International Standard
ISO/TR 24971:2020
Medical devices — Guidance on the application of ISO 14971
Reference number
ISO/TR 24971:2020
Edition 2
2020-06
International Standard
Read sample
ISO/TR 24971:2020
74437
Published (Edition 2, 2020)

ISO/TR 24971:2020

ISO/TR 24971:2020
74437
Language
Format
CHF 216
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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].

In bundle

ISO 13485:2016 + ISO 13485:2016 - Medical devices - A practical guide + ISO 14971:2019 + ISO/TR 24971:2019
ISO 13485:2016 ISO 13485:2016 59752 173 ISO 13485:2016 - Medical devices - A practical guide ISO 13485:2016 - Medical devices - A practical guide pub100484 96 ISO 14971:2019 ISO 14971:2019 72704 173 ISO/TR 24971:2020 ISO/TR 24971:2020 72704 216
Bundle
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

General information

  •  : Published
     : 2020-06
    : International Standard published [60.60]
  •  : 2
     : 87
  • ISO/TC 210
    11.040.01 
  • RSS updates

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