《AAMI-ST8-2008.pdf》由会员分享，可在线阅读，更多相关《AAMI-ST8-2008.pdf（42页珍藏版）》请在三一文库上搜索。
1、Association for the Advancement of Medical Instrumentation ANSI/AAMI ST8:2008 Hospital steam sterilizers Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo reproducti
2、on or networking permitted without license from IHS -,-,- 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 AAMIs technical developm
3、ent 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 is AAMIs view that st
4、andards 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 device recommends to the ma
5、nufacturer 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 measurement techniques that can be used to determine whether the device conforms with the safety and performan
6、ce 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 characteristics, instructions for use, warnings and precautions, and other data considered important in ensurin
7、g 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 represent a considerable part
8、 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 recommended practice provides guid
9、elines 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 will be maintained. Although a
10、 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, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to
11、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, methods of collecting data to
12、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 to the specific needs of a po
13、tential 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 recommended practice is solely within th
14、e 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 sometimes internationally). As suc
15、h, 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 perceived risks and conditions
16、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-making. Despite periodic review and revision (at least once every five years), a standard or recommend
17、ed 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 the document remains relevant to
18、 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 typically form the basis for the sa
19、fety 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 a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decisi
20、on 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 institution or firm. Again, the rational
21、e 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 and policy guidance and in the con
22、text 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 AAMI Vice President, Standards Policy and Programs. An official interpretation must be ap
23、proved 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 interpretation in the “Standard
24、s 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 and which is not
25、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=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo reproduction or networking permit
26、ted without license from IHS -,-,- American National Standard ANSI/AAMI ST8:2008 (Revision of ANSI/AAMI ST8:2001) Hospital steam sterilizers Developed by Association for the Advancement of Medical Instrumentation Approved 4 December 2008 by American National Standards Institute Inc. Abstract: This s
27、tandard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2 cubic feet). Keywords: moist heat sterilization, saturated steam, steam quality, steam sterilization Copyright As
28、sociation for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medic
29、al 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, from manufacturing, marketing, purchasing, or using produc
30、ts, 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. AAMI procedures require that action be taken to reaffirm, rev
31、ise, 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 calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents d
32、eveloped 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 authorities, in which case the adopting agency is resp
33、onsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication,
34、 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 illegal under federal law (17 U.S.C. 101
35、, 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 damages of $100,000 per of
36、fense. 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 1-57020-334-2 Copyright Association for the Advancement of Me
37、dical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standardsv Committee representation.vii Acknowledgments.i
38、x Foreword.x 1 Scope.1 1.1 General.1 1.2 Inclusions1 1.3 Exclusions.1 2 Normative references.1 3 Definitions, symbols, and abbreviations.2 4 Requirements.4 4.1 Labeling4 4.1.1 Device markings.4 4.1.2 Information manual.5 4.1.3 Service manual.5 4.2 Sterilizer design, construction, components, and acc
39、essories6 4.2.1 Pressure requirements .6 4.2.2 Pressure vessel certification.6 4.2.3 Electrical components.6 4.2.4 Corrosion resistance.6 4.2.5 Air filters .6 4.3 Sterilizer safety .6 4.3.1 Interlock6 4.3.2 Prevention of thermal hazards6 4.3.3 Sterilizer controls for aborting cycles6 4.4 Process mon
40、itoring and control devices .7 4.4.1 General.7 4.4.2 Chamber temperature.7 4.4.3 Thermometric test connection 7 4.4.4 Sterilizer exposure timer.7 4.4.5 Pressure measurement 8 4.4.6 Cycle documentation8 4.5 Biological performance of sterilizers .8 4.6 Mechanical air removal.8 4.6.1 Air removal (dynam
41、ic-air-removal sterilizers)8 4.6.2 Air leaks (prevacuum sterilizers).8 4.7 Sterilizer performance certification and recordkeeping .8 5 Tests9 5.1 Labeling9 5.2 Sterilizer design, construction, components, and accessories9 5.2.1 Pressure requirements .9 5.2.2 Pressure vessel certification.9 5.2.3 Ele
42、ctrical components.9 5.2.4 Corrosion resistance.9 5.2.5 Air filters .9 5.3 Sterilizer safety .9 5.3.1 Interlock9 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo re
43、production or networking permitted without license from IHS -,-,- 5.3.2 Prevention of thermal hazards9 5.3.3 Sterilizer controls for aborting cycles10 5.4 Process monitoring and control devices .10 5.4.1 General.10 5.4.2 Chamber temperature.10 5.4.3 Thermometric test connection 10 5.4.4 Sterilizer e
44、xposure timer.10 5.4.5 Pressure measurement 10 5.4.6 Cycle documentation10 5.5 Biological performance of sterilizers .11 5.5.1 General testing requirements .11 5.5.2 Biological performance with a fabric PCD.11 5.5.3 Biological performance with liquid loads (if applicable).13 5.5.4 Biological perform
45、ance with wrapped instrument PCD.14 5.5.5 Biological performance of abbreviated (flash) cycles for single-wrapped or unwrapped nonporous items.16 5.6 Mechanical air remova testsl 17 5.6.1 Air removal test (dynamic-air-removal sterilizers).17 5.6.2 Air leak-rate test (prevacuum sterilizers) 21 5.7 St
46、erilizer performance certification and recordkeeping .21 Annexes A Rationale for the development and provisions of this standard22 B Examples of cycle documentation26 C Bibliography .30 Tables 1 Conversions of saturated pressure units at sea level4 Figures 1 Preparation of the fabric (16-towel) PCD
47、12 2 Placement of fabric (16-towel) PCD for qualification testing of gravity-displacement steam sterilizers.12 3 Example of a surgical instrument tray to be used in the wrapped instrument PCD.15 4 Surgical instrument tray (25 cm by 51 cm 10 inches by 20 inches) and wrapper (137 cm by 137 cm 54 inche
48、s by 54 inches) for use in the wrapped instrument PCD15 5 Composition of the Bowie-Dick test pack18 6 Placement of the Bowie-Dick test pack.19 7 Time-temperature profile of temperature sensor T1.20 B.1 Schematic of a cycle.26 B.2 Example of a cycle printout.27 B.3 Example of a cycle printout.28 B.4
49、Example of cycle printout information .29 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=HP Monitoring/1111111164 Not for Resale, 04/07/2009 05:42:15 MDTNo reproduction or networking permitted without license from IHS -,-,- Glossary of equivalent standards In