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1、 American National Standard ANSI/AAMI ST50:2004 AAMI Association for the Advancement of Medical Instrumentation Dry heat (heated air) 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 standar
2、d 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 current technolog
3、ies 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 that arbitrary and
4、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 con- sidered in qualifying the device for clinical use, and the measurement tech
5、niques 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 characteristi
6、cs, 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 methods to facil
7、itate 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 e
8、stablishing 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 th
9、at a device 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 fume of reference for device evaluation. Similarly, even thoug
10、h a recommended 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
11、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 practices. In de
12、termining 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
13、 procurement 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 indus
14、trial 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 pr
15、actice 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 decisionm
16、aking. 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 r
17、ationale 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 pra
18、ctices. 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 pa
19、rticular 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
20、 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 useful o
21、nly 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 wr
22、iting, 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 exhau
23、stion 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
24、 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 ST50:2004 (Revision of ANSI/AAMI ST50:1995) Dry heat (heated air) sterilizers Developed by As
25、sociation for the Advancement of Medical Instrumentation Approved 7 April 2004 by American National Standards Institute, Inc. Abstract: This standard establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and medical offices, labora
26、tories, ambulatory-care clinics, hospitals, and other health care facilities. Keywords: dry heat 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 existen
27、ce 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. AAMI standards are subject to periodic review, and users are cautione
28、d 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 date of publication. Interested parties may obtain current inform
29、ation on all AAMI standards and recommended practices by 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 j
30、udgment 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 enforcement of its rules and regulations. Published by Association for the Advancement of Me
31、dical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, 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
32、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, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior writt
33、en 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 offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220
34、, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202133 Contents Page Glossary of equivalent standards.v Committee representationvii Acknowledgment. viii Foreword.ix 1 Scope1 1.1 General 1 1.2 Inclusions.1 1.3 Exclusions1 2 Norm
35、ative references1 3 Definitions of terms .1 4 Requirements3 4.1 Labeling3 4.1.1 Device markings 3 4.1.2 Information manual3 4.1.3 Service manual4 4.2 Electrical components4 4.3 Loading accessories 4 4.4 Prevention of thermal hazards .4 4.5 Sterilizer controls for aborting cycles4 4.6 Process control
36、 and monitoring devices.4 4.6.1 Chamber temperature4 4.6.2 Sterilizer exposure timer 5 4.6.3 Airflow5 4.6.4 Cooling.5 4.7 Biological performance of sterilizers.5 4.8 Certification and record-keeping 5 4.9 Software quality assurance 5 4.9.1 Software developed in-house.5 4.9.2 Custom-developed softwar
37、e 5 4.9.3 Off-the-shelf software.6 5 Tests.6 5.1 Labeling6 5.2 Electrical components6 5.3 Loading accessories 6 5.4 Prevention of thermal hazards .6 5.5 Sterilizer controls for aborting cycles6 5.6 Process control and monitoring devices.6 5.6.1 Chamber temperature6 5.6.2 Sterilizer exposure timer 7
38、5.6.3 Airflow7 5.6.4 Cooling.7 5.7 Biological performance of sterilizers.7 5.7.1 General considerations7 5.7.2 Biological-indicator challenge test pack .7 5.7.3 Simulated-use tests .8 5.8 Certification and record-keeping 8 5.9 Software quality assurance 8 Annexes A Rationale for the development and
39、provisions of this standard.9 B Example of a biological-indicator challenge test pack for dry heat sterilizers15 C Bibliography 28 Tables B.1 Temperature profile for Sterilizer A (1 hour cycle).16 B.2 Temperature profile for Sterilizer A (30 minute cycle)16 B.3 BI and CI results for Sterilizer A 17
40、B.4 BI and CI results for Sterilizer B 19 B.5 Temperature profile for Sterilizer C (half-cycle).20 B.6 BI and CI results for Sterilizer C 22 B.7 Temperature profile for Sterilizer D (test #1) .24 B.8 Temperature profile for Sterilizer D (test #2) .24 B.9 Temperature profile for Sterilizer D (test #3
41、) .25 B.10 BI and CI results for Sterilizer D 25 Figures A.1 Batch cycle: Convective dry heat (static air)10 A.2 Batch cycle: Convective dry heat (forced air) with chamber heat continuously maintained.11 A.3 Batch cycle: Convective dry heat (forced air); load remains in chamber during cool-down .11
42、B.1 Load configuration for Sterilizer A16 B.2 Load configuration for Sterilizer B17 B.3 Temperature profile for BI challenge test pack and instrument rack for Sterilizer B (12 minute cycle).18 B.4 Temperature profile for BI challenge test pack and instrument rack for Sterilizer B (6 minute cycle).18
43、 B.5 Load configuration for Sterilizer C .20 B.6 Temperature profile for Sterilizer C (half-cycle).21 B.7 Temperature profile for Sterilizer C (standard cycle).22 B.8 Load configuration for Sterilizer D (test #1) .23 B.9 Load configuration for Sterilizer D (test #2) .23 B.10 Load configuration for S
44、terilizer D (test #3) .24 B.11 Temperature profile for Sterilizer D (46 minute cycle) .25 B.12 Temperature profile for Sterilizer D (18 minute cycle) .26 B.13 Temperature profile for Sterilizer D (16.5 minute cycle) 27 2004 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST50:
45、2004 v Glossary of equivalent standards International Standards 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
46、 of equivalency to the International Standard. NOTEDocuments are sorted by international designation. Other 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. de
47、signation 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 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 “should” indicates that among several possibilities one is recommended as particularly
48、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 permi
49、ssible within the limits of the recommended practice; and “can” is used as a statement of possibility and capability. “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation. This standard should be considered flexible and dynamic. As technology advances and new data is brought forward, the standard will be reviewed and, if necessary, revised. AAMI policies and procedures require that AAMI standards and recommended practices be reviewed and, if necessary, revised at least once every 5 years. Suggestions for improving this sta
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