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ANSI/AAMI/IEC 62366-1:2015 (R2021)+AMD1:2020

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

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.

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Association for the Advancement of Medical Instrumentation [aami]

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