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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
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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 .23
8.3 Possible approaches .24
9 Risk management review .25
10 Production and post-production activities.25
10.1 General .25
10.2 Information collection .25
10.3 Information review .27
10.4 Actions .28
Annex A (informative) Identification of hazards and characteristics related to safety .30
Annex B (informative) Techniques that support risk analysis .38
Annex C (informative) Relation between the policy, criteria for risk acceptability, risk
control and risk evaluation .43
Annex D (informative) Information for safety and information on residual risk .48
Annex E (informative) Role of international standards in risk management .51
Annex F (informative) Guidance on risks related to security .56
Annex G (informative) Components and devices designed without using ISO 14971 .61
Annex H (informative) Guidance for in vitro diagnostic medical devices .63
Bibliography .86
iv © ISO 2020 – All rights reserved
ISO/TR 24971:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organiza
...