AAMI-TIR15-1997.pdf
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1、Technical Information Report AAMI TIR15:1997 AAMI Association for the Advancement of Medical Instrumentation Ethylene oxide sterilization equipment, process considerations, and pertinent calculations Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license w
2、ith AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:20 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TIR No.151997 Ethylene Oxide Sterilization Equipment, Process Considerations, and Pertinent Calculations Approved 4 August
3、1997 Abstract:This AAMI Technical Information Report (TIR) provides additional guidance to ANSI/AAMI/ISO 111351994, Medical devicesValidation and routine control of ethylene oxide sterilization. The topics covered under this TIR are sterilization equipment, considerations for preconditioning, calcul
4、ations for relative humidity, calculations of ethylene oxide concentration, and flammability. Keywords:ethylene oxide concentration, flammability, preconditioning, relative humidity, sterilization equipment, calculations Copyright Association for the Advancement of Medical Instrumentation Provided b
5、y IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:20 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlin
6、gton, 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 prio
7、r 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
8、the 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
9、Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-102-1 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=
10、Wing, Bernie Not for Resale, 03/21/2007 02:51:20 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
11、that 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 r
12、ecommended 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 an
13、d, 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 bo
14、th standards and TIRs are periodically reviewed, a standard must be acted upon either reaffirmed, 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
15、 periodically 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
16、 performance 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 withdraw
17、n at any time. 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, 3
18、330 Washington 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 02:51:20 MDTNo reproduction or networking permit
19、ted without 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 02:51:20 MDTNo reproduction or networking permitted without license from IHS
20、 -,-,- CONTENTS Committee representationvi Acknowledgementsviii Introduction1 1 Scope.1 2 Definitions1 3 EO sterilization equipment.2 4 Determination of minimum product temperature prior to preconditioning. 8 5 Calculation of percent relative humidity10 6 Calculation of EO concentration13 7 Calculat
21、ions for use of flammability curve18 Annex A Bibliography21 Tables 1 List of constants and molecular weights of some common EO/diluent combinations14 2 Gas constants (R) .16 3 Flamability review, partial pressures, and volume percentage 20 Copyright Association for the Advancement of Medical Instrum
22、entation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:20 MDTNo reproduction or networking permitted without license from IHS -,-,- vi 1998 Association for the Advancement of Medical Instrumentation COMMITTEE REPRESENTAT
23、ION The AAMI Industrial Ethylene Oxide Sterilization Working Group developed this technical information report under the auspices of the AAMI Sterilization Standards Committee. The AAMI Sterilization Standards Committee has the following members: Cochairs:Virginia C. Chamberlain, PhD William E. Youn
24、g Members:Carl W. Bruch, PhD, Consultant, Hudson, WI Virginia C. Chamberlain, PhD, Hendersonville, NC Neal E. Danielson, Ds Enterprise, Wichita, KS Judith C. Dowler, Medical Devices Bureau, Health Canada, Ottawa, ON Frank B. Engley, Jr., PhD, University of Missouri, Columbia, MO Victoria Hitchins, P
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