AAMI-TIR13-2004.pdf
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1、Technical Information Report AAMI TIR13:1997 AAMI Association for the Advancement of Medical Instrumentation Principles of industrial moist heat sterilization Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111100
2、1, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TIR No. 131997 Principles of Industrial Moist Heat Sterilization Approved 24 February 1997 Abstract: This Technical Information Report provides tutorial information
3、 to industrial users of moist heat sterilization to supplement the requirements of ANSI/AAMI/ISO 11134, Sterilization of health care productsRequirements for validation and routine controlIndustrial moist heat sterilization (AAMI, 1993). The TIR also provides definitions of terms and a bibliography.
4、 Keywords: bioburden method, commissioning, cycle development, lethality, microbiological challenge, moist heat, overkill method, process control, steam sterilization, sterilization cycles, sterilization validation, validation Copyright Association for the Advancement of Medical Instrumentation Prov
5、ided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220
6、 Arlington, VA 22201-5762 1997 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 th
7、e prior 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 Associatio
8、n for 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.
9、Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-090-4 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001,
10、 User=Wing, Bernie Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TECHNICAL INFORMATION REPORT A Technical Information Report (TIR) is a publication of the AAMI Standards Board that has evolved during the development of a standard f
11、or 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 recommended p
12、ractice, 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, in the ca
13、se 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 standards
14、 and the TIRs are periodically reviewed, a standard must be acted uponeither 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 periodic
15、ally thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. In the event that the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying saf
16、ety or performance issue 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 wi
17、thdrawn 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. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license
18、with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Emplo
19、yees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- CONTENTS Committee representationvi Forewordvii 1Introduction and scope.1 2Definitions of terms1 3 Product and process considerations2 4Validation.9 5Routi
20、ne processing.16 Annexes AProduct equivalency.21 BSterilization cycles25 CStatistical determination of process equivalency.36 DReferences38 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Berni
21、e Not for Resale, 03/21/2007 02:51:18 MDTNo reproduction or networking permitted without license from IHS -,-,- vi 1997 Association for the Advancement of Medical Instrumentation COMMITTEE REPRESENTATION This Technical Information Report was developed by the AAMI Industrial Moist Heat Sterilization
22、Working Group under the auspices of the AAMI Sterilization Standards Committee. The Industrial Moist Heat Sterilization Working Group has the following members: Cochairs:James M. Gibson, Jr. Janet K. Schultz, MSN, RN Members:William C. Bradbury, PhD, Consultant, Sugarloaf, FL Virginia C. Chamberlain
23、, PhD, Quintiles Quality Regulatory Alliance, Inc. Douglas D. Davie, Sterilization Validation Services Sarah A. Deegan, Infusaid/Pfizer Richard J. DeRisio, Sorin Biomedical William F. FitzGerald, PE, Fitzgerald that is, the more resistant the challenge microorganism, the lower the population that ca
24、n be used. For example, the challenge characteristics of a 103 population having a D value of 2.0 min, or a 105 population with a D value of 1.2 min, are equivalent to those of a 106 population with a D value of 1.0 min. It is important to remember that the D values and z values of microbiological c
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