AAMI-TIR11-2005.pdf
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1、 Selection and use of protective apparel and surgical drapes in health care facilities AAMI TIR11:2005 Technical Information Report Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for
2、Resale, 02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information Report AAMI TIR11:2005 Selection and use of protective apparel and surgical drapes in health care facilities Approved 17 October 2005 Association for the Advancement of Me
3、dical Instrumentation Abstract: This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection,
4、levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided. Keywords: barrier properties, drapes, isolation gowns, protective apparel, surgical attire (Revision of AAMI TIR11:1994) Copyright Association for the Advancement
5、 of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from IHS -,-,- AAMI Technical Information Report A technical information report (TIR)
6、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 need further evaluation by experts, releasing the information is valuable because the indus
7、try 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 recommended practices are subject to a formal process of committee approval, public review, and
8、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 subject to the same formal approval process as a standard. However, a TIR is approved for distri
9、bution 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 on reaffirmed, revised, or withdrawnand the action formally approved usually every 5 years but at least every 10 years. For a
10、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 relevant or of historical value. If the information is not useful, the TIR is removed fro
11、m 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 unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technic
12、al issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field of technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. All standards, recommended practices,
13、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. Occasionally, voluntary technical documents are adopted by government regulatory agencie
14、s 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, Technical Programs, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Published by
15、 Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2005 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise
16、, 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 under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally
17、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, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, conta
18、ct 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 1570202419 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/
19、1111111001, User=Japan, IHS Not for Resale, 02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from IHS -,-,- Contents Committee representationvii Acknowledgments.viii Foreword.ix 1 Introduction and scope.1 2 Definitions of terms 1 3 Types of surgical protective materials
20、3 3.1 Introduction.3 3.2 Multiple-use materials.3 3.2.1 General considerations.3 3.2.2 Historical materials .4 3.2.3 Current materials 4 3.3 Single-use materials .4 3.4 Reinforcement of multiple-use and single-use products5 4 Safety and performance characteristics.5 4.1 Introduction.5 4.2 Barrier ef
21、fectiveness.5 4.2.1 Resistance to liquid and microbial penetration5 4.2.2 Resistance to penetration by airborne, aerosol-borne, or dry particles .9 4.3 Abrasion resistance 9 4.4 Strength9 4.4.1 General considerations.9 4.4.2 Breaking strength10 4.4.3 Tear strength 10 4.4.4 Puncture and tear resistan
22、ce10 4.5 Drapeability.10 4.6 Comfort.11 4.7 Staining, discoloration, and residues .12 4.8 Electrostatic properties .12 4.9 Flammability12 4.10 Generation of particulates and visible lint.13 4.11 Shrinkage.13 4.12 Biocompatibility13 4.13 Sterility assurance13 4.14 Performance in use14 4.15 Strike-thr
23、ough investigation .14 5 Product evaluation and selection of protective apparel and surgical drapes15 5.1 Introduction.15 5.2 Information from manufacturers and suppliers15 5.3 Product evaluation16 5.4 Cost comparisons.16 5.5 Staff input16 5.6 Performance priorities in relation to product function16
24、 5.7 Periodic reassessment17 6 Guidelines for choosing levels of barrier performance needed for particular health care applications.19 6.1 Introduction.19 6.2 Exposure control plan.19 6.3 Classification and labeling of barrier performance by manufacturers19 6.4 Examples of possible barrier performan
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