1、ANSI/AAMI/ST15883-3: 2012(ISO 15883-3:2006, MOD) Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containersAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the
2、 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 instrumentation. Essential to such advancement are (1) a continued increase i
3、n 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 advancement of medical instrumentation, provided that they are drafted with atten
4、tion 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, basic safety and performance criteria that should be considered in qualifyin
5、g 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 products. Some standards emphasize the information that should be provided w
6、ith 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. Recommending the disclosure of performance characteristics often necessitates t
7、he 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 concerns warrant the establishment of minimum safety and performance criteria, r
8、eferee 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 recommended practice does not address device performance per se, but rathe
9、r 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 value to the potential purchaser or user of the device as a frame of refe
10、rence 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 device will be used. Also, some recommended practices, while not addressing
11、 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 evaluation techniques; such guidelines may be useful to health care professio
12、nals 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: All AAMI standards and recommended practices are voluntary (unless, of cou
13、rse, 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 standard or recommended practice reflects the collective expertise of a c
14、ommittee 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 practice are intended to respond to clinical needs and, ultimately, to help ensu
15、re 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 recommended practice is an important reference in responsible decision-making, bu
16、t 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. Therefore, a standards user must carefully review the reasons why the doc
17、ument 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 product standard to existing devices and equipment, and in applying a re
18、commended 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 must be used in applying these criteria to existing equipment. No single sou
19、rce 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 its utilization and, of course, cost-benefit considerations. Similarly, a
20、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 guide to the reasoning and data underlying its provision. In summary, a stan
21、dard 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 STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standard
22、s 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 and approved by the AAMI Standards Board. The interpretation will become
23、 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 Medical Instrumentation disclaims responsibility for any characterization o
24、r 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 News. American National Standard ANSI/AAMI ST15883-3:2012 (ISO 15883-3:2006
25、, MOD) Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers Approved 3 December 2013 by Association for the Advancement of Medical Instrumentation Approved 10 December 2013 by American National Standards Institute, Inc.
26、Abstract: This document specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. Keywords: ISO 15883-3 AAMI Standard This Associati
27、on 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, from manufacturing, marketi
28、ng, 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. AAMI procedures require that a
29、ction 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, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended pract
30、ices, 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, voluntary technical documents are adopted by government regulatory a
31、gencies 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 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for
32、the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All
33、 requests pertaining to this document should be submitted to AAMI. 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 Medical Ins
34、trumentation. 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, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington,
35、VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-482-9 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI adoption of ISO 15883-3:2006 viii U.S. Deviations to ISO 15883-3:2006 ix Forewo
36、rd xii Introduction xiii 1 Scope. 1 2 Normative references 1 3 Terms and definitions 1 4 Performance requirements . 2 5 Mechanical and control requirements . 4 6 Testing for conformity . 5 7 Information to be supplied by the manufacturer 7 8 Information to be requested from the purchaser by the supp
37、lier of the WD . 7 Annex A (informative) Summary of test programs . 8 Annex B (normative) Specification for toilet tissue for use in tests on washer-disinfectors for human-waste containers . 9 Annex C (informative) Measurement of water absorbency of toilet tissue by the basket method . 10 Bibliograp
38、hy 11 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-3:2012 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 Internation
39、al Standard 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 Ins
40、trumentation ANSI/AAMI ST15883-3:2012 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 Steriliza
41、tion Standards 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
42、13) played 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 supports for single-use bed pans; hospital bowls; urine bottles; suction bottles; and products si
43、milar to the above and used for similar purposes. Fields of application within the scope of the ISO AAMI ST15883 series of standards include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts a
44、nd 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 the ISO AAMI ST15883 series of standards. Bedpan washer disinfectors are loaded manually. In order to reduc
45、e the risk of spillage and the generation of aerosols most machines incorporate means to empty human waste containers automatically e.g. by the action of closing the door. Where equipment does not provide automatic emptying facilities, extra care is needed by the user to avoid exposure to human wast
46、e and contamination of the work environment including the generation of aerosols. The reliability of a bedpan washer-disinfector may be adversely affected if the machine is connected to a poorly designed or constructed drainage system. The purchaser is therefore recommended to ensure that the draina
47、ge system complies with the manufacturers recommendations in all respects. Safety requirements for washer-disinfectors are given in IEC 61010-2-0405. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfectors: a) note that unt
48、il verifiable European criteria are adopted, existing national regulations concerning the use and/or the characteristics of the washer-disinfectors remain in force; xiv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-3:2012 b) this part of ISO 15883 provides no info
49、rmation as to whether the washer-disinfectors may be used without restriction in any of the member states of the EU or EFTA. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST15883-3:2012 1 American National Standard ANSI/AAMI ST15883-3:2012 Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers 1 Scope This part of ISO AAMI ST15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, clean
