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Iso tr 24971 2020 medical devices guidance on the application of iso 14971

TECHNICAL REPORT ISO TR Second edition - Medical devices ?? Guidance on the application of ISO Dispositifs médicaux ?? Directives relatives à l'ISO PROOF ÉPREUVE Reference number ISO TR E ? ISO CISO TR E COPYRIGHT PROTECTED DOCUMENT ? ISO All rights reserved Unless otherwise speci ?ed 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 o ?ce CP ? Ch de Blandonnet CH- Vernier Geneva Phone Fax Email copyright iso org Website www iso org Published in Switzerland ii PROOF ÉPREUVE ? ISO ?? All rights reserved CISO TR E Contents Page Foreword Introduction Scope Normative references Terms and de ?nitions General requirements for risk management system Risk management process Management responsibilities Top management commitment Policy for establishing criteria for risk acceptability Suitability of the risk management process Competence of personnel Risk management plan General Scope of the risk management plan Assignment of responsibilities and authorities Requirements for review of risk management activities Criteria for risk acceptability Method to evaluate overall residual risk and criteria for acceptability Veri ?cation activities Activities related to collection and review of production and post- production information Risk management ?le Risk analysis Risk analysis process Intended use and reasonably foreseeable misuse Identi ?cation of characteristics related to safety Identi ?cation of hazards and hazardous situations Hazards Hazardous situations in general Hazardous situations resulting from faults Hazardous situations resulting from random faults Hazardous situations resulting from systematic faults Hazardous situations arising from security vulnerabilities Sequences or combinations of events Risk estimation General Probability Risks for which probability cannot be estimated Severity Examples Risk evaluation Risk control Risk control option analysis Risk control for medical device design Risk control for manufacturing processes Standards and risk control Implementation of risk control measures Residual risk evaluation Bene ?t-risk analysis General Bene ?t estimation ? ISO ?? All rights reserved PROOF ÉPREUVE iii CISO TR E Criteria for bene ?t-risk analysis Bene ?t-risk comparison Examples of bene ?t-risk analyses Risks arising from risk control measures Completeness of risk control Evaluation of overall residual risk General considerations Inputs and other considerations Possible approaches Risk management review Production and post-production activities General Information collection Information review Actions Annex A informative Identi ?cation 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 Annex H informative Guidance for in vitro diagnostic medical