ANSI TIR80002-1-2009 Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software.pdf

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1、ANSI/AAMI/IEC TIR80002-1:2009 Association for the Advancementof Medical InstrumentationMedical device software - Part 1: Guidance on the application of ISO 14971 to medical device softwareAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidan

2、ce on the application of ISO 14971 to medical device software Approved 3 September 2009 by Association for the Advancement of Medical Instrumentation Registered 26 October 2009 by American National Standards Institute Abstract: Provides information useful for the performance of effective software ri

3、sk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices - Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software - Software life

4、cycle processes. Keywords: risk management, software life cycle, medical device software Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advancement of Medical Instrumentation

5、All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document shoul

6、d be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action,

7、including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (

8、703) 525-1067. Printed in the United States of America ISBN 1-57020-371-7 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical tec

9、hnology. Although the material presented in a TIR might need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the

10、differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the A

11、merican National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a s

12、tandard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the do

13、cument is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended pract

14、ice or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, reade

15、rs are cautioned to ensure that they have also considered information that might be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the

16、discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on this tech

17、nical information report are invited and should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this

18、ANSI Technical Report has been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the m

19、aterial contained herein is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Contents Page Glossary of equivalent standards vi Committee representationviii Background of AAMI

20、 adoption of IEC TIR8002-1:2009. x FOREWORD xi INTRODUCTION xiii 1 General 1 1.1 Scope . 1 1.2 Normative references 2 2 Terms and definitions . 2 3 General requirements for RISK MANAGEMENT 3 3.1 RISK MANAGEMENT PROCESS 3 3.2 Management responsibilities . 7 3.3 Qualification of personnel 8 3.4 RISK M

21、ANAGEMENT plan .10 3.5 RISK MANAGEMENT FILE 12 4 RISK ANALYSIS14 4.1 RISK ANALYSIS PROCESS.14 4.2 INTENDED USE and identification of characteristics related to the SAFETY of the MEDICAL DEVICE.15 4.3 Identification of HAZARDS.17 4.4 Estimation of the RISK(S) for each HAZARDOUS SITUATION 19 5 RISK EV

22、ALUATION22 6 RISK CONTROL23 6.1 RISK reduction23 6.2 RISK CONTROL option analysis .23 6.3 Implementation of RISK CONTROL measure(s) .33 6.4 RESIDUAL RISK EVALUATION 34 6.5 RISK/benefit analysis 34 6.6 RISKS arising from RISK CONTROL measures .35 6.7 Completeness of RISK CONTROL.35 7 Evaluation of ov

23、erall residual risk acceptability 36 8 Risk management report .37 9 Production and POST-PRODUCTION information 38 Annex A (informative) Discussion of definitions 40 Annex B (informative) Examples of software causes42 Annex C (informative) Potential software-related pitfalls 52 Annex D (informative)

24、Life-cycle/risk management grid57 Annex E (informative) SAFETY cases .60 Bibliography 61 Index.62 Index of defined terms .63 Figure 1 Pictorial representation of the relationship of HAZARD, sequence of events, HAZARDOUS SITUATION and HARM from ISO 14971:2007 Annex E 21 Figure 2 FTA showing RISK CONT

25、ROL measure which prevents incorrect software outputs from causing HARM 25 Figure A.1 Relationship between sequence of events, HARM and HAZARD .40 Table 1 Requirements for documentation to be included in the RISK MANAGEMENT FILE in addition to ISO 14971:2007 requirements 13 Table A.1 Relationship be

26、tween HAZARDS, foreseeable sequences of events, HAZARDOUS SITUATIONS and the HARM that can occur.41 Table B.1 Examples of causes by software function area.42 Table B.2 Examples of software causes that can introduce side-effects .48 Table B.3 Methods to facilitate assurance that RISK CONTROL methods

27、are likely to perform as intended.51 Table C.1 Potential software-related pitfalls to avoid .52 Table D.1 LIFE-CYCLE/RISK MANAGEMENT grid57 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For eac

28、h International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be und

29、er consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:20

30、09 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-

31、24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC

32、 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical IEC/TR 80002-1:2009 ANSI/IEC/TR 80002-1:2009 Identical I

33、SO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2009 ANSI/

34、AAMI/ISO 10993-1:2009 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 Identical ISO 10993-5:2009 ANSI/AAMI/ISO 10993-5:2

35、009 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technic

36、al variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 1099

37、3-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2009 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002/(R)2008 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2

38、006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical vi 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80002-1

39、:2009 International designation U.S. designation Equivalency ISO 11137-2:2006 (2006-08-01 corrected version)ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Id

40、entical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-3:2007 ANS

41、I/AAMI/ISO 11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identic

42、al ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical ISO 13408-2:2003 ANSI/AAMI/ISO 13408-2:2003 Identical ISO 13408-3:2006 ANSI/AAMI/ISO 13408-3:2006 Identical ISO 13408-4:2005 ANSI/AAMI/ISO 13408-4:2005 Identical ISO 13408-5:2006 ANSI/AAMI/

43、ISO 13408-5:2006 Identical ISO 13408-6:2006 ANSI/AAMI/ISO 13408-6:2006 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003/(R)2008 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003/(R)2008 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998/(R)20

44、08 Identical ISO 14161:2009 ANSI/AAMI/ISO 14161:2009 Identical ISO 14708-3:2008 ANSI/AAMI/ISO 14708-3:2008 Identical ISO 14708-4:2008 ANSI/AAMI/ISO 14708-4:2008 Identical ISO 14937:2009 ANSI/AAMI/ISO 14937:2009 Identical ISO/TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2007 ANSI/AAM

45、I/ISO 14971:2007 Identical ISO 15223-1:2007 and A1:2008 ANSI/AAMI/ISO 15223-1:2007 and A1:2008 Identical ISO 15225:2000 and A1:2004 ANSI/AAMI/ISO 15225:2000/(R)2006 and A1:2004/(R)2006 Identical ISO 15674:2009 ANSI/AAMI/ISO 15674:2009 Identical ISO 15675:2009 ANSI/AAMI/ISO 15675:2009 Identical ISO 1

46、5882:2008 ANSI/AAMI/ISO 15882:2008 Identical ISO 15883-1:2006 ANSI/AAMI ST15883-1:2009 Major technical variations ISO/TR 16142:2006 ANSI/AAMI/ISO TIR16142:2005 Identical ISO 17664:2004 ANSI/AAMI ST81:2004 Major technical variations ISO 17665-1:2006 ANSI/AAMI/ISO 17665-1:2006 Identical (with inclusio

47、ns) ISO/TS 17665-2:2009 ANSI/AAMI/ISO TIR17665-2:2009 Identical ISO 18472:2006 ANSI/AAMI/ISO 18472:2006 Identical ISO/TS 19218:2005 ANSI/AAMI/ISO 19218:2005 Identical ISO 22442-1:2007 ANSI/AAMI/ISO 22442-1:2007 Identical ISO 22442-2:2007 ANSI/AAMI/ISO 22442-2:2007 Identical ISO 22442-3:2007 ANSI/AAM

48、I/ISO 22442-3:2007 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003/(R)2009 and A1:2005/(R)2009 Identical ISO 25539-2:2008 ANSI/AAMI/ISO 25539-2:2008 Identical ISO 81060-1:2007 ANSI/AAMI/ISO 81060-1:2007 Identical ISO 81060-2:2009 ANSI/AAMI/ISO 81060-2:2009 Identical 2009 Associatio

49、n for the Advancement of Medical Instrumentation ANSI/AAMI/IEC 80002-1:2009 vii Committee representation Association for the Advancement of Medical Instrumentation Medical Device Software Committee The adoption of IEC Technical Report 80002-1:2009 as an AAMI Technical Information Report and ANSI Technical Report was initiated by the AAMI Medical Device Software Committee and the AAMI Quality Management Committee. Committee approval of the technical report does not necessarily imply that all committee members voted for its approval. At the time this documen