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Possible Hazards and Contributing Factors Associated With Medical Devices (ISO 14971:2000, Annex D)

This document identifies possible hazards associated with a medical device based on ISO 14971:2000. It lists hazards related to energy, mechanics, biology, environment, use, and maintenance. For each applicable hazard, it notes how the hazard could manifest in the device and any relevant comments. The key hazards identified include heat from sterilization, mechanical forces, biocontamination, use by unskilled personnel, human error, sharp edges, loss of integrity, and deterioration from repeated use.

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hamed Iranpour
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27 views

Possible Hazards and Contributing Factors Associated With Medical Devices (ISO 14971:2000, Annex D)

This document identifies possible hazards associated with a medical device based on ISO 14971:2000. It lists hazards related to energy, mechanics, biology, environment, use, and maintenance. For each applicable hazard, it notes how the hazard could manifest in the device and any relevant comments. The key hazards identified include heat from sterilization, mechanical forces, biocontamination, use by unskilled personnel, human error, sharp edges, loss of integrity, and deterioration from repeated use.

Uploaded by

hamed Iranpour
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Possible Hazards and Contributing Factors associated with medical devices

(ISO 14971:2000, Annex D)

Energy Hazards Applicable? How is the hazard applicable in the device?

Electricity No

Extreme heat conditions may be experienced


Heat Yes
during steam sterilization.
Some of the mechanical forces encountered by
Mechanical Force Yes the device are torque, friction, compression,
tension.

Ionizing Radiation No

Non-ionizing Radiation No

Electromagnetic Fields No

Moving parts of the device includes clamps,


Moving parts Yes screws, nuts and various joints that allows the
device to move in 6 degrees of freedom.

Suspended Masses No

Pressure is applied during tightening of the


Pressure Yes
screws and nuts.

Acoustic Pressure No

Vibration between interference of nuts and


Vibration Yes screws in the construct may be experienced
whenever the device is being moved.

Biological Hazards Applicable? Comments

In order to prevent this hazard, the device has to


Bio-burden / bio-contamination Yes
be cleaned and sterilized for every use.
This hazard is addressed by the type of material
Bio-incompatibility Yes used. In this case, SS304 will be used in
majority of the device’s construct.

Incorrect Output No

Toxicity No

In order to prevent this hazard, the device has to


Cross-infection Yes
be cleaned and sterilized for every use.
The device will be designed to provide access
Inability to Maintain Hygienic Safety Yes
for cleaning.

Degradation No

Page 1 of 3
Possible Hazards and Contributing Factors associated with medical devices
(ISO 14971:2000, Annex D)

Environmental Hazards Applicable? Comments

Electromagnetic Interference No

Inadequate Supply of Power or Coolant No

Restriction of Cooling No

Likelihood of Operation Outside of


No
Prescribed Environment
The parts that we’ll adapt in the device are
Incompatibility with Other Devices
Yes lowman clamp and schanz pin. The device will
with which it is Intended to be Used
be designed to be able to incorporate these.
This can only happen if the welding of some
Accidental Mechanical Damage Yes parts of the device was poorly fabricated and
when too much force is exerted in the device.
Contamination Due to Waste Products
No
and/or Device Disposal

Use of Device Hazards Applicable? Comments

Inadequate Labeling No

The group will provide a surgical technique as


Inadequate Operating Instructions Yes
an operating instruction.
The group will enumerate all necessary
Inadequate Specification of
Yes accessories used with the device in the surgical
Accessories
technique.
Over-complicated Operating
No
Instructions
Unavailable or Separated Operating
No
Instructions

Use by Unskilled Personnel Yes This device is limited to surgeons.

Use by Untrained Personnel Yes This device is limited to surgeons.

Human Error Yes An example of this is doctor's carelessness.

Insufficient warning of Side Effects No

Inadequate warning of Hazards likely


No The device is intended to be re-used.
with Re-use of single use devices
Incorrect Measurements and other
No
metrological aspects

Page 2 of 3
Possible Hazards and Contributing Factors associated with medical devices
(ISO 14971:2000, Annex D)

Use of Device Hazards Applicable? Comments

Incorrect Diagnosis No

Erroneous Data Transfer No

Incompatibility with The parts that we’ll adapt in the device are
consumables/Accessories/Other Yes lowman clamp and schanz pin. The device will
Medical Devices be designed to be able to incorporate these.

Sharp Edges or Points Yes All sharp edges should be deburred.

Functional Failure, Maintenance and


Applicable? Comments
Aging Hazards
Included in the limitations of the device are the
Inadequate performance characteristics
Yes clearances of movable parts and the diameter of
for the intended use
bone that the clamp can hold.
The device is to be cleaned and sterilized for
Lack of Specification for Maintenance Yes
every use.

Inadequate Maintenance Yes

Inadequate determination of end of


No User will be able to determine if the parts wear.
device life

Loss of mechanical/electrical integrity Yes Failure of weld or other components

Inadequate packaging No

Re-use and/or improper re-use Yes Recleaning and resterilization is necessary

Deterioration in function as a result of Wearing of screws, threads and other movable


Yes
repeated use parts.

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