AAMI-TIR34-2007.pdf
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1、AAMI TIR34:2007 Association for the Advancement of Medical Instrumentation Water for the reprocessing of medical devices Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/
2、30/2008 01:58:38 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 Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:58:38 MDTNo reprodu
3、ction or networking permitted without license from IHS -,-,- AAMI Technical Information Report AAMI TIR34:2007 Water for the reprocessing of medical devices Approved 15 October 2007 by Association for the Advancement of Medical Instrumentation Abstract: This technical information report (TIR) covers
4、 the selection and maintenance of effective water quality suitable for reprocessing medical devices. It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality
5、 control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations. Keywords: carbon filters, deionization, disinfection, distillation, pasteurization, reverse osmosis, sediment filters, sterilization, ultrafiltration, water filtration,
6、 water quality, water softening, water treatment Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:58:38 MDTNo reproduction or networking permitted without lice
7、nse 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 that addresses a particular aspect of medical technology. Although the material presented in a TIR may n
8、eed 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. Standards and recomm
9、ended 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 Institute. A TIR is not subjec
10、t 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, revised, or withdrawn
11、and 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 periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is
12、 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 is extremely difficult or u
13、nlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR 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 info
14、rmation 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 and professional judgment of the user of the document
15、. 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 information report are invited and should be sent to AAMI,
16、 Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Published by Association for the Advancement of Medical Instrumentation 1110 N Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2008 by the Association for the Advancement of Medical Instrumentation All
17、Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any 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 unde
18、r 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 the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, an
19、d damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI at 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 1-57020-302-4 Copyright Associati
20、on for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:58:38 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standardsv C
21、ommittee representation.vii Acknowledgments.ix Foreword.ix Introduction .xi 1 Scope.1 1.1 General.1 1.2 Inclusions1 1.3 Exclusions.1 2 Definitions and abbreviations.1 3 The importance of water quality and effective water treatment 6 3.1 Introduction.6 3.2 Major impacts of adverse water quality on me
22、dical device reprocessing6 3.2.1 General considerations.6 3.2.2 Microbial level in water .7 3.2.3 Inorganic and organic components of water.7 3.2.4 Water temperature9 3.3 Treatment of water9 3.3.1 General considerations.9 3.3.2 Pretreatment.10 3.3.3 Principal water treatment processes.10 3.3.4 Distr
23、ibution systems11 3.4 Categories of medical devices11 3.5 Stages of medical device reprocessing in which water quality is a consideration .12 4 Categories of water quality for medical device reprocessing13 4.1 Introduction.13 4.2 Four categories of water quality13 5 Selection of water quality .17 5.
24、1 Introduction.17 5.2 Cleaning17 5.2.1 Manual cleaning .17 5.2.2 Automated cleaning by medical washers and medical washerdisinfectors.18 5.2.3 Automated cleaning by ultrasonic cleaners 20 5.3 Disinfection and sterilization20 5.3.1 General considerations.20 5.3.2 Medical devices that receive steam st
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