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BSI BS EN 62366-1:2015+A1:2020

Medical devices -- Application of usability engineering to medical devices
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BSI BS EN 62366-1:2015+A1:2020

Medical devices -- Application of usability engineering to medical devices

PUBLISH DATE 2020
PAGES 60
BSI BS EN 62366-1:2015+A1:2020

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.

SDO BSI: British Standards Institution
Document Number EN 62366-1
Publication Date Aug. 19, 2020
Language en - English
Page Count
Revision Level 1
Supercedes
Committee CH/62/1
Publish Date Document Id Type View
Aug. 19, 2020 BS EN 62366-1:2015+A1:2020 Consolidated
Jan. 31, 2016 BS EN 62366-1:2015 Consolidated