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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.

Content Provider
Association for the Advancement of Medical Instrumentation [AAMI]

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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.