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  • BSI
    BS EN 62366-1:2015+A1:2020 Medical devices - Application of usability engineering to medical devices
    Edition: 2020
    $497.46
    / user per year

Description of BS EN 62366-1:2015+A1:2020 2020

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.



Standard NumberBS EN 62366-1:2015+A1:2020
TitleMedical devices - Application of usability engineering to medical devices
StatusDefinitive
Publication Date2020-08-19
ReplacesBS EN 62366:2008+A1:2015
Identical National Standard OfEN 62366-1:2015/A1:2020, IEC 62366-1:2015/AMD1:2020
AmendsBS EN 62366-1:2015
DescriptorsDesign, Equipment safety, Hazards, Ergonomics, Medical instruments, Instructions for use, Medical technology, Medical equipment
ICS11.040.01 Medical equipment in general, 11.040 Medical equipment
CommitteeCH/62/1
ISBN978 0 580 98164 7
PublisherBSI
Pages60

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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