AAMI-TIR20-2001.pdf
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1、Technical Information Report AAMI TIR20:2001 AAMI Association for the Advancement of Medical Instrumentation Parametric release for ethylene oxide sterilization Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111
2、001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information ReportAAMI TIR20:2001 Parametric release for ethylene oxide sterilization Approved 24 September 2001 by Association for the Advancement of M
3、edical Instrumentation Abstract:This AAMI technical information report (TIR) provides guidance to augment information and requirements for parametric release provided in ANSI/AAMI/ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide (EO) sterilization. This TIR is intende
4、d to assist those individuals using ANSI/AAMI/ISO 11135:1994 in understanding the steps necessary to develop and validate an ethylene oxide sterilization process that meets the standards requirements for parametric release. This TIR also provides guidance for choosing the appropriate actions where a
5、lternatives are given. The guidance in this TIR is limited to the sections of the standard that specifically address parametric release. Keywords:ethylene oxide, parametric release, sterilization, validation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under l
6、icense with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 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 Advan
7、cement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect 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 fo
8、r it. A TIR differs markedly from a standard or recommended 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 conse
9、nsus is supervised by the AAMI Standards Board and, in the case of American National Standards, 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 Stan
10、dards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, 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 abo
11、ut 5 years after the publication date (and 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
12、is more responsive to underlying safety or 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 in
13、formation report may be revised or withdrawn 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. All standards, recommended practices, technical information re
14、ports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authori
15、ties, in which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on 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
16、 the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2002 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any
17、part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation 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) w
18、ithout the prior written permission of the Association 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 AAMI at 1110
19、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 1570201676 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User
20、=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standards v Committee representationvii Introduction x 1Scope.1 2Cited references.1 3Definitions 1 4Equipment requirements3 4.1Precondition
21、ing4 4.2Sterilization chamber.4 4.3Aeration/degassing4 5Process analysis5 5.1Overview5 5.2Frequency of EO analysis .5 5.3EO analysis sampling location(s)5 5.4EO analysis accuracy5 6Process development.5 6.1Overview5 6.2Use of biological indicators to develop the sterilization process .7 6.3Methods o
22、f determining lethality7 6.3.1Methods overview.7 6.3.2Steps required by both methods.7 6.3.3Method A: Survivor curve constructionEnumeration of the BIs .8 6.3.4Method B: Fraction negative.8 6.3.5Sterilization cycle development process troubleshooting .9 6.4Sampling considerations for process develop
23、ment studies 10 6.5Performance of Method A or B in a pilot or a production chamber .10 6.5.1Four ways that Method A or B may be performed.10 6.5.2Establishing relationship between pilot chamber and production chamber 11 6.6Calculation of the sterilization cycle 12 6.7Documentation of the process dev
24、elopment.12 7Validation .12 7.1Commissioning (IQ/OQ)12 7.2Performance qualification (PQ)Microbiological12 7.3Load configuration.13 7.4Performance qualificationPhysical.13 7.5Revalidation.13 8Routine processing 14 9Product release14 9.1General14 9.2 Written procedures.14 9.3Electronic records and sig
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