CAN CSA-ISO 14971-2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition).pdf

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1、 Reference numberISO 14971:2007(E)ISO 2007Medical devices Application of risk management to medical devices Dispositifs mdicaux Application de la gestion des risques aux dispositifs mdicaux National Standard of CanadaCAN/CSA-ISO 14971:07(ISO 14971:2007)International Standard ISO 14971:2007 (second e

2、dition, 2007-03-01) has been adopted withoutmodification (IDT) as CSA Standard CAN/CSA-ISO 14971:07, which has been approved as a NationalStandard of Canada by the Standards Council of Canada.ISBN 978-1-55436-513-5 May 2007 International Organization for Standardization (ISO), 2007. All rights reser

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34、Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-ISO 14971:07Medical devices Application of risk management to medical devicesRegistered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternatio

35、nal Organization for StandardizationCAN/CSA-ISO 14971:07Medical devices Application of riskmanagement to medical devicesMay 2007 Canadian Standards Association CSA/3CAN/CSA-ISO 14971:07Medical devices Application of risk management to medical devicesCSA PrefaceThis is the second edition of CAN/CSA-I

36、SO 14971, Medical devices Application of risk management to medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14971 (second edition, 2007-03-01). This Standard supersedes the previous edition published i

37、n 2001 as CAN/CSA-ISO 14971 (adopted ISO 14971:2000) and CSA Amendment 1:2003 to CAN/CSA-ISO 14971:01 (adopted ISO Amendment 1:2003).This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Quality Management and General Aspects for Medical Devices, under the jurisdiction o

38、f the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.May 2007 Canadian Standards Association 2007All rights reserved. No part of thi

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41、0-463-6727 or 416-747-4044.Reference numberISO 14971:2007(E)ISO 2007INTERNATIONAL STANDARD ISO14971Second edition2007-03-01Medical devices Application of risk management to medical devices Dispositifs mdicaux Application de la gestion des risques aux dispositifs mdicaux ISO 14971:2007(E) PDF disclai

42、mer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties acc

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44、file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2007 All righ

45、ts reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the

46、 requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org ii ISO 2007 All rights reservedCAN/CSA-ISO 14971:07ISO 14971:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scop

47、e . 1 2 Terms and definitions. 1 3 General requirements for risk management 5 3.1 Risk management process 5 3.2 Management responsibilities 7 3.3 Qualification of personnel . 7 3.4 Risk management plan. 7 3.5 Risk management file. 8 4 Risk analysis . 8 4.1 Risk analysis process 8 4.2 Intended use an

48、d identification of characteristics related to the safety of the medical device. 9 4.3 Identification of hazards 9 4.4 Estimation of the risk(s) for each hazardous situation. 9 5 Risk evaluation 10 6 Risk control . 11 6.1 Risk reduction . 11 6.2 Risk control option analysis 11 6.3 Implementation of

49、risk control measure(s) 11 6.4 Residual risk evaluation. 12 6.5 Risk/benefit analysis 12 6.6 Risks arising from risk control measures12 6.7 Completeness of risk control 12 7 Evaluation of overall residual risk acceptability . 13 8 Risk management report 13 9 Production and post-production information 13 Annex A (informative) Rationale for requirements . 15 Annex B (informative) Overview of the risk management process for medical devices 23 Annex C (informative) Questions that can be used to identify medical device characteristics t