TECHNICAL REPORT
applicationofISO14971 Medicaldevices-Guidanceonthe
Dispositifs medicaux - Remandations relatives α I'application deIISO 14971
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ISO 2020
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Contents
Page
Foreword.Introduction. vi1 Scope 12 Normative references. 13 Terms and definitions. 14 Generalrequirements for risk management system. 4.1 Riskmanagement process 14.2 Management responsibilities. 14.2.1 4.2.2 Policy for establishing criteria for risk acceptability. Topmanagement mitment.. 1 24.3 Competence of personnel. 4.2.3 Suitability of the riskmanagement process 24.4 Riskmanagement plan 2 34.4.1 4.4.2 Scope of therisk management plan General. 3 44.4.3 Requirementsforreviewof riskmanagement activities. Assignment of responsibilities and authorities. 44.4.5 4.4.4 Criteria for risk acceptability. 4 44.4.6 4.4.7 Method to evaluate overall residual risk and criteria for acceptability Verification activities. 5 54.4.8 productioninformation. Activities related to collection and review of production and post-4.5 Riskmanagementfile 5 55 Risk analysis 65.2 5.1 Risk analysisprocess Intendeduseandreasonablyforeseeablemisuse 6 65.3 5.4 Identification of characteristicsrelated to safety Identification of hazards and hazardoussftuations. 7 75.4.1 Hazards 75.4.2 5.4.3 Hazardous situations in general Hazardous sftuationsresulting from faults. 8 85.4.5 5.4.4 Hazardous sftuations resulting from randomfaults. Hazardous situations resulting from systematic faults. 85.4.6 Hazardous situations arising from security vulnerabilities. 8 95.5 Riskestimation 5.4.7 Sequences or binations of events. 11 95.5.1 5.5.2 General. Probability. 11 125.5.3 Risks for which probability cannot be estimated. 135.5.4 5.5.5 Examples. Severity 13 136 Risk evaluation. 167 Risk control. 167.1 Risk control option analysis. 7.1.1 Risk controlformedical device design 16 167.1.2 7.1.3 Standards and risk control Risk control formanufacturing processes 19 187.2 Implementation of risk control measures. 197.3 7.4 Benefit-risk analysis. Residual risk evaluation.... 19 197.4.1 General. 197.4.2 Benefit estimation.. 20
7.4.3 7.4.4 Benefit-risk parison. Criteria for benefit-risk analysis 21 21Risks arising from risk control measures. 7.4.5 Examples of benefit-risk analyses. 217.5 22
7.6 Completeness of risk control .228 Evaluation of overallresidual risk. 228.2 8.1 General considerations. Inputs and other considerations.. 22 238.3 Possible approaches. 249 Risk management review. 2510 Production and post-production activities. 10.1 General. 25 .2510.2 10.3 Information collection. Information review. .25 .2710.4 Actions. .28Annex A (informative) Identification of hazards and characteristics related to safety. 30Annex B (informative) Techniques that support risk analysis. 38Annex C (informative) Relation between the policy criteria for risk acceptability risk controlandrisk evaluation. 43Annex D (informative) Informationforsafety and information onresidual risk 48Annex E (informative) Role of intermational standards in risk management. 51Annex F (informative) Guidance on risks related to security 56Annex G (informative) Components and devices designed without using ISo 14971. 61Annex H (informative) Guidance forin vitro diagnostic medical devices. 9Bibliography 86
Foreword
bodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISo technical mittees. Each member body interested in a subject for which a technical mittee has been established has the right to be represented on that mittee. InternationalISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of organizations governmental and non-governmental in liaison with ISo also take part in the work.electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance aredescribed in the ISO/IEC Directives Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with theeditorial rules of the ISO/IEC Directives Part 2 (see
Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights.ISO shall not be held responsible for identifying any or all such patent rights.Details of any patent rights identified during the development of the document will be in the Introduction and/oron the ISo list of patent declarations received (see
Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.
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corresponding general aspects for medical devices and Submittee IEC/SC 62A Common aspects ofelectrical equipment used in medicol practice.
This second edition cancels and replaces the first edition which has been technically revised. The main changes pared to the previous edition are as follows:
The clauses of ISO/TR 24971:2013 and some informative annexes of ISO 14971:2007 are merged restructured technically revised and supplemented with additional guidance.-To facilitate the use of this document the same structure and numbering of clauses and subclausesas in ISO 14971:2019 is employed. The informative annexes contain additional guidance on specific aspects of risk management.
plete listing of these bodies can be found at
