ISO/TR 24971:2020
Current
The latest, up-to-date edition.
Medical devices — Guidance on the application of ISO 14971
Hardcopy , PDF
English, French
16-06-2020
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
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| DocumentType |
Technical Report
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| Pages |
87
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| 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
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| PublisherName |
International Organization for Standardization
|
| Status |
Current
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| Supersedes |
| Standards | Relationship |
| PD ISO/TR 24971:2020 | Identical |
| CEN ISO/TR 24971:2020 | Identical |
| SA TR ISO 24971:2020 | Identical |
| S.R. CEN ISO/TR 24971:2020 | Identical |
| TR T 24971:2020 | Identical |
| CSA ISO/TR 24971:21 | Identical |
| IS/ISO/TR 24971 : 2020 | Identical |
| ABNT ISO/TR 24971:2022 | Identical |
| UNE-CEN ISO/TR 24971:2020 | Identical |
| UNE-CEN ISO/TR 24971:2025 IN | Identical |
| PD CEN ISO/TR 24971:2020 | Identical |
| 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) |
| CLSI EP39 ED1:2021 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests |
| 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 |
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