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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI ST77:2006 Containment devices for reusable medical device sterilization American National Standard Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/
2、1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproduction or networking permitted without license from IHS -,-,- The Objectives and Uses of AAMI Standards and Recommended Practices It is most important that the objectives and potential uses of an AAMI product standard or r
3、ecommended 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 current technologies to
4、 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 that arbitrary and restri
5、ctive 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 con- sidered in qualifying the device for clinical use, and the measurement techniques
6、 that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the per- formance characteristics of different products. Some standards em- phasize the information that should be provided with the device, including performance characteristics, in
7、structions 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 methods to facilitate
8、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 reasons for establi
9、shing 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 ensure that a d
10、evice is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufac- turer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a r
11、ecommended practice is usually oriented towards health care 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 guidelines to in
12、dustrial 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 practices. In determi
13、ning 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 regulatory or proc
14、urement authorities). The application of a standard or recom- mended 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 industrial
15、 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 recommended practic
16、e 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 decision-makin
17、g. 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 specific ratio
18、nale 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 and practic
19、es. 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 equip- ment. No single source of information will serve to identify a partic
20、ular 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 in the con
21、text 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 useful only
22、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 in writin
23、g, to the Manager for Technical Development. 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 Association only upon exhaustio
24、n of any appeals and upon publication of notice of interpre- tation 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 recommended practice which has not
25、 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. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/11
26、11111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproduction or networking permitted without license from IHS -,-,- American National Standard ANSI/AAMI ST77:2006 Containment devices for reusable medical device sterilization Developed by Association for the Advancement of Medic
27、al Instrumentation Approved 2 November 2006 by American National Standards Institute Inc. Abstract: This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument cases, cassettes, and organizing trays. Keywords: containment devices, r
28、eusable rigid sterilization containers, instrument cases, cassettes, organizing trays Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproducti
29、on or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclu
30、de anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This
31、 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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards and recommended practices by
32、 calling or writing AAMI. All AAMI 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. Occasionally, volun
33、tary 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. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arli
34、ngton, VA 222014795 2006 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 part of this document without the prior written permission of the Association f
35、or 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) without the prior written permission of the Association for the Advancement of M
36、edical 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, 1110 N. Glebe Road, Suite 220, Arlington, VA 222014795. Phone: (703) 525-4890; Fax: (7
37、03) 525-1067. Printed in the United States of America ISBN 1570202753 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproduction or networking
38、 permitted without license from IHS -,-,- Contents Glossary of equivalent standardsv Committee representation.vii Foreword.ix Introduction .1 1 Scope.2 1.1 General.2 1.2 Inclusions2 1.3 Exclusions.2 2 Normative references.2 3 Definitions and abbreviations.2 4 Requirements.5 4.1 General.5 4.2 Materia
39、ls of construction.5 4.2.1 Durability 5 4.2.2 Compatibility with the sterilization process .5 4.2.3 Corrosion resistance.5 4.2.4 Biocompatibility.5 4.3 Design.6 4.3.1 General.6 4.3.2 Decontamination.6 4.3.3 Perforations6 4.3.4 Stacking6 4.3.4.1 Internal stacking .6 4.3.4.2 External stacking 6 4.3.5
40、Maximum weight.7 4.3.6 Additional requirements for reusable rigid sterilization containers7 4.3.6.1 Gaskets 7 4.3.6.2 Filters8 4.3.6.3 Valves (if applicable).8 4.3.6.4 Handles 8 4.3.6.5 Lid-base compatibility8 4.3.6.6 Latching mechanisms.9 4.3.6.7 Tamper-evident closure9 4.4 Performance.9 4.4.1 Ster
41、ilization.9 4.4.1.1 Requirements .9 4.4.1.2 Documentation .10 4.4.2 Drying (if applicable).10 4.4.2.1 Requirements .10 4.4.2.2 Documentation .10 4.4.3 Sterilant residual removal (if applicable).11 4.4.3.1 Requirements .11 4.4.3.2 Documentation .11 4.4.4 Sterility maintenance11 4.4.4.1 Requirements .
42、11 4.4.4.2 Documentation .12 4.5 Labeling requirements 12 4.5.1 Device markings.12 4.5.2 Instructions for use.12 5 Tests13 5.1 General.13 5.2 Biocompatibility.13 5.3 Gaskets and filters13 5.4 Valves.13 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license
43、 with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproduction or networking permitted without license from IHS -,-,- 5.5 Handles.13 5.6 Sterilization.14 5.7 Drying (if applicable).15 5.8 Sterilant residual removal (if applicable).15 5.9 Steril
44、ity maintenance 15 Annexes A EO residual removal 17 B Sterilization cycles commonly available in health care facilities.18 C Bibliography.21 Tables 1 Biological indicators for various sterilization processes .14 A.1 Effectiveness and ease of removal of EO residuals from some materials used in typica
45、l medical devices .17 B.1 Parameters for gravity-displacement steam sterilization cycles.18 B.2 Parameters for dynamic-air-removal steam sterilization cycles .19 B.3 Parameters for EO sterilization cycles .19 B.4 Parameters for dry heat sterilization cycles20 B.5 Parameters for hydrogen peroxide gas
46、 plasma sterilization cycles20 B.6 Parameters for ozone sterilization cycles.20 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:50:20 MDTNo reproduction or
47、networking permitted without license from IHS -,-,- 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST77:2006 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each
48、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: Documents are sorted by international designation. Other normatively referenced International Standards may be under
49、 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 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identic