ISO TR 24971-2013 Medical devices - Guidance on the application of ISO 14971《医疗器械 ISO 14971标准的应用导则》.pdf

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1、 ISO 2013 Medical devices Guidance on the application of ISO 14971 Dispositifs mdicaux Directives relatives lISO 14971 TECHNICAL REPORT ISO/TR 24971 First edition 2013-07-01 Reference number ISO/TR 24971:2013(E) ISO/TR 24971:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 201

2、3 All rights reserved. Unless otherwise specified, 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 request

3、ed from either ISO at the address below or ISOs member body in the country of the 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 Published in Switzerland ISO/TR 24971:2013(E) ISO 2013 All rights r

4、eserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 The role of international product safety and process standards in risk management 1 2.1 Overview 1 2.2 Use of international product safety standards in risk management 2 2.3 International process standards and ISO 14971 . 4 3 Develop

5、ing the policy for determining the criteria for risk acceptability .6 4 Production and post-production feedback loop . 6 4.1 Overview 6 4.2 Observation and transmission 7 4.3 Assessment . 9 4.4 Action 9 5 Differentiation of information for safety and disclosure of residual risk .10 5.1 Difference be

6、tween “information for safety” and “disclosure of residual risk” .10 5.2 Information for safety 10 5.3 Disclosure of residual risk 10 6 Evaluation of overall residual risk 11 6.1 Overview .11 6.2 Inputs and other considerations for overall residual risk evaluation 11 ISO/TR 24971:2013(E) Foreword IS

7、O (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 co

8、mmittee 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 electro

9、technical 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 the different approval criteria needed for the different types of ISO documents should be noted. This document was dra

10、fted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives 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 for identifying any or all such patent rights.

11、 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. www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not constitute an en

12、dorsement. ISO/TR 24971 was prepared jointly by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and Technical Committee IEC/SC 62A, Common aspects of electrical equipment used in medical practice. The draft was circulated for voting to the na

13、tional bodies of both ISO and IEC.iv ISO 2013 All rights reserved ISO/TR 24971:2013(E) Introduction Experience indicates that manufacturers have difficulty with practical implementation of some clauses of the risk management International Standard, ISO 14971:2007, Medical devices Application of risk

14、 management to medical devices. This Technical Report provides guidance to assist in the development, implementation and maintenance of risk management for medical devices that aim to meet the requirements of ISO 14971. It provides guidance for specific aspects of ISO 14971 for a wide variety of med

15、ical devices. These medical devices include active, non-active, implantable, and non-implantable medical devices and in vitro diagnostic medical devices. This Technical Report is not intended to be an overall guidance document on the implementation of ISO 14971 for organizations. It supplements the

16、guidance contained in the informative annexes of ISO 14971 related to the following areas. Guidance on the role of international product safety and process standards in risk management Guidance on developing the policy for determining the criteria for risk acceptability Guidance on how the productio

17、n and post-production feedback loop can work Guidance on the differentiation of information for safety as a risk control measure and disclosure of residual risk Guidance on the evaluation of overall residual risk This Technical Report provides some approaches that an organization can use to implemen

18、t and maintain some aspects of a risk management system that conforms to ISO 14971. Alternative approaches can be used if these satisfy the requirements of ISO 14971. When judging the applicability of the guidance in this Technical Report, one should consider the nature of the medical device(s) to w

19、hich it will apply, the risks associated with the use of these medical devices, and the applicable regulatory requirements. ISO 2013 All rights reserved v Medical devices Guidance on the application of ISO 14971 1 Scope This Technical Report provides guidance in addressing specific areas of ISO 1497

20、1 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: understand the role of international product safety and process standards in risk management; develop the policy for determining the criteria for risk acceptability; incorporate

21、production and post-production feedback loop into risk management; differentiate between “information for safety” and “disclosure of residual risk”; and evaluate overall residual risk. 2 The role of international product safety and process standards in risk manage- ment 2.1 Overview International pr

22、oduct safety and process standards play a significant role in risk management as described by ISO 14971. In principle, these standards are developed using a type of risk management that can include identifying hazards and hazardous situations, estimating risks, evaluating risks, and specifying risk

23、control measures. More information on a process for developing medical device standards using a type of risk management can be found in documents such as ISO/IEC Guide 51 and ISO/IEC Guide 63. International product safety and process standards are developed by experts in the field and represent the

24、generally accepted state of the art (see D.4 of ISO 14971:2007). These standards can have an important role in risk management. When performing risk management, the manufacturer first needs to consider the medical device being designed, its intended use and the hazards/hazardous situations related t

25、o it. Manufacturers can, if they choose, identify standard(s) that contain specific requirements that help manage the risks related to those hazards/hazardous situations. For medical devices that satisfy the requirements and compliance criteria of these standards, the residual risks related to those

26、 hazards/hazardous situations can be considered acceptable unless there is objective evidence to the contrary. Some potential sources of objective evidence to the contrary can include reports of adverse events, product recalls and complaints. The requirements of International Standards, such as engi

27、neering or analytical processes, specific output limits, warning statements, or design specifications, can be considered risk control measures established by the standards writers that are intended to address the risks of specific hazardous situations that have been identified and evaluated as needi

28、ng risk control. In many cases, the standards writers have taken on and completed elements of risk management and provided manufacturers with answers in the form of design requirements and test methods for establishing conformity. When performing risk management activities, manufacturers can take ad

29、vantage of the work of the standards writers and need not repeat the analyses leading to the requirements of the standard. International standards, therefore, provide valuable information on risk acceptability that has been validated during a worldwide evaluation process, including multiple rounds o

30、f review, comment, and voting. TECHNICAL REPORT ISO/TR 24971:2013(E) ISO 2013 All rights reserved 1 ISO/TR 24971:2013(E) 2.2 Use of international product safety standards in risk management An international product safety standard can establish requirements that, when implemented, result in acceptab

31、le risk for specific hazardous situations (e.g. safety limits). The manufacturer can apply these requirements in the following way when managing risk. a) Where an international product safety standard specifies technical requirements addressing particular hazards or hazardous situations, together wi

32、th specific acceptance criteria, compliance with those requirements is presumed to establish that the residual risks have been reduced to acceptable levels unless there is objective evidence to the contrary. For example, in IEC 60601-1, Medical electrical equipment Part 1: General requirements for b

33、asic safety and essential performance, leakage current must be controlled to achieve an acceptable level of risk. IEC 60601-1 provides leakage current limits that are considered to result in an acceptable level of risk when measured under the conditions stated in 8.7 of IEC 60601-1:2005. For this ex

34、ample, further risk management would not be necessary. The following steps need to be taken in this case. 1) Implement 4.2 and 4.3 of ISO 14971:2007 to identify characteristics related to safety and identify hazards and hazardous situations associated with the device as completely as possible. 2) Id

35、entify those hazards and hazardous situations relevant to the particular medical device that are exactly covered by the international product safety standard. 3) For those identified hazards and hazardous situations exactly covered by the international product safety standard, the manufacturer may c

36、hoose not to estimate (4.4 of ISO 14971:2007) or evaluate (Clause 5 of ISO 14971:2007) the risks so identified but rather rely on the requirements contained in the international standard to demonstrate the completion of risk estimation and risk evaluation. 4) To the extent possible, the manufacturer

37、 should identify the design specifications that satisfy the requirements in the standard and serve as risk control measures (6.2 of ISO 14971:2007). NOTE For some international product safety standards, the possibility of identifying all the specific risk control measures is limited. One example is

38、electromagnetic compatibility testing in IEC 606011-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests, for complex medical devices. 5) Verification of the implementation

39、of the risk control measures for these hazardous situations is obtained from the design documents. Verification of the effectiveness of the risk control measures is obtained from the tests and test results demonstrating that the device meets the relevant requirements of the international product saf

40、ety standard. 6) If the relevant requirements are met, the associated residual risk is considered acceptable. b) Where an international product safety standard does not completely specify technical requirements and associated tests and test acceptance criteria, the situation is more complex. In some

41、 cases, the standard directs the manufacturer to perform specific tests related to known hazards or hazardous situations but does not provide specific test acceptance criteria (e.g. IEC 60601-2-16, Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential perform

42、ance of haemodialysis, haemodiafiltration and haemofiltration equipment). In some other cases, the standard can simply direct the manufacturer to investigate specific hazards or hazardous situations in their risk analysis (e.g. 10.2 of IEC 60601-1:2005). The range of alternatives is too large to pro

43、vide specific guidance on how to use such standards in the risk management process. Manufacturers are encouraged, however, to use the content of such standards in their risk management of the particular medical device. c) For hazards or hazardous situations that are identified for the particular med

44、ical device but are not specifically addressed in any standard, the manufacturer needs to address those hazards or hazardous situations in the risk management process. The manufacturer is required to estimate and evaluate the risks and, if necessary, control these risks (see 4.4 and Clauses 5 and 6

45、of ISO 14971:2007).2 ISO 2013 All rights reserved ISO/TR 24971:2013(E) See Figure 1 for a flowchart and an example outlining the use of international product safety standards. h l pc ? w ?Chbw b lpc pc qmpv pccccpc cD qm llmch hgclg ? Nm vlk5 hg pcchchv hqmh 6 Vhcv 6bpmg ccghhp, llk c ccpbl6Y Y pmclvc bmmh;p pp,qpmvblcpll Yhpcqm Thqpmhllvblcwhplc ppmlplclgl mhhlpl,pccccpcc hqpmvblc,cmpl whhqmYEC66-5, bcl Y,qpmpbl,cbpwh hpccmmpRkmvlpmplm kclmhkmgml Tpmqpmplcplcl glmhhlpl Rlm