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

This document lists possible hazards and contributing factors associated with medical devices according to ISO 14971:2000 Annex D. It identifies hazards relating to energy, mechanical forces, radiation, biology, environment, use of the device, functional failure, maintenance and aging. For each hazard, it indicates whether it is applicable to the medical device being assessed and provides space for comments.

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hamed Iranpour
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82 views

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

This document lists possible hazards and contributing factors associated with medical devices according to ISO 14971:2000 Annex D. It identifies hazards relating to energy, mechanical forces, radiation, biology, environment, use of the device, functional failure, maintenance and aging. For each hazard, it indicates whether it is applicable to the medical device being assessed and provides space for comments.

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

Heat

Mechanical Force

Ionizing Radiation

Non-ionizing Radiation

Electromagnetic Fields

Moving parts

Suspended Masses

Pressure

Acoustic Pressure

Vibration

Biological Hazards Applicable? Comments

Bio-burden / bio-contamination

Bio-incompatibility

Incorrect Output

Toxicity

Cross-infection

Inability to Maintain Hygienic Safety

Degradation

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

Environmental Hazards Applicable? Comments

Electromagnetic Interference

Inadequate Supply of Power or Coolant

Restriction of Cooling

Likelihood of Operation Outside of


Prescribed Environment

Incompatibility with Other Devices


with which it is Intended to be Used

Accidental Mechanical Damage

Contamination Due to Waste Products


and/or Device Disposal

Use of Device Hazards Applicable? Comments

Inadequate Labeling

Inadequate Operating Instructions

Inadequate Specification of
Accessories

Over-complicated Operating
Instructions
Unavailable or Separated Operating
Instructions

Use by Unskilled Personnel

Use by Untrained Personnel

Human Error

Insufficient warning of Side Effects

Inadequate warning of Hazards likely


with Re-use of single use devices
Incorrect Measurements and other
metrological aspects
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Possible Hazards and Contributing Factors associated with medical devices
(ISO 14971:2000, Annex D)

Use of Device Hazards Applicable? Comments

Incorrect Diagnosis

Erroneous Data Transfer

Incompatibility with
consumables/Accessories/Other
Medical Devices

Sharp Edges or Points

Functional Failure, Maintenance and


Applicable? Comments
Aging Hazards

Inadequate performance characteristics


for the intended use

Lack of Specification for Maintenance

Inadequate Maintenance

Inadequate determination of end of


device life

Loss of mechanical/electrical integrity

Inadequate packaging

Re-use and/or improper re-use

Deterioration in function as a result of


repeated use

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