TECHNICAL REPORT ISO/TR 24971 Second edition 2020-05 Medical devices — Guidance on the application of ISO 14971 Dispositifs médicaux — Directives relatives à l'ISO 14971 PROOF/ÉPREUVE Reference number ISO/TR 24971:2020(E) © ISO 2020 ISO/TR 24971:2020(E)  COPYRIGHT PROTECTED DOCUMENT © ISO 2020 All rights reserved. Unless otherwise specified, 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 office CP 401 • Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved ISO/TR 24971:2020(E)  Contents Page Foreword...........................................................................................................................................................................................................................................v Introduction................................................................................................................................................................................................................................. vi 1 2 3 4 5 6 7 Scope.................................................................................................................................................................................................................................. 1 Normative references....................................................................................................................................................................................... 1 Terms and definitions...................................................................................................................................................................................... 1 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.......................... 4 4.4.7 Verification activities....................................................................

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