AAMI-TIR32-2004.pdf
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1、 Technical Information Report AAMI TIR32:2004 Medical device software risk management Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:53:06 MDTNo reproducti
2、on or networking permitted without license from IHS -,-,- AAMI Technical Information Report AAMI TIR32:2004 Medical device software risk management Approved 23 December 2004 by Association for the Advancement of Medical Instrumentation Abstract: This AAMI technical information report provides inform
3、ation useful to performing effective software risk management, a significant part of the overall risk management process for medical devices containing software. It does this in the context of ANSI/AAMI/ISO 14971:2000, Medical devices Application of risk management to medical devices, and in the con
4、text of ANSI/AAMI SW68:2001, Medical device softwareSoftware life cycle processes. Keywords: hazard, risk, software Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/
5、2007 02:53:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 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
6、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 or recommended practice, and readers should und
7、erstand 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 Board and, in the case of American National Standar
8、ds, by 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, although both standards and TIRs are periodically r
9、eviewed, a standard 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 wh
10、ether 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 performance issues than a standard or recom
11、mended 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 addresses a rapidly evolving field or tech
12、nology, 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 voluntary, and their application is solely
13、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 its rules and regulations. Comments o
14、n 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 Arlington, VA 22201-4795 2005 by the
15、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 of the Association for the Advancement of Medical In
16、strumentation 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 the Advancement of Medical Instrumentation. Violator
17、s 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: (703) 525-4890; Fax: (703) 525-1067. Printed in the
18、United States of America ISBN 1570202338 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:53:06 MDTNo reproduction or networking permitted without license fr
19、om IHS -,-,- Contents Page Glossary of equivalent standards.v Committee representationvii Foreword.ix Introduction x 1 Scope1 1.1 Purpose1 1.2 Field of application .1 1.3 Usage.2 1.4 Organization.2 1.5 Limitations2 2 References2 3 Definitions.3 4 Perspective 1: Basic concepts of medical device softw
20、are risk management.6 4.1 Medical device risk management.6 4.1.1 Software risk cannot be managed effectively in isolation.6 4.1.2 Software input is an important part of device risk management.7 4.2 Software risk management.7 4.3 Risk control 11 4.3.1 Risk control through development assurance levels
21、14 4.3.2 Achieving development assurance level requirements 14 4.4 Integration of risk management in the software life cycle.15 4.4.1 Risk management is also essential for software maintenance.16 4.5 Common confusion regarding software risk management .16 5 Perspective 2: Software considerations in
22、medical device risk management17 5.1 Risk analysis17 5.1.1 Risk analysis procedure.18 5.1.2 Intended-use or intended-purpose identification19 5.1.3 Identification of known or foreseeable hazards20 5.1.4 Estimation of the risks for each hazard23 5.2 Risk evaluation.25 5.3 Risk control 27 5.3.1 Option
23、s analysis.27 5.3.2 Implementation of risk control measures .29 5.3.3 Residual risk evaluation.29 5.3.4 Other generated hazards.30 5.4 Risk management report30 5.5 Postproduction information.31 6 Perspective 3: Software risk management within a software life cycle32 6.1 Risk managementlife cycle int
24、egration.32 6.2 ANSI/AAMI SW68:2001 development process 35 6.2.1 Process implementation.35 6.2.2 Software requirements analysis.36 6.2.3 Software architectural design.38 6.2.4 Software detailed design41 6.2.5 Code and unit test42 6.2.6 Integration, system, and validation testing.46 6.2.7 Software re
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