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1、AAMI TIR36:2007 Association for the Advancement of Medical Instrumentation Validation of software for regulated processes AAMI Technical Information Report AAMI TIR36:2007 Validation of software for regulated processes Developed by Association for the Advancement of Medical Instrumentation Approved
2、13 December 2007 by Association for the Advancement of Medical Instrumentation Abstract: Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality syst
3、em as defined by the Quality System Regulation (21 CFR 820). In addition, it applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements (21 CFR 11). This TIR can also be broadly applied wherever soft
4、ware automates processes regulated by the FDA. This TIR applies to software used in the production of a device and to software used in implementation of the device manufacturers quality system. It does not apply to software used as a component, part, or accessory of a medical device or software that
5、 is itself a medical device. Keywords: medical device software, medical electrical equipment, electromedical equipment, risk management AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Sta
6、ndards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may 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
7、 or recommended practice, and readers should understand the 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 Boa
8、rd and, in the case of American National Standards, the American 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, althou
9、gh both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or withdrawnand the action formally approved usually every 5 years but at least every 10 years. For a TIR, AAMI consults with a technical committee about 5 years after the publication date (and peri
10、odically thereafter) for guidance on whether the document 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 perf
11、ormance issues than a standard or recommended practice 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 addr
12、esses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are volun
13、tary, and their application is solely within the 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
14、 its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220
15、 Arlington, VA 22201-4795 www.aami.org 2008 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission o
16、f the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 t
17、he Advancement of Medical Instrumentation. Violators risk legal action, 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, contact AAMI at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (
18、703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-306-7 Contents Page Glossary of equivalent standards.v 4 Committee representationvi Forewordviii Introduction .x 1 General . 1 1.1 Purpose and intent. 1 1.2 Scope. 1 1.3 Document organization 2 2 Regulatory cont
19、ext 2 2.1 Context of 21 CFR 820.70(i), Automated processes. 2 2.2 Context of the Quality System Regulation (QSR) 21 CFR 820 3 2.3 Context of 21 CFR 11 3 2.4 Context of the General Principles of Software Validation 4 3 Software validation discussion 4 3.1 Definition 4 3.2 Confidence-building activiti
20、es: The tools in the toolbox. 4 3.3 Critical thinking 5 4 Software validation and critical thinking 5 4.1 Overview 5 4.2 In scope?. 9 4.3 Develop phase. 10 4.4 Maintain phase 19 4.5 Retire phase 20 5 Documentation 21 6 Prerequisite processes . 21 Annexes A The toolbox. 23 B Risk management. 38 C Exa
21、mples 46 Example 1: PLC for manufacturing equipment. 47 Example 2: Automated welding system 50 Example 3: Automated welding process control system 52 Example 4: C/C+ language compiler 58 Example 5: Automated Software Test System. 62 Example 6: A simple spreadsheet 66 Example 7: A (not so) simple spr
22、eadsheet. 69 Example 8: Parametric sterilizer. 73 Example 9: Nonconforming material reporting systemTotal system upgrade 77 Example 10: Software for scheduling nonconforming material report review board meetings 81 Example 11: Approved vendor list system 83 Example 12: Calibration management softwar
23、e. 87 Example 13: Automated vision system. 91 Example 14: Pick and place system. 93 D Definitions. 96 E Bibliography 99 iv 2008 Association for the Advancement of Medical Instrumentation AAMI TIR36:2007 Glossary of equivalent standards International Standards adopted in the United States may include
24、 normative references to other International Standards. For each 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.
25、Other normatively referenced International Standards may be under 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
26、-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996
27、ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations I
28、EC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI
29、/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993
30、-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002 and Amendment 1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AA
31、MI/ISO 10993-6:2007 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 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 ANSI/AAMI BE78:2002/A1:2006 Minor technical variations Identical ISO 10993-11:2006 ANSI
32、/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 10993-15:2000/(R)2006 Identical ISO 10993-16:1997
33、ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical 2008 Association for the Advancement of Medical Instrumentation AAMI TIR36:2007 v International designation U.S. designation Equivalency ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variati
34、ons ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical ISO 11137-1:2006 ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected version) ANSI/AAMI/ISO 11
35、137-2:2006 Identical ISO 11137-3:2006 ANSI/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 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 1
36、1138-5: 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 ANSI/AAMI/ISO 11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 1114
37、0-5:2007 Identical ISO 11607-1:2006 ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006 ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO 13485:
38、2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998 Identical ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical IS
39、O/TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2007 ANSI/AAMI/ISO 14971:2007 Identical ISO 15223-1:2007 ANSI/AAMI/ISO 15223-1:2007 Identical ISO 15225:2000 and A1:2004 ANSI/AAMI/ISO 15225:2000/(R)2006 and A1:2004/(R)2006 Identical ISO 15674:2001 ANSI/AAMI/ISO 15674:2001 Identical IS
40、O 15675:2001 ANSI/AAMI/ISO 15675:2001 Identical ISO 15882:2003 ANSI/AAMI/ISO 15882:2003 Identical 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 ISO 18472:2006 ANSI/AAMI/ISO 1
41、8472:2006 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/AAMI/ISO 22442-3:2007 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003 and A1:20
42、05 Identical vi 2008 Association for the Advancement of Medical Instrumentation AAMI TIR36:2007 Committee representation Association for the Advancement of Medical Instrumentation AAMI Medical Device Software Committee This technical information report (TIR) was developed by the AAMI Medical Device
43、Software Committee. Committee approval of the TIR does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Medical Device Software Committee had the following members: Chairs: Sherman Eagles John F. Murray Jr. Members: Randy Arms
44、trong, Cyberonics Inc. David R. Christie, Spacelabs Medical Inc. Theresa Dennis, Sterigenics International Andrew Dunham, Baxter Healthcare Corp. Sherman Eagles, Medtronic Inc. Christine Flahive, Belle Mead, NJ Larry Fry, Draeger Medical Nancy George, Towson, MD Ron Gerner, Abbott Laboratories Steve
45、n Gitelis, GB Lumina Inc. Lori Haller, Steris Corp. James Hempel, Covidien Sam Jarrell, CerTech LLC Jeremy Jensen, Guidant/Boston Scientific Corp. David R. Jones, Philips Medical Systems Martin J. King, Hospira Worldwide Inc. Alan Kusinitz, SoftwareCPR Bernie Liebler, Advanced Medical Technology Ass
46、ociation (AdvaMed) Don Lin, Irvine, CA Steve Mallory, Welch Allyn Inc. Mark Maritch, Datascope Corp. Don McAndrews, Respironics Inc. Mary Beth McDonald, St. Jude Medical Dennis Mertz, Becton Dickinson John F. Murray Jr., U.S. Food and Drug Administration Raj Raghavendran, Johnson therefore, it is es
47、sential that you receive an appropriate return on this investment. So, why do some people feel that they are not getting as much value out of their software validation activities as they should? Why do some people feel as if they have to do too much to achieve compliance with this requirement? Why d
48、o some people feel as if their software validation activities are not aligned with their business goals or interest? Why do some people feel as if their internal software validation activities are redundant when they use high-quality off-the- shelf (OTS) software? Why are some people doing too littl
49、e or doing nothing at all? Why is there uncertainty about which software requires validation and which software does not? This technical information report (TIR) is intended to help you understand the issues behind these questions and to give you suggestions on how to develop a more value-added approach to software validation. It is important to note that a medical device regulation requiring software validation does exist. The regulation section, 21 CFR 820.70(i), Automated processes, is written in broad terms so that it can apply to all medical device manufactur
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