ISO TR 24971:2020

Medical devices - Guidance on the application of ISO 14971

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.

Dispositifs·médicaux — Directives relatives à l'ISO 14971

General Information

• Status: Published
• Publication Date: 15-Jun-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 1 - TC 62/SC 62A/JWG 1
• Current Stage: PPUB - Publication issued
• Start Date: 30-Jul-2020
• Completion Date: 19-Jun-2020

Relations

• Revises: ISO TR 24971:2013 - Medical devices -- Guidance on the application of ISO 14971
• Effective Date: 05-Sep-2023

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 24971
Second edition
2020-06
Medical devices — Guidance on the
application of ISO 14971
Dispositifs médicaux — Recommandations relatives à l'application de
l'ISO 14971
Reference number
ISO/TR 24971:2020(E)
©
ISO 2020

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ISO/TR 24971:2020(E)

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© ISO 2020
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ii © ISO 2020 – All rights reserved

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ISO/TR 24971:2020(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements for risk management system . 1
4.1 Risk management process . 1
4.2 Management responsibilities . 1
4.2.1 Top management commitment . 1
4.2.2 Policy for establishing criteria for risk acceptability . 2
4.2.3 Suitability of the risk management process . 2
4.3 Competence of personnel . 2
4.4 Risk management plan . 3
4.4.1 General. 3
4.4.2 Scope of the risk management plan . 4
4.4.3 Assignment of responsibilities and authorities . 4
4.4.4 Requirements for review of risk management activities . 4
4.4.5 Criteria for risk acceptability . 4
4.4.6 Method to evaluate overall residual risk and criteria for acceptability . 5
4.4.7 Verification activities . 5
4.4.8 Activities related to collection and review of production and post-
production information . 5
4.5 Risk management file .
...