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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
25、ce levels for particular applications.19 6.5 Special considerations for isolation gowns22 Glossary of equivalent standardsv 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,
26、02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from IHS -,-,- 7 Care and handling of protective apparel and surgical drapes 22 7.1 Introduction.22 7.2 General considerations.23 7.3 Handling of contaminated protective apparel and surgical drapes at the point of use.23
27、7.4 Disposal of single-use products23 7.5 Processing of multiple-use products.23 7.5.1 Quality assurance program.23 7.5.2 Tracking the number of uses.23 7.5.3 Laundering24 7.5.4 Inspection, testing, folding, and assembly.24 Annexes A Historical background.25 B Test methods.29 C Bibliography .31 Tabl
28、es 1 Example of a product evaluation table.18 2 Classification of barrier performance of surgical gowns, other protective apparel, surgical drapes, and drape accessories20 3 General relationships between barrier performance and anticipated exposure risks .21 4 General relationships between the barri
29、er performance of isolation gowns, mode of disease transmission, and anticipated exposure risks.22 B.1 Summary table of standard test methods that may be used to evaluate safety and performance characteristics29 Figures 1 Bloodborne pathogen size comparison (1.0 M reference sphere)7 2 Bloodborne pat
30、hogen strike-through conversion chart.8 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, 02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from
31、IHS -,-,- Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and le
32、vel of equivalency to the International Standard. NOTEDocuments are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S.
33、 designation Equivalency IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990
34、and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 I
35、dentical IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992
36、 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO
37、 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999 Identical ISO 10993-10:2002 ANSI/AAMI BE78:2002 Minor technical variations ISO 10993-11:1993 ANSI/AAMI 10993-11:1993 Minor technical variations ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/A
38、AMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO TS 10993-19:200x1ANSI/AA
39、MI/ISO TIR10993-19:2006 Identical ISO TS 10993-20:200x1ANSI/AAMI/ISO TIR10993-20:2006 Identical 2006 Association for the Advancement of Medical Instrumentation AAMI TIR11:2005 v Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS
40、Employees/1111111001, User=Japan, IHS Not for Resale, 02/18/2008 01:24:55 MSTNo reproduction or networking permitted without license from IHS -,-,- International designation U.S. designation Equivalency ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:200x1ANSI/AAMI/ISO 11137-1:2006 Ide
41、ntical ISO 11137-2:200x1ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:200x1ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1:1994 ANSI/AAMI ST59:1999 Major technical variations ISO 11138-2:1994 ANSI/AAMI ST21:1999 Major technical variations ISO 11138-3:1995 ANSI/AAMI ST19:1999 Major technical vari
42、ations ISO TS 11139:200x1ANSI/AAMI/ISO 11139:200x Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-5:2000 ANSI/AAMI ST66:1999 Major technical variations ISO 11607-1:200x1ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:200x1ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2
43、00x1ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 13488:1996 ANSI/AAMI/ISO 13488:1996 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identic
44、al ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998 Identical ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical ISO TR 14969:2004 ANSI/AAMI/ISO TIR14969:2004 Identical ISO 14971:2000 and A1:2003 ANSI/AAMI/
45、ISO 14971:2000 and A1:2003 Identical ISO 15223:2000, A1:2002, and A2:2004 ANSI/AAMI/ISO 15223:2000, A1:2001, and A2:2004 Identical ISO 15225:2000 and A1:2004 ANSI/AAMI/ISO 15225:2000 and A1:2004 Identical ISO 15674:2001 ANSI/AAMI/ISO 15674:2001 Identical ISO 15675:2001 ANSI/AAMI/ISO 15675:2001 Ident
46、ical ISO TS 15843:2000 ANSI/AAMI/ISO TIR15843:2000 Identical ISO 15882:2003 ANSI/AAMI/ISO 15882:2003 Identical ISO TR 16142:200x1 ANSI/AAMI/ISO TIR16142:2006 Identical ISO 17664:2004 ANSI/AAMI ST81:2004 Major technical variations ISO 17665-1:200x1ANSI/AAMI/ISO 17665-1:2006 Identical ISO 18472:200x1A
47、NSI/AAMI/ISO 18472:2006 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003 and A1:2005 Identical 1In production vi 2006 Association for the Advancement of Medical Instrumentation AAMI TIR11:2005 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under
48、 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 -,-,- Committee representation Association for the Advancement of Medical Instrumentation AAMI Protective Barriers Committee This technical information report was developed by the AAMI Protective Barriers Committee. Approval of the TIR does not necessarily mean that all committee members voted for its approval. At the time this document was publishe