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1、American National Standard ANSI/AAMI ST8:2001 AAMI Association for the Advancement of Medical Instrumentation Hospital steam sterilizers Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie N
2、ot for Resale, 10/17/2007 02:51:42 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 recommended practice are clearly
3、 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 patient care, and (2) the enco
4、uragement 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 restrictive uses are avoided. A volun
5、tary 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 that can be used to determine
6、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, instructions for use, warnings an
7、d 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 uniformity in reporting; reachi
8、ng 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 establishing the criteria must be docu
9、mented 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 device is used safely and effect
10、ively 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 fume of reference for device evaluation. Similarly, even though a recommended practice is usually o
11、riented 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 industrial personnel on such subje
12、cts 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 determining whether an AAMI standard or
13、 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 procurement authorities). The applic
14、ation 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 representatives, whose work has
15、 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 practice is limited, however, in the se
16、nse 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 decisionmaking. Despite periodic review and re
17、vision (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 rationale for each of its provisions.
18、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 practices. While observed or potential r
19、isks 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 particular product as “unsafe“. A volun
20、tary 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 context of the specific needs and re
21、sources 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 when it is used in conjunction wi
22、th 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 writing, to the Manager for Technical D
23、evelopment. 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 exhaustion of any appeals and upon publica
24、tion 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 been developed and communicated
25、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/1111111001, User=Wing, Bernie Not f
26、or Resale, 10/17/2007 02:51:42 MDTNo reproduction or networking permitted without license from IHS -,-,- American National StandardANSI/AAMI ST8:2001 (Revision of ANSI/AAMI ST8:1994) Hospital steam sterilizers Developed by Association for the Advancement of Medical Instrumentation Approved 11 Novemb
27、er 2001 by American National Standards Institute, Inc. Abstract:This standard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 2 cubic feet. Keywords:moist heat sterilization, saturated
28、steam, steam sterilization 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, 10/17/2007 02:51:42 MDTNo reproduction or networking permitted without license from IHS -,-,- A
29、AMI 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 preclude anyone, whether they have approved the standard or not,
30、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 AAMI standard may be revised or withdrawn at any time. AAM
31、I 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 by calling or writing AAMI. All AAMI standards, recommended practices, technical inform
32、ation 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 agencies or procurement
33、 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 Arlington, VA 22201-4795 2002 by the Association for the Advancement of Medical Instrumen
34、tation 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 for the Advancement of Medical Instrumentation is strictly prohibited by law. It is i
35、llegal 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 Medical Instrumentation. Violators risk legal action, including civil and criminal pe
36、nalties, and 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 1570201722 Copyright A
37、ssociation for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:51:42 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representation.
38、 v Acknowledgmentvii Foreword .viii 1Scope.1 1.1General1 1.2Inclusions 1 1.3Exclusions.1 2Normative references.1 3Definitions, symbols, and abbreviations.2 Table 1Conversions of saturated pressure units at sea level3 4Requirements.4 4.1Labeling.4 4.1.1Device markings .4 4.1.2Information manual .4 4.
39、1.3Service manual .4 4.2Sterilizer design, construction, components, and accessories5 4.2.1Pressure requirements5 4.2.2Pressure vessel certification .5 4.2.3Electrical components.5 4.2.4Corrosion resistance.5 4.2.5Air filters5 4.3Sterilizer safety5 4.3.1Interlock 5 4.3.2Prevention of thermal hazards
40、5 4.3.3Sterilizer controls for aborting cycles 5 4.4Process monitoring and control devices5 4.4.1General .5 4.4.2Chamber temperature.6 4.4.3Thermometric test connection.6 4.4.4Sterilizer exposure timer .6 4.4.5Pressure measurement.6 4.4.6Cycle documentation 7 4.5Biological performance of sterilizers
41、7 4.6Mechanical air removal .7 4.6.1Air removal (dynamic-air-removal sterilizers)7 4.6.2Air leaks (prevacuum sterilizers).7 4.7Sterilizer performance certification and recordkeeping.7 5Tests 7 5.1Labeling.8 5.2Sterilizer design, construction, components, and accessories8 5.2.1Pressure requirements8
42、5.2.2Pressure vessel certification .8 5.2.3Electrical components.8 5.2.4Corrosion resistance.8 5.2.5Air filters8 5.3Sterilizer safety8 5.3.1Interlock 8 5.3.2Prevention of thermal hazards8 5.3.3Sterilizer controls for aborting cycles 8 5.4Process monitoring and control devices8 5.4.1General .8 Copyri
43、ght Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:51:42 MDTNo reproduction or networking permitted without license from IHS -,-,- 5.4.2Chamber temperature.9 5.4.3Th
44、ermometric test connection.9 5.4.4Sterilizer exposure timer .9 5.4.5Pressure indicators .9 5.4.6Cycle documentation 9 5.5Biological performance of sterilizers9 5.5.1General testing requirements9 5.5.2Biological performance with a fabric test pack10 Annexes ARationale for the development and provisio
45、ns of this standard .20 BExamples of cycle documentation24 CBibliography .28 Tables 1Conversions of saturated pressure units at sea level 3 Figures 1Preparation of the 16-towel BI test pack 10 2Placement of a BI test pack for qualification testing of gravity-displacement steam sterilizers11 3Example
46、 of a surgical instrument tray to be used in the wrapped instrument test.13 4Surgical instrument tray (20 in by 10 in) and wrapper (54 in by 54 in) for use in the wrapped instrument test pack.13 5Composition of the Bowie-Dick test pack.16 6Placement of the Bowie-Dick test pack17 7Time/temperature pr
47、ofile of temperature sensor T1.18 B.1 Schematic of a cycle24 B.2 Example of a cycle printout25 B.3 Example of a cycle printout26 B.4 Example of cycle printout information 27 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Empl
48、oyees/1111111001, User=Wing, Bernie Not for Resale, 10/17/2007 02:51:42 MDTNo reproduction or networking permitted without license from IHS -,-,- 2002 Association for the Advancement of Medical Instrumentation ? ANSI/AAMI ST8:2001v Committee representation Association for the Advancement of Medical
49、Instrumentation AAMI Sterilization Standards Committee This standard was developed by the AAMI Hospital Steam Sterilizer Working Group under the auspices of the AAMI Sterilization Standards Committee. Approval of the standard does not necessarily imply that all working group members voted for its approval. At the time thi