AAMI-TIR17-1997.pdf
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1、Technical Information Report AAMI TIR17:1997 AAMI Association for the Advancement of Medical Instrumentation Radiation sterilization Material qualification Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001,
2、User=Wing, Bernie Not for Resale, 03/21/2007 02:52:02 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TIR No. 171997 Radiation sterilizationMaterial qualification Approved 4 August 1997 Abstract:This AAMI Technical Information Report (TIR) details steps necessary to as
3、sess compatibility of health care product and packaging materials with radiation sterilization processes. Guidance is provided on selecting appropriate materials, choosing processing protocols that optimize product performance, and material testing as part of a qualification program. An extensive re
4、view of accelerated aging techniques is also included. Companion document to ANSI/AAMI/ISO 11137:1994. Keywords:sterilization, radiation, material qualification, accelerated aging, health care products, real time aging Copyright Association for the Advancement of Medical Instrumentation Provided by
5、IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:02 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlingt
6、on, VA 22201-5762 1998 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior
7、written permission of AAMI. All requests pertaining to this draft should 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 th
8、e 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 Kurt C. Larrick, Director, Technical Publishing, at AAMI, 1110 N. Glebe Ro
9、ad, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-107-2 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wi
10、ng, Bernie Not for Resale, 03/21/2007 02:52:02 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 th
11、at addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, there is value in releasing the information because of the immediate need for it by the industry and the professions. A TIR differs markedly from a standard or rec
12、ommended 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 Board and,
13、 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, although both
14、 standards and TIRs are periodically reviewed, a standard must be acted uponreaffirmed, 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 periodica
15、lly 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 performan
16、ce 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 Technical Information Report may be revised or withdrawn at any t
17、ime. Because it addresses 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. Comments on this technical information report are invited and should be sent to AAMI Standards Program, 3330 Washin
18、gton Boulevard, Suite 400, Arlington, VA 22201-4598. 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 02:52:02 MDTNo reproduction or networking permitted withou
19、t license from IHS -,-,- 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 02:52:02 MDTNo reproduction or networking permitted without license from IHS -,-,- CON
20、TENTS Page Committee representation.vii Forewordix Introduction.x 1Scope1 2Normative references.1 3Definitions, symbols, and abbreviations .2 3.1Aging definitions.2 3.2Statistical definitions.3 3.3Miscellaneous definitions 3 4Material selection4 4.1Functional compatibility4 4.2Biocompatibility9 5Mat
21、erial processing .10 5.1Polymer processing overview.10 5.2Impact of processing versus impact of radiation.10 6Material testing 12 6.1Definition of functional requirements.12 6.2Definition of challenge tests and acceptance criteria.13 7Accelerated aging programs.15 7.1Introduction15 7.2Characterizati
22、on of materials.16 7.3Defining an aging factor for related products.17 7.4Aging factor (AF) estimates 17 7.5Aging programs19 7.6Alternative aging methodologies26 7.7Biocompatibility considerations.26 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license w
23、ith AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:02 MDTNo reproduction or networking permitted without license from IHS -,-,- Annexes AMaterial radiation compatibility fundamentals27 BMaterial processing and product design guidelines29 CAccelerated aging
24、 theory31 DWorked example of fixed aging factor method32 EWorked example of iterative aging factor method.35 FBibliography42 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resal
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