1、ANSI/AAMI PB70:2012Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilitiesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI
2、 product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of c
3、urrent technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided tha
4、t arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the me
5、asurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance cha
6、racteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test method
7、s to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the rea
8、sons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help
9、 ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, e
10、ven though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide gui
11、delines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practice
12、s. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regul
13、atory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and
14、 industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommen
15、ded practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible dec
16、ision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the spe
17、cific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures
18、and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify
19、 a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed i
20、n the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly use
21、ful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made
22、in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Assoc
23、iation only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommende
24、d practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI PB70:2012 (Revision of ANSI/AAMI PB70:2003/(R)2009) Liquid barrier perfor
25、mance and classification of protective apparel and drapes intended for use in health care facilities Developed 3 May 2012 by Association for the Advancement of Medical Instrumentation Approved 21 June 2012 by American National Standards Institute, Inc. Abstract: This standard establishes a system of
26、 classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. By specifying a consistent basis for testing and labeling protective appare
27、l and drapes and providing a common understanding of barrier properties (e.g., efficacy against liquid or liquid-borne microorganism penetration) based on this new classification system, the standard is intended to ultimately assist end-users in determining the type(s) of protective product most app
28、ropriate for a particular task or situation. Keywords: surgical gowns, surgical drapes, protective apparel, decontamination gowns, other potentially infectious materials (OPIM) AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those
29、substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAM
30、I standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the
31、 date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAM
32、I 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 authorities, in which case the adopting agency is responsible for enf
33、orcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject
34、 to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under fed
35、eral 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, and dam
36、ages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United State
37、s of America ISBN 1570204489 Contents Page Glossary of equivalent standards . v Committee representation vii Acknowledgments viii Foreword . ix 1 Scope 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Normative references . 2 3 Definitions . 2 4 Requirements . 4 4.1 Labeling requirements . 4 4.
38、1.1 Device labeling 4 4.1.2 Package labeling . 5 4.1.3 Technical information 5 4.1.4 Education . 5 4.2 Performance requirements 5 4.2.1 Barrier performance . 5 4.2.2 Tracking mechanism for multiple-use products . 7 4.2.3 Construction 7 5 Tests . 7 5.1 Tests for the labeling requirements 7 5.2 Tests
39、for the performance requirements 7 5.2.1 Barrier performance . 8 5.2.2 Tracking mechanism for multiple-use products . 9 5.2.3 Construction 9 Annexes A Rationale for the development and provisions of this standard 10 15 C Examples of sampling plans . 20 D Bibliography 22 Tables 1 Classification of ba
40、rrier performance of surgical gowns, isolation gowns, other protective apparel, surgical drapes, and drape accessories . 6 B.1 Barrier performance classification of surgical gowns 16 B.2 Barrier performance classification of isolation gowns . 18 B Examples of barrier performance classification of su
41、rgical gowns, isolation gowns, other protective apparel, and surgical drapes E Rationale for changes to the 2003 edition of PB70 26 B.3 Barrier performance classification of surgical drapes . 19 C.1 Sampling plans for sample size code letter G, acceptable quality level (normal inspection) . 21 Figur
42、es B.1 Example of a gown intended for surgical applications 15 B.2 Example of a gown intended for isolation applications . 17 B.3 Example of a surgical drape . 19 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI PB70:2012 v Glossary of equivalent standards International Stan
43、dards 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 level of equivalency to the International Standard. NOTE: Docum
44、ents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Oth
45、er 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. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and
46、 ANSI/AAMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical variations C1 Identical to Corrigendum 1 Mangram, et al., 1999). Surgical gowns, other protective apparel, surgical drapes, and drape accessories are devices intended to promote infection contro
47、l practices and help protect patients and health care workers. This standard is based on key barrier performance tests that are used to classify the subject products into levels of performance. Knowledge of these defined levels of performance will allow informed and consistent choices about the type
48、 of protective product necessary for the situation at hand. This is the second edition of Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, which was first published as an American National Standard in 2003. In comparison to th
49、e first edition, the most significant revisions are allowing the use of the newer WSP 80.3 water-impact resistance test, in addition to the AATCC 42 test; and the addition of “rejectable quality level“ (RQL) criteria in testing of product to determine if the test results are acceptable and product can be released. See also Annex E. As used within the context of this document, “shall” indicates requirements strictly to be followed to conform to the standard. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excl
