer test
instruments capable of storing test results for
the subsequent downloading to printers and
digital applications.

Overall, the area of risk assessment and the

creation of risk management files has become
a growing feature of routine safety testing
decisions, with different organizations and
departments drawing-up individual plans to
Diagram E - Test circuit for patient auxiliary current
deal with specific safety hazards.

Patient auxiliary, normal condition This test

For the future, therefore, determining the
measures the patient auxiliary current under
appropriate levels of electrical testing to be
normal conditions. The current is measured
taken without compromising the safety of staff
through the measuring device with S1 and S8
or patients will be central to the introduction
closed, S5 normal, and then S5 reversed.
of cost effective yet reliable preventative
Patient auxiliary, single fault, supply open maintenance campaigns.
This test measures the patient auxiliary
current under a single fault condition (supply Conclusion
open). The current is measured through the
measuring device with S1 open, S8 closed, S5 Electrical safety testing of medical electronic
normal, and then S5 reversed. devices remains a crucial part of the overall
safety validation of medical devices and
Patient auxiliary, single fault, Ground open
requires specialized test equipment.
This test measures the patient auxiliary
current under a single fault condition (ground When choosing your electrical safety analyzer,
open). The current is measured through the make sure it can be used to test in accordance
measuring device with S1 closed, S8 open, S5 with the IEC 60601-1 requirements and
normal, and then S5 reversed. secondly that your analyzer will enable you to
accurately and repeatedly produce the results
you require.

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 A PRACTICAL GUIDE TO IEC 60601

Essential requirements for electrical safety

analyzers are:

∙∙ User safety – this must never be

compromised
∙∙ The measuring device meets the frequency
response of the IEC 60601-1 body model
∙∙ High accuracy and repeatability of
leakage measurement readings. Some
manufacturers may specify accuracy of full
scale reading which will affect the accuracy
of low leakage measurements
∙∙ Traceability of measurement results. Do you
require data storage?
∙∙ Test convenience, including test duration,
user interface, time efficiency

Rigel Medical offers a range of test equipment

in line with the IEC 60601 requirements.

Please visit our website www.rigelmedical.com

for a full overview of our product offering or
register online for our free newsletter on future
product releases and product innovations.

For further questions or comments relating to

this booklet or on the Rigel Medical product
offering, please contact our Rigel team via
email at [email protected]

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Appendix A: IEC 60601-1 test limits

Ground bond test limit at 25A, 50Hz

Non-detachable power cord < 0.1 Ω

Detachable power cord < 0.2 Ω

Type B Type BF Type CF

applied parts applied parts applied parts

Leakage current type NC SFC NC SFC NC SFC

Ground leakage
5000μA 10000μA 5000μA 10000μA 5000μA 10000μA
(4th edition)*

Ground leakage (General) 500µA 1000µA 500µA 1000µA 500µA 1000µA

Enclosure leakage 0.1mA 0.5mA 0.1mA 0.5mA 0.1mA 0.5mA

Patient leakage (dc) 100μA 500μA 100μA 500μA 10μA 50μA

Patient leakage (ac) 100μA 500μA 100μA 500μA 10μA 50μA

Patient leakage (F-Type) NA NA NA 5000μA NA 50μA

Patient leakage
NA 5000μA NA NA NA NA
(mains on SIP/SOP)

Patient auxiliary current

10μA 50μA 10μA 50μA 10μA 50μA
(dc)

Patient auxiliary current

100μA 500μA 100μA 500μA 10μA 50μA
(ac)

* The pass/fail limit for Ground Leakage in the 4th edition of IEC 60601 has been increased from
500μA under normal condition to 5000μA for Class I equipment with NO exposed metal parts
that may become live when a fault appears.

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Appendix B: IEC 60601 body model

z (f = 10)
z (f)

Note: The network and voltage measuring instrument above are replaced by the symbol
in the following figures:

a) Non-inductive components
b) Impedance >> measuring impedance Z
c) Z (f) is the transfer impedance of the network, i.e. V out/in, for a current frequency f

Diagram F - Example of a measuring device according to IEC 60601-1 and its frequency characteristics

Appendix C: IEC 60601 test standards

Table 1 – IEC 60601 Collateral Standards
(© IEC Geneva, Switzerland)

IEC 60601-1
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance

IEC 60601-1-2
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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IEC 60601-1-3
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential
performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

IEC 60601-1-6
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability

IEC 60601-1-8
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems

IEC 60601-1-9
Medical electrical equipment - Part 1-9: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for environmentally conscious design

IEC 60601-1-10
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for the development of physiologic closed-loop
controllers

IEC 60601-1-11
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment

IEC 60601-1-12
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential
performance - Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services environment

Appendix D: IEC 60601 test standards

Table 2 – IEC 60601 Specific Standards
(© IEC Geneva, Switzerland)

IEC 60601-2-1
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential
performance of electron accelerators in the range 1 MeV to 50 MeV

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 A PRACTICAL GUIDE TO IEC 60601

IEC 60601-2-2
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-3
Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave therapy equipment

IEC 60601-2-4
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential
performance of cardiac defibrillators

IEC 60601-2-5
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment

IEC 60601-2-6
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential
performance of microwave therapy equipment

IEC 60601-2-8
Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating in the range 10kV to 1MV

IEC 60601-2-10
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential
performance of nerve and muscle stimulators

IEC 60601-2-11
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential
performance of gamma beam therapy equipment

IEC 60601-2-16
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-17
Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy after loading equipment

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IEC 60601-2-18
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment

IEC 60601-2-19
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential
performance of infant incubators

IEC 60601-2-20
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential
performance of infant transport incubators

IEC 60601-2-21
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential
performance of infant radiant warmers

IEC 60601-2-22
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60601-2-23
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential
performance of transcutaneous partial pressure monitoring equipment

IEC 60601-2-24
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers

IEC 60601-2-25
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential
performance of electrocardiographs

IEC 60601-2-26
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential
performance of electroencephalographs

IEC 60601-2-27
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment

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IEC 60601-2-28
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-29
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators

IEC 60601-2-31
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source

IEC 60601-2-33
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential
performance of magnetic resonance equipment for medical diagnosis

IEC 60601-2-34
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment

IEC 60601-2-36
Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential
performance of equipment for extra corporeally induced lithotripsy

IEC 60601-2-37
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment

IEC 60601-2-39
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment

IEC 60601-2-40
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment

IEC 60601-2-41
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis

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RIGEL MEDICAL

IEC 60601-2-43
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential
performance of X-ray equipment for interventional procedures

IEC 60601-2-44
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography

IEC 60601-2-45
Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential
performance of mammographic X-ray equipment and mammomagraphic stereotactic devices

IEC 60601-2-46
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential
performance of operating tables

IEC 60601-2-47
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential
performance of ambulatory electrocardiographic systems

IEC 60601-2-50
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential
performance of infant phototherapy equipment

IEC 60601-2-52
Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential
performance of medical beds

IEC 60601-2-54
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy

IEC 60601-2-57
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring
and cosmetic/aesthetic use

IEC 60601-2-62
Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential
performance of high intensity therapeutic ultrasound (HITU) equipment

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 A PRACTICAL GUIDE TO IEC 60601

IEC 60601-2-63
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment

IEC 60601-2-64
Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential
performance of light ion beam medical electrical equipment

IEC 60601-2-65
Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment

IEC 60601-2-66
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems

IEC 60601-2-68
Electrical medical equipment - Part 2-68: Particular requirements for the basic safety and
essential performance of X-ray-based image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC 60601-2-75
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential
performance of photodynamic therapy and photodynamic diagnosis equipment

IEC 60601-2-76
Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential
performance of low energy ionized gas haemostasis equipment

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RIGEL MEDICAL

Appendix E: Patient environment

Diagram G – Patient environment

PG 24 TESTED, TRUSTED… WORLDWIDE.

 A PRACTICAL GUIDE TO IEC 60601

Products in the Rigel Medical range

288+
Accurate and fast electrical
safety tester
∙∙ Light, handheld, battery operation*
∙∙ Conforms to IEC 62353 / 60601 / VDE 0751
/ NFPA-99 / AS-NZS 3551
∙∙ Memory for up to 5,000 devices
∙∙ Bluetooth communication
∙∙ Full, semi-automatic and manual testing
∙∙ Straightforward data transfer with the Rigel
288+ Downloader app

SafeTest 50
A cost-effective medical safety
analyzer for general electrical
safety testing
∙∙ Light, handheld, universal AC input
voltage
∙∙ Complies with NFPA-99
∙∙ Large color display
∙∙ Secondary ground warning
∙∙ Manual control of SFC, minimal power
cycling

Download our free Rigel Medical product brochure to see

the full range: www.rigelmedical.com/rigel-downloads

PG 25
RIGEL MEDICAL

Accessories and services from Rigel Medical

Accessories
Having the right accessories can streamline your testing processes and help you get the most from
your instrument. Our range of accessories includes scanners, Bluetooth enabled printers, a variety
of leads and adaptors, pass/fail labels and verification units.

To see the full range of Rigel Medical accessories available, visit www.rigelmedical.com/accessories

Training
Alongside our commitment to quality, we also offer peace of mind to our customers who know
that help and advice is always available. Part of that offering includes training to support and help
you get the most from your instrument.

Contact us directly to find out more.

Online resources & support

At Rigel Medical we take pride in giving you all of the tools to make your life easier. We have a
host of online resources and technical support features on our website including, FAQs, interactive
videos and helpful how-to guides.

www.rigelmedical.com/support

Service, calibration & repair

Rigel Medical can also take care of your test and measurement equipment by providing calibration
services (including on-site calibration), service, spares and repairs. Extend the life and quality of
your instruments by contacting us for a no-obligation quote, wherever you are in the world.

www.rigelmedical.com/service-centre

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 A PRACTICAL GUIDE TO IEC 60601

Notes

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T: +1 813-886-2775 E: [email protected]

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