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

(Consolidated Text), Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1

The amendment included in this consolidated version of ANSI/AAMI/IEC 62366-1:2015 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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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.

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