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Iso 14971:2019(E) This is a preview - click here to buy the full publication INTERNATIONAL ISO STANDARD 14971 Third edition 2019-12 Medical devices — Application of risk management to medical devices Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux Reference number ISO 14971:2019(E) © ISO 2019 This is a preview - click here to buy the full publication ISO 14971:2019(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2019 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:Website: +41 22www.iso.org 749 09 47 Email: [email protected] iiPublished in Switzerland © ISO 2019 – All rights reserved This is a preview - click here to buy the full publication ISO 14971:2019(E) Contents Page Foreword ........................................................................................................................................................................................................................................iv Introduction ................................................................................................................................................................................................................................vi 1 Scope ................................................................................................................................................................................................................................. 1 2 Normative references ...................................................................................................................................................................................... 1 3 Terms and definitions ..................................................................................................................................................................................... 1 4 General requirements for risk management system ...................................................................................................... 7 4.1 Risk management process ........................................................................................................................................................ 7 ..................................................................................................................................................... 4.3 Competence of personnel .............................................................................................................................................................. 9 4.24.4 ManagementRisk management responsibilities .................................................................................................................................................................. 89 4.5 Risk management file ................................................................................................................................................................10 plan 5 Risk analysis ..........................................................................................................................................................................................................10 5.1 Risk analysis process ..................................................................................................................................................................10 5.2 Intended use reasonably foreseeable misuse ..........................................................................................10 safety ................................................................................................11 andhazards hazardous situations ......................................................................................11 5.35.5 IdentificationRisk estimation of charact .................................................................................................................................................................................eristics related to 11 5.4 Identification of and 6 Risk evaluation ....................................................................................................................................................................................................12 7 Risk control .............................................................................................................................................................................................................12 7.1 Risk control ....................................................................................................................................................12 risk control ..................................................................................................................13 7.3 Residual risk option analysis .............................................................................................................................................................13 7.27.4 ImplementationBenefit-risk of ....................................................................................................................................................................... measures 14 7.5 Risks evaluationrisk control ...................................................................................................................14 7.6 Completeness analysis of risk control ................................................................................................................................................14 arising from measures 8 Evaluation of overall residual risk ..................................................................................................................................................14 9 Risk management review ..........................................................................................................................................................................15 10 Production and post-production activities..............................................................................................................................15 ........................................................................................................................................................................................................15 ...................................................................................................................................................................15 10.1 General ..........................................................................................................................................................................16 10.210.4 InformationActions ......................................................................................................................................................................................................... collection 16 10.3 Information review Annex A Rationale for requirements ...........................................................................................................................17 Annex B Risk management process for medical devices ...........................................................................26 (informative) Annex C Fundamental risk concepts ............................................................................................................................30 (informative) Bibliography .............................................................................................................................................................................................................................36 (informative) © ISO 2019 – All rights reserved iii This is a preview - click here to buy the full publication ISO 14971:2019(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular,www .isothe .org/different directives approval). criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial 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 of patent rights. ISO shall not be held responsible forwww identifying .iso .org/ any or all). such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see
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