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ISO/TR 24971:2020

ISO/TR 24971:2020

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Medical devices — Guidance on the application of ISO 14971

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

16-06-2020

Publisher

International Organization for Standardization

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£211.00
Excluding VAT

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].

Committee
ISO/TC 210
DocumentType
Technical Report
Pages
87
ProductNote
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
PublisherName
International Organization for Standardization
Status
Current
Supersedes

AAMI/ISO/ IEC Guide 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
ISO/DIS 18969:2025 Clinical evaluation of medical devices
I.S. EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
AAMI TIR105:2020 Risk management guidance for combination products
I.S. EN 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
ANSI/AAMI/IEC 62366-1:2015(R2021)+AMD1:2020 Medical devices—Part 1: Application of usability engineering to medical devices, including Amendment 1

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

Frequently Asked Questions

ISO/TR 24971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It is an international standard published by International Organization for Standardization (ISO).

ISO/TR 24971 is used by medical device manufacturers and developers managing product safety risk throughout the lifecycle. It is an international standard published by International Organization for Standardization (ISO).

ISO/TR 24971 is International Organization for Standardization (ISO)'s standard for medical device risk management, while BS EN ISO 14971 covers medical device risk management (United Kingdom). ISO/TR 24971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. BS EN ISO 14971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. It supports consistent specification, verification and documented acceptance across the relevant lifecycle.

ISO/TR 24971 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO/TR 24971 defines or supports a lifecycle process for identifying, evaluating, controlling and monitoring medical device risks. In practice it is applied by medical device manufacturers and developers managing product safety risk throughout the lifecycle.
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Hardcopy - English
PDF - English
Hardcopy - French
PDF - French
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