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1、ANSI/AAMI RD62:2006 hemodialysis applications Water treatment equipment for American National Standard Association for the Advancement of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111
2、1001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- 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 recomme
3、nded 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 technologies to patie
4、nt 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 restrictive
5、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 techniques that
6、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 characteristics, instruct
7、ions 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 facilitate unifor
8、mity 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 establishing
9、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 that a device
10、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 frame of reference for device evaluation. Similarly, even though a recomme
11、nded 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 to industri
12、al 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 determining w
13、hether 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 procuremen
14、t 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 industrial repre
15、sentatives, 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 practice is l
16、imited, 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 decision-making. Des
17、pite 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 rationale f
18、or 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 practices. Wh
19、ile 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 particular p
20、roduct 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 context o
21、f 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 only when i
22、t 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 writing, to
23、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 exhaustion of a
24、ny 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 not been
25、developed and communicated in accordance with this procedure and which is not 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=IHS Employees/11111110
26、01, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Water treatment equipment for hemodialysis applications Developed by Association for the Advancement of Medical Instrumentation Approved 5 December 2006 by American Nat
27、ional Standards Institute, Inc. Abstract: This American National Standard addresses devices used to treat water intended for use in the delivery of hemodialysis. Included in the scope of the standard is water used for (1) the preparation of concentrates from powder at a dialysis facility, (2) the pr
28、eparation of dialysate, and (3) the reprocessing of dialyzers for multiple use. Keywords: dialysis, water quality, concentrates, dialyzing fluids, medical equipment, reuse American National Standard ANSI/AAMI RD62:2006 (Revision of ANSI/AAMI RD62:2001) Copyright Association for the Advancement of Me
29、dical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentati
30、on (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 products, processes, o
31、r 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, revise, or withdraw
32、 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. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI ar
33、e 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 for enforce
34、ment of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storag
35、e, 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, et seq.) to make copies of all or
36、 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 offense. For permission regarding the
37、 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 157020277X Copyright Association for the Advancement of Medical Instrumentation Provided by IHS
38、under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Glossary of equivalent standards .v Committee representation vii Foreword . viii 1 Scope1 1.1 Gener
39、al 1 1.2 Inclusions .1 1.3 Exclusions 1 2 Normative references2 3 Terms and definitions2 4 Requirements4 4.1 Product water quality requirements 4 4.1.1 Water bacteriology .4 4.1.2 Maximum level of chemical contaminants4 4.2 Water treatment equipment requirements 5 4.2.1 General 5 4.2.2 Materials com
40、patibility6 4.2.3 Disinfection protection6 4.2.4 Safety requirements.6 4.2.5 Regenerated or reconstituted devices .6 4.2.6 Deionization .7 4.2.7 Reverse osmosis .7 4.2.8 Filters .7 4.2.9 Carbon adsorption media.7 4.2.10 Automatically regenerated water softeners 8 4.2.11 Storage tanks.8 4.2.12 Endoto
41、xin-retentive filters 8 4.2.13 Ultraviolet irradiators 8 4.2.14 Hot water disinfection systems.9 4.2.15 Ozone disinfection systems .9 4.2.16 Tempering valves.9 4.2.17 Piping systems.9 4.2.18 Backflow prevention device9 5 Tests .9 5.1 Compliance with product water quality requirements .9 5.1.1 Water
42、bacteriology .10 5.1.2 Maximum level of chemical contaminants .10 5.2 Compliance with water treatment equipment requirements11 5.2.1 General 11 5.2.2 Materials compatibility12 5.2.3 Disinfection protection12 5.2.4 Safety requirements.12 5.2.5 Regenerated or reconstituted devices .12 5.2.6 Deionizati
43、on .12 5.2.7 Reverse osmosis .12 5.2.8 Filters .12 5.2.9 Carbon adsorption media.12 5.2.10 Automatically regenerated water softeners 13 5.2.11 Storage tanks.13 5.2.12 Endotoxin-retentive filters 13 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license wit
44、h AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- 5.2.13 Ultraviolet irradiators 13 5.2.14 Hot water disinfection systems.13 5.2.15 Ozone disinfection systems .13 5.2.16 Tempering
45、valves.13 5.2.17 Piping systems.13 5.2.18 Backflow prevention devices13 6 Labeling 13 6.1 Device markings.13 6.2 Product literature14 Annex Tables 1 Maximum allowable chemical contaminant levels in water used to prepare dialysate A Rationale for the development and provisions of this standard .16 an
46、d concentrates from powder at a dialysis facility and to reprocess dialyzers for multiple use5 2 Analytical tests for chemical contaminants11 Bibliography .28 ? Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111
47、001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each Inter
48、national 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. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under cons
49、ideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2001 and ANSI/AAMI/IEC 60601-1-2:2001 and Identical Amendment 1:2004 Amendment 1:2004 IEC 60601-2