Reference number
ISO/TR 24971:2020
© ISO 2024
Technical Report
ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
Edition 2
2020-06
Technical Report
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Published (Edition 2, 2020)

ISO/TR 24971:2020

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Abstract

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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Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ISO 13485:2016
  • ISO 13485:2016 A practical guide
  • ISO 14971:2019
  • ISO/TR 24971:2020
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General information

  • Status
     : Published
    Publication date
     : 2020-06
    Stage
    : International Standard published [60.60]
  • Edition
     : 2
    Number of pages
     : 87
  • Technical Committee :
    ISO/TC 210
    ICS :
    11.040.01 
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