1、ANSI/AAMI/ST15883-2: 2013(ISO 15883-2:2006, MOD) Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.American National StandardObjectives and uses
2、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 development program derive from AAMIs overall mission: the advancement of medical inst
3、rumentation. 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 standards and recommended practices can contribute significantly to the advancem
4、ent 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 manufacturer the information that should be provided with or on the product, bas
5、ic 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 performance criteria and/or to compare the performance characteristics of different pro
6、ducts. 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 ensuring the safe and effective use of the device in the clinical environment. Recomm
7、ending 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 of committee work. When a drafting committee determines that clinical concern
8、s 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 guidelines for the use, care, and/or processing of a medical device or system. A r
9、ecommended 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 device standard is primarily directed to the manufacturer, it may also be of
10、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 the manufacturer in better understanding the environment in which a medical de
11、vice 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 establish safety and efficacy, human engineering, and other processing or eval
12、uation 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 potential user of the document, several important concepts must be recognized: A
13、ll 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 the discretion and professional judgment of the user of the document. Each AAMI
14、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 such, the consensus recommendations embodied in a standard or recommended practic
15、e 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 that may not always be relevant to specific situations. A standard or recommen
16、ded 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 recommended practice is necessarily a static document applied to a dynamic technology.
17、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 the specific needs of the user. Particular care should be taken in applying a
18、 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 safety and performance criteria defined in a standard, professional judgment mus
19、t 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 decision as to product safety and efficacy must take into account the specifics of i
20、ts 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 rationale accompanying each AAMI standard and recommended practice is an excellent gui
21、de 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 context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARD
22、S 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 approved by letter ballot of the originating committee and subsequently reviewed
23、 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 “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Me
24、dical 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 published, by appropriate notice, as an official interpretation in the AAMI Ne
25、ws. American National Standard ANSI/AAMI ST15883-2:2013 (ISO 15883-2:2006, MOD) Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Approved 3 Dec
26、ember 2012 by Association for the Advancement of Medical Instrumentation Approved 9 January 2013 by American National Standards Institute, Inc. Abstract: This document specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection,
27、in a single operating cycle, of re-usable medical devices such as surgical instruments, anesthetic equipment, bowls, dishes and receivers, utensils and glassware. Keywords: ISO 15883-2 AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus o
28、f 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 products, processes, or procedures not conforming to the stand
29、ard. 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, revise, or withdraw this standard no later than 5 years fro
30、m the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed b
31、y 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 responsible fo
32、r enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subj
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35、damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United Stat
36、es of America ISBN 1-57020-481-0 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI adoption of ISO 15883-2:2006 viii U.S. Deviations to ISO 15883-2:2006 ix Foreword . xiv Introduction . xv 1 Scope. 1 2 Normative references 1 3 Terms and definitions
37、2 4 Performance requirements . 3 4.1 General 3 4.2 Cleaning 4 4.3 Disinfecting . 4 4.4 Temperature of internal surfaces of processed devices . 5 5 Mechanical and control requirements . 5 5.1 Load connectors 5 5.2 Control systems . 6 5.3 Process verification . 6 6 Testing for conformity . 6 6.1 Gener
38、al 6 6.2 Tests for soil removal from chamber walls, load carrier and load . 6 6.3 Thermometric tests 7 7 Information to be supplied by the manufacturer 9 8 Information to be requested from the purchaser by the supplier of the WD . 9 Annex A (informative) Summary of test programs 11 Bibliography 12 i
39、v 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-2:2013 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Stan
40、dard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2013 Association for the Advancement of Medical Instrument
41、ation ANSI/AAMI ST15883-2:2013 v Committee representation Association for the Advancement of Medical Instrumentation Washer-disinfectors Working Group The adoption of ISO 15883-2 as an American National Standard was initiated by the AAMI Washer-disinfectors Working Group of the AAMI Sterilization St
42、andards Committee. The AAMI Washer-disinfectors Working Group also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). U.S. representatives from the AAMI Washer-disinfectors Working Group (U.S. Sub-TAG for ISO/TC 198/WG 13) pla
43、yed an active part in developing the ISO standard. At the time this document was published, the AAMI Washer-disinfectors Working Group had the following members: Cochairs: Kevin Corrigan, Johnson powered devices; instrument trays; instruments for minimally invasive surgery; lumen devices and tubing;
44、 rigid endoscopes; anesthetic and respiratory equipment; bowls, dishes and receivers; glassware; containers for transit. Fields of application within the scope of the ISO AAMI ST15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications and other specific applic
45、ations, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Requirements for washer-disinfectors for other applications are specified in other parts of the ISO AAMI ST15883 series of st
46、andards. When processed in the instrument washer-disinfector, the medical devices might be intended for immediate use or might be intended for packing and sterilization. In both cases, the efficacy of the cleaning and disinfection is of major importance. In either case, this is for the well being of
47、 the patient. In the latter case, it is also for the safety of the staff who handles the instruments in the process of inspection, testing and packing as well as ensuring that the sterilization process is not unduly challenged by residual soil. The efficacy of disinfection can be impaired if soil re
48、moval is incomplete before the start of the disinfection process. Users should be aware that sSome medical devices might require pre-treatment e.g. soaking, brushing, ultrasonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made to the medical manufacture
49、rs instructions for reprocessing (see also ISO 17664 or ANSI/AAMI ST81). xvi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-2:2013 Safety requirements for washer-disinfectors are given in IEC 61010-2-0405. Requirements for the quality of water employed to process surgical instruments and related devices are found in AAMI TIR34. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) it should be noted that, until verifiable European crite
