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

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  07-07-2020

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Abstract - (Show below) - (Hide below)

    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.

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    Committee TC 210
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current
    Supersedes
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