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CEN ISO/TR 24971:2020

(Main)

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

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].

Medizinprodukte - Leitfaden zur Anwendung von ISO 14971 (ISO/TR 24971:2020)

Dispositifs médicaux - Recommandations relatives à l'application de l'ISO 14971 (ISO/TR 24971:2020)

Le présent document fournit des recommandations relatives au développement, à la mise en œuvre et à la tenue à jour d'un système de gestion des risques pour les dispositifs médicaux conformément à l'ISO 14971:2019.
Le processus de gestion des risques peut faire partie d'un système de management de la qualité qui s'appuie, par exemple, sur l'ISO 13485:2016[24], mais cela n'est pas requis par l'ISO 14971:2019. Certaines exigences de l'ISO 13485:2016 (Article 7 relatif à la réalisation du produit et 8.2.1[eXtyles1]  relatives aux retours d'information au cours de la surveillance et du mesurage) portent sur la gestion des risques et peuvent être satisfaites en appliquant l'ISO 14971:2019. Voir également le manuel ISO: ISO 13485:2016 — Medical devices — A practical guide[25].
[eXtyles1]No section matches the in-text citation "8.2.1". Please supply the missing section or delete the citation.

Medicinski pripomočki - Navodilo za uporabo ISO 14971 (ISO/TR 24971:2020)

General Information

Status
Published
Publication Date
21-Jul-2020
ICS
11.040.01 - Medical equipment in general
Technical Committee
CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
Drafting Committee
CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
22-Jul-2020
Completion Date
22-Jul-2020
Ref Project
SIST-TP CEN ISO/TR 24971:2020 - Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

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SLOVENSKI STANDARD
01-september-2020
Medicinski pripomočki - Navodilo za uporabo ISO 14971 (ISO/TR 24971:2020)
Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Medizinprodukte - Leitfaden zur Anwendung von ISO 14971 (ISO/TR 24971:2020)
Dispositifs médicaux - Directives relatives à l'ISO 14971 (ISO/TR 24971:2020)
Ta slovenski standard je istoveten z: CEN ISO/TR 24971:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN ISO/TR 24971
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2020
ICS 11.040.01
English version
Medical devices - Guidance on the application of ISO 14971
(ISO/TR 24971:2020)
Dispositifs médicaux - Recommandations relatives à Medizinprodukte - Leitfaden zur Anwendung von ISO
l'application de l'ISO 14971 (ISO/TR 24971:2020) 14971 (ISO/TR 24971:2020)

This Technical Report was approved by CEN on 16 July 2020. It has been drawn up by the Technical Committee CEN/CLC/JTC 3.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. CEN ISO/TR 24971:2020 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TR 24971:2020) has been prepared by Technical Committee ISO/TC 210
"Quality management and corresponding general aspects for medical devices" in collaboration with
Technical Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for
medical devices” the secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of ISO/TR 24971:2020 has been approved by CEN as CEN ISO/TR 24971:2020 without any
modification.
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
ISO/TR 24971:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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 . 5
5 Risk analysis . 6
5.1 Risk analysis process . 6
5.2 Intended use and reasonably foreseeable misuse . 6
5.3 Identification of characteristics related to safety . 7
5.4 Identification of hazards and hazardous situations . 7
5.4.1 Hazards . 7
5.4.2 Hazardous situations in general . 8
5.4.3 Hazardous situations resulting from faults . 8
5.4.4 Hazardous situations resulting from random faults . 8
5.4.5 Hazardous situations resulting from systematic faults . 8
5.4.6 Hazardous situations arising from security vulnerabilities . 9
5.4.7 Sequences or combinations of events . 9
5.5 Risk estimation .11
5.5.1 General.11
5.5.2 Probability .12
5.5.3 Risks for which probability cannot be estimated .13
5.5.4 Severity .13
5.5.5 Examples .13
6 Risk evaluation .16
7 Risk control .16
7.1 Risk control option analysis .16
7.1.1 Risk control for medical device design .16
7.1.2 Risk control for manufacturing processes .18
7.1.3 Standards and risk control .19
7.2 Implementation of risk control measures .19
7.3 Residual risk evaluation .19
7.4 Benefit-risk analysis .19
7.4.1 General.19
7.4.2 Benefit estimation .20
ISO/TR 24971:2020(E)
7.4.3 Criteria for benefit-risk analysis .21
7.4.4 Benefit-risk comparison.21
7.4.5 Examples of benefit-risk analyses .21
7.5 Risks arising from risk control measures .22
7.6 Completeness of risk control .22
8 Evaluation of overall residual risk .22
8.1 General considerations .22
8.2 Inputs and other considerations .
...

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