ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)
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ANSI/AAMI/IEC 62366-1:2015/(R)2021+AMD1:2020 (Consolidated Text)

Medical devices—Part 1: Application of usability engineering to medical devices + Amendment 1

Summary

ANSI/AAMI/IEC 62366, Part 1 was updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2019 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Amendment 1, included in this consolidated version of ANSI/AAMI/IEC 62366-1:2015/(R)2021 and ANSI/AAMI/IEC 62366-1:2015/A1:2020, corrects identified inaccuracies in ANSI/AAMI/IEC 62366-1:2015 while making no fundamental changes to the usability engineering process as originally conceived in that document. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2015
Confirmation Date 01/01/2021
Page Count 54
Themes Human factors
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