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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>BS EN 62366-1:2015+A1:2020 Medical devices Application of usability engineering to medical devices
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immediate downloadReleased: 2020-08-19
BS EN 62366-1:2015+A1:2020 Medical devices Application of usability engineering to medical devices

BS EN 62366-1:2015+A1:2020

Medical devices Application of usability engineering to medical devices

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Standard number:BS EN 62366-1:2015+A1:2020
Pages:60
Released:2020-08-19
ISBN:978 0 580 98164 7
Status:Standard
DESCRIPTION

BS EN 62366-1:2015+A1:2020


This standard BS EN 62366-1:2015+A1:2020 Medical devices is classified in these ICS categories:
  • 11.040.01 Medical equipment in general
  • 11.040 Medical equipment

This part of IEC 62366 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated A1_startwith normal use, i.e., correct use and use errorA1_end. It can be used to identify but does not assess or mitigate risks associated with abnormal use.

A1_start NOTE 1

Safety is freedom from unacceptable risk. Unacceptable risk can arise from use error, which can lead to exposure to hazards including loss or degradation of clinical performance.A1_end

NOTE 2 Guidance on the application of usability engineering to medical devices is available in IEC 62366‑22, which addresses not only safety but also aspects of usability not related to safety.

If the usability engineering process detailed in this International Standard has been complied with, then the usability of a medical device as it relates to safety is presumed to be acceptable, unless there is objective evidence to the contrary.

NOTE 3 Such objective evidence can subsequently originate from post-production surveillance.


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