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1、 American National Standard ANSI/AAMI ST55:2003 Table-top steam sterilizers 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 understood. The objectives of AA
2、MIs 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 encouragement of new technologies. It
3、 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 voluntary standard for a medical devic
4、e 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 whether the device conforms with
5、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 and precautions, and other data con
6、sidered 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; reaching consensus on these tests can r
7、epresent 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 documented in the rationale. A recomm
8、ended 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 effectively and that its performance wi
9、ll 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 oriented towards health care profe
10、ssionals, 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 subjects as sterilization processing,
11、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 recommended practice is relevant
12、 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 application of a standard or recom- men
13、ded 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 been reviewed nationally (and so
14、metimes 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 sense that it responds generally to
15、 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 revision (at least once every five
16、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. This review will reveal whether t
17、he 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 risks with existing equipment typi
18、cally 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 voluntary standard can be used as one
19、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 resources of the individual institu
20、tion 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 with other sources of information a
21、nd 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 Development. An official interpret
22、ation 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 publication of notice of interpre- tatio
23、n 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 in accordance with this procedure
24、 and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI ST55:2003 (Revision of ANSI/AAMI ST55:1997) Table-top steam sterilizers Developed by Association for the Advancement of Medical Instrumentation Approved 30 Decembe
25、r 2003 by American National Standards Institute, Inc. Abstract: This standard establishes minimum construction and performance requirements for small table- top steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 2 cubic feet. Keywords: mo
26、ist heat sterilization, process monitoring, saturated steam, steam sterilization 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 no
27、t 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. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest edition
28、s. 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 date of publication. Interested parties may obtain current information on all AAMI standards by
29、 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
30、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
31、ngton, VA 22201-4795 2004 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
32、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 or externally) without the prior written permission of the Association for the Advancement of
33、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, contact AAMI at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax
34、: (703) 525-1067. Printed in the United States of America ISBN 1570202192 Contents Page Glossary of equivalent standardsvi Committee representation. viii Forewordx 1 Scope1 1.1 General 1 1.2 Inclusions.1 1.3 Exclusions1 2 Normative references1 3 Definitions, symbols, and abbreviations2 4 Requirement
35、s3 4.1 Labeling3 4.1.1 Device markings 3 4.1.2 Information manual4 4.1.3 Service manual4 4.2 Sterilizer design, construction, components, and accessories .4 4.2.1 Pressure requirements.4 4.2.2 Pressure vessel certification 4 4.2.3 Electrical components4 4.2.4 Corrosion resistance5 4.2.5 Air filters.
36、5 4.2.6 Water supply reservoir.5 4.3 Sterilizer safety.5 4.3.1 Interlock.5 4.3.2 Prevention of thermal hazards.5 4.3.3 Sterilizer controls for aborting cycles .5 4.4 Process monitoring and control devices.5 4.4.1 Chamber temperature5 4.4.2 Sterilizer temperature control.6 4.4.3 Thermometric test con
37、nection6 4.4.4 Sterilizer exposure timer 6 4.4.5 Pressure measurement6 4.4.6 Cycle completion6 4.4.7 Sterilization fault conditions .6 4.4.8 Cycle documentation .6 4.5 Biological performance of sterilizers.7 4.6 Mechanical air removal 7 4.6.1 Air removal (dynamic-air-removal sterilizers).7 4.6.2 Air
38、 leaks (prevacuum sterilizers)7 4.6.3 Air removal (gravity-displacement cycles)7 4.7 Moisture retention 9 4.8 Sterilizer performance certification and recordkeeping.9 5 Tests.10 5.1 Labeling10 5.2 Sterilizer design, construction, components, and accessories .10 5.2.1 Pressure requirements.10 5.2.2 P
39、ressure vessel certification 10 5.2.3 Electrical components10 5.2.4 Corrosion resistance10 5.2.5 Air filters.10 5.2.6 Water supply reservoir.10 5.3 Sterilizer safety.10 5.3.1 Interlock.10 5.3.2 Prevention of thermal hazards.11 5.3.3 Sterilizer controls for aborting cycles .11 5.4 Process monitoring
40、and control devices.11 5.4.1 Chamber temperature11 5.4.2 Sterilizer temperature control.11 5.4.3 Thermometric test connection11 5.4.4 Sterilizer exposure timer 11 5.4.5 Pressure measurement11 5.4.6 Cycle completion11 5.4.7 Sterilization fault conditions .11 5.4.8 Cycle documentation .12 5.5 Biologic
41、al performance of sterilizers.12 5.5.1 General testing requirements.12 5.5.2 Biological performance with a textile PCD (BI test pack) .12 5.5.3 Biological performance with liquid loads (if applicable) 14 5.5.4 Biological performance with wrapped instrument PCD (BI test tray)15 5.5.5 Biological perfo
42、rmance with dental handpieces .16 5.6 Mechanical air removal 17 5.6.1 Air removal (dynamic-air-removal sterilizers).17 5.6.2 Air leaks (prevacuum sterilizers)17 5.6.3 Air removal (gravity-displacement sterilizers).18 5.7 Moisture retention 18 5.7.1 Textile test packs.18 5.7.2 Wrapped instrument test
43、 trays.20 5.7.3 Paperplastic peel pouches.20 5.8 Sterilizer performance certification and recordkeeping.21 Annexes A Rationale for the development and provisions of this standard.22 B Examples of temperature during the holding time.26 C Examples of cycle documentation.29 D Bibliography 33 Table 1 Pr
44、operties of saturated steam at sea level (courtesy of Spirax Sarco, Inc.)8 Figures 1 Three-towel PCD (BI test pack) for textile load .13 2 Towel folding procedure13 3 Completed wrapped textile PCD (BI test pack).14 4 Folding a surgical towel to yield nine plies (see 5.7.1.1) .19 5 Example of single-
45、 and double-packaging with paperplastic pouches.20 B.1 Unacceptable process.26 B.2 Unacceptable process.26 B.3 Unacceptable process.27 B.4 Unacceptable process.27 B.5 Acceptable process.27 B.6 Acceptable process.28 C.1 Schematic of cycle phases29 C.2 Example of a cycle printout.30 C.3 Example of a c
46、ycle printout.31 C.4 Example of cycle printout information .32 vi 2004 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST55:2003 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standa
47、rds. 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. NOTEDocuments are sorted by international designation. Other normatively referenced International Standards
48、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 60601-1-2:2001 ANSI/AAMI/IEC 60601-1-2:2001 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 6060
49、1-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 “should” indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is used to indicate that a course of action is permissible within the limits of the standard; and “can” is used as a statement of possibility and capability. “Must” is used only to describe
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