Medicaldevices-Guidanceonthe applicationofIs014971
Nationalforeword
ISBN 978 0 580 52399 1
ICS 11.040.01
This Published Document is the UK implementation of CEN ISO/TR 24971:2020. It is identical to ISO/TR 24971:2020. Itsupersedes PD ISO/TR 24971:2020 which is withdrawn.
The UK participation in its preparation was entrusted to Technical Committee CH/210/4 Risk analysis for Medical Devices.
A list of organizations represented on this mittee can be obtained onrequest to its mittee manager.
This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.
The British Standards Institution 2020Published by BSI Standards Limited 2020
Compliance with a British Standard cannot confer immunity from legal obligations.
This Published Document was published under the authority of theStandards Policy and Strategy Committee on 30 June 2020.
Amendments/corrigenda issued since publication
Date Text affected31 July 2020 This corrigendum renumbers PD ISO/TR 24971:2020 as PD CEN ISO/TR 24971:2020
English Version
Medical devices-Guidance on the application of ISo 14971 (ISO/TR 24971:2020)
Medizinprodukte - Leitfaden zur Anwendungvon ISO 14971 (1SO/TR 24971:2020)
Dispositifs medicaux - Remandations relativesa l'application de I'ISO 14971 (ISO/TR 24971:2020)
This Technical Report was approved by CEN on 16 July 2020. It has been drawn up by .
CEN and CENELEC members are the national standards bodies and national electrotechnical mittees of Austria Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Republic of North Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary.Macedonia Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey and United Kingdom.
Europeanforeword
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 withTechnical Committee CEN/CLC/JTC 3 *Quality management and corresponding general aspects for medical devices" the secretariat of which is held by NEN.
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 anymodification.
Contents
PageForeword VIntroduction. vi1 Scope. 12 Normative references. 13 Terms and definitions. 14 General requirements for risk management system 4.1 Risk management process 14.2 Management responsibilities. 1 14.2.1 4.2.2 Top management mitment. Policy for establishing criteria for risk acceptability. 1 24.3 Competence of personnel. 4.2.3 Suitability of the risk management process 2 24.4 Risk management plan. 34.4.1 4.4.2 Scope of the risk management plan. General. .3 44.4.3 Requirements for review of risk management activities. Assignment of responsibilities and authorities. 44.4.5 4.4.4 Criteria for risk acceptability. 4 44.4.7 4.4.6 Method to evaluate overall residual risk and criteria for acceptability. Verification activities. 5 44.4.8 production information.. Activities related to collection and review of production and post- 54.5 Risk management file 55 Risk analysis Risk analysis process 65.1 5.2 Intended use and reasonably foreseeable misuse 6 65.4 Identification of characteristics related to safety Identification of hazards and hazardous situations. 7 75.4.1 Hazards 75.4.2 5.4.3 Hazardous situations in general. Hazardous situations resulting from faults. 8 85.4.4 5.4.5 Hazardous situations resulting from systematic faults. Hazardous situations resulting from random faults. 8 85.4.6 Hazardous situations arising from security vulnerabilities. 9 65.5 5.4.7 Risk estimation Sequences or binations of events. 115.5.1 5.5.2 Probability. General. 12 115.5.3 Risks for which probability cannot be estimated. 125.5.4 5.5.5 Examples. Severity 13 136 Risk evaluation. 157 Risk control 157.1 Risk control option analysis. 7.1.1 Risk control for medical device design 15 157.1.2 7.1.3 Standards and risk control Risk control for manufacturing processes 17 187.2 Implementation of risk control measures. 187.3 7.4 Benefit-risk analysis. Residual risk evaluation. 18 187.4.1 General 18
7.4.2Benefit estimation. 19
