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  • ISO/TR 24971:2020

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    Medical devices Guidance on the application of ISO 14971

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

    Language(s):  English, French

    Published date:  06-16-2020

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.

    The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019. See also the ISO Handbook: ISO 13485:2016 Medical devices A practical guide[25].

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    Document Type Technical Report
    Product Note THIS STANDARD ALSO REFERS TO :AAMI TIR 57,IEC 62366-1:2015,IEC TR 62366-2,IEC 62502,IEC 80001-1:2010,ISO/IEC Guide 63:2019,ISO/DIS 10017,ISO Handbook: ISO 13485:2016,ISO 14155,ISO 15189,ISO 15197,,ISO/TR 20416
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
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