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[25].
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
4.1 Risk management process
4.2 Management responsibilities
4.2.1 Top management commitment
4.2.2 Policy for establishing criteria for risk acceptability
4.2.3 Suitability of the risk management process
4.3 Competence of personnel
4.4 Risk management plan
4.4.1 General
4.4.2 Scope of the risk management plan
4.4.3 Assignment of responsibilities and authorities
4.4.4 Requirements for review of risk management activities
4.4.5 Criteria for risk acceptability
4.4.6 Method to evaluate overall residual risk and criteria for acceptability
4.4.7 Verification activities
4.4.8 Activities related to collection and review of production and post-production information
4.5 Risk management file
5 Risk analysis
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse
5.3 Identification of characteristics related to safety
5.4 Identification of hazards and hazardous situations
5.4.1 Hazards
5.4.2 Hazardous situations in general
5.4.3 Hazardous situations resulting from faults
5.4.4 Hazardous situations resulting from random faults
5.4.5 Hazardous situations resulting from systematic faults
5.4.6 Hazardous situations arising from security vulnerabilities
5.4.7 Sequences or combinations of events
5.5 Risk estimation
5.5.1 General
5.5.2 Probability
5.5.3 Risks for which probability cannot be estimated
5.5.4 Severity
5.5.5 Examples
6 Risk evaluation
7 Risk control
7.1 Risk control option analysis
7.1.1 Risk control for medical device design
7.1.2 Risk control for manufacturing processes
7.1.3 Standards and risk control
7.2 Implementation of risk control measures
7.3 Residual risk evaluation
7.4 Benefit-risk analysis
7.4.1 General
7.4.2 Benefit estimation
7.4.3 Criteria for benefit-risk analysis
7.4.4 Benefit-risk comparison
7.4.5 Examples of benefit-risk analyses
7.5 Risks arising from risk control measures
7.6 Completeness of risk control
8 Evaluation of overall residual risk
8.1 General considerations
8.2 Inputs and other considerations
8.3 Possible approaches
9 Risk management review
10 Production and post-production activities
10.1 General
10.2 Information collection
10.3 Information review
10.4 Actions
Annex A (informative) Identification of hazards and characteristics related to safety
Annex B (informative) Techniques that support risk analysis
Annex C (informative) Relation between the policy, criteria for risk acceptability, risk control and risk evaluation
Annex D (informative) Information for safety and information on residual risk
Annex E (informative) Role of international standards in risk management
Annex F (informative) Guidance on risks related to security
Annex G (informative) Components and devices designed without using ISO 14971
Annex H (informative) Guidance for in vitro diagnostic medical devices
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for risk management system
4.1 Risk management process
4.2 Management responsibilities
4.2.1 Top management commitment
4.2.2 Policy for establishing criteria for risk acceptability
4.2.3 Suitability of the risk management process
4.3 Competence of personnel
4.4 Risk management plan
4.4.1 General
4.4.2 Scope of the risk management plan
4.4.3 Assignment of responsibilities and authorities
4.4.4 Requirements for review of risk management activities
4.4.5 Criteria for risk acceptability
4.4.6 Method to evaluate overall residual risk and criteria for acceptability
4.4.7 Verification activities
4.4.8 Activities related to collection and review of production and post-production information
4.5 Risk management file
5 Risk analysis
5.1 Risk analysis process
5.2 Intended use and reasonably foreseeable misuse
5.3 Identification of characteristics related to safety
5.4 Identification of hazards and hazardous situations
5.4.1 Hazards
5.4.2 Hazardous situations in general
5.4.3 Hazardous situations resulting from faults
5.4.4 Hazardous situations resulting from random faults
5.4.5 Hazardous situations resulting from systematic faults
5.4.6 Hazardous situations arising from security vulnerabilities
5.4.7 Sequences or combinations of events
5.5 Risk estimation
5.5.1 General
5.5.2 Probability
5.5.3 Risks for which probability cannot be estimated
5.5.4 Severity
5.5.5 Examples
6 Risk evaluation
7 Risk control
7.1 Risk control option analysis
7.1.1 Risk control for medical device design
7.1.2 Risk control for manufacturing processes
7.1.3 Standards and risk control
7.2 Implementation of risk control measures
7.3 Residual risk evaluation
7.4 Benefit-risk analysis
7.4.1 General
7.4.2 Benefit estimation
7.4.3 Criteria for benefit-risk analysis
7.4.4 Benefit-risk comparison
7.4.5 Examples of benefit-risk analyses
7.5 Risks arising from risk control measures
7.6 Completeness of risk control
8 Evaluation of overall residual risk
8.1 General considerations
8.2 Inputs and other considerations
8.3 Possible approaches
9 Risk management review
10 Production and post-production activities
10.1 General
10.2 Information collection
10.3 Information review
10.4 Actions
Annex A (informative) Identification of hazards and characteristics related to safety
Annex B (informative) Techniques that support risk analysis
Annex C (informative) Relation between the policy, criteria for risk acceptability, risk control and risk evaluation
Annex D (informative) Information for safety and information on residual risk
Annex E (informative) Role of international standards in risk management
Annex F (informative) Guidance on risks related to security
Annex G (informative) Components and devices designed without using ISO 14971
Annex H (informative) Guidance for in vitro diagnostic medical devices
Bibliography