• IEC 62366-1:2015

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical devices - Part 1: Application of usability engineering to medical devices

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  06-20-2020

    Language(s): 

    Published date:  02-24-2015

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2, once published, will contain tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces. The contents of the corrigendum of July 2016 have been included in this copy.

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    Committee TC 62/SC 62A
    Development Note NEW CHILD AMD 1 IS ADDED NOW
    Document Type Standard
    Product Note NEW CHILD AMD 1 IS ADDED NOW
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

    Standards Referencing This Book - (Show below) - (Hide below)

    AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
    SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
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