AAMI-TIR62296-2003 5.28.pdf
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1、 Technical Information Report ANSI/AAMI/IEC TIR62296:2003 AAMI Association for the Advancement of Medical Instrumentation Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Copyright Association for the Advancement of Medical Instrume
2、ntation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:54:06 MDTNo reproduction or networking permitted without license from IHS -,-,- An ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR62296:2003 Considerations of u
3、naddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements Approved 8 October 2003 by Association for the Advancement of Medical Instrumentation Registered 23 November 2003 by American National Standards Institute Abstract: This AAMI Technical Information Repor
4、t contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. This report is primarily intended to be used by manufacturers of medical electrical equipment; test houses and others r
5、esponsible for assessment of compliance with IEC 60601-1; and those developing subsequent editions of IEC 60601-1. The object of this report is to make the recommendations/interpretations developed by the experts in IEC/SC 62A/WG 14 available to those interested in the application of the Second Edit
6、ion of IEC 60601-1. Keywords: electromedical equipment, interpretations, safety, testing 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 02:54:06 MDTNo reprodu
7、ction or networking permitted without license from IHS -,-,- Published by Association for the Advancement of Medical Instrumentation 1110 N Glebe Road, Suite 220 Arlington, VA 22201-4795 2003 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is su
8、bject to copyright claims of IEC, 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 draft should be submitted to AAMI. It is illegal under f
9、ederal 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, including civil and criminal penalties, and d
10、amages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202052 Copyright Association for t
11、he Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:54:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 2003 Association for the Advancement of Medical Instrum
12、entation ANSI/AAMI/IEC TIR62296:2003 iii 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 technology. Although the material pr
13、esented 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 understand the differences between these documents
14、. 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 American National Standards Institut
15、e. 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 standard must be acted onreaffirmed,
16、 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 document is still usefulthat is, to c
17、heck 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 practice, or because achieving consensus
18、 is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI technical information report may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are ca
19、utioned 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 within the discretion
20、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 technical infor
21、mation 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 ANSI Techni
22、cal 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 ANSI Technical Reports. This document is not an American National Standard and the material containe
23、d herein is not normative in nature. Comments on the content of this document should be sent to AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111100
24、1, User=Wing, Bernie Not for Resale, 03/21/2007 02:54:06 MDTNo reproduction or networking permitted without license from IHS -,-,- 2003 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR62296:2003 iv Contents Page Glossary of equivalent standards vi Committee representation
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