《AAMI-RD52-2004.pdf》由会员分享，可在线阅读，更多相关《AAMI-RD52-2004.pdf（53页珍藏版）》请在三一文库上搜索。
1、 American National Standard ANSI/AAMI RD52:2004 Dialysate for hemodialysis Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:37 MDTNo reproduction or netwo
2、rking 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 recommended practice are clearly understood. The objectives of AAMIs technical development pro
3、gram 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 standards
4、 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 manufactu
5、rer 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 can be used to determine whether the device conforms with the safety and performance cr
6、iteria 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, instructions for use, warnings and precautions, and other data considered important in ensuring
7、 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 guide
9、lines 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 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 though a recommended practice is usually oriented towards health care 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 p
13、otential 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 recom- mended practice is solely within
14、 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 representatives, whose work has been reviewed nationally (and sometimes internationally). As
15、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 limited, however, in the sense that it responds generally to perceived risks and conditio
16、ns 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 decisionmaking. Despite periodic review and revision (at least once every five years), a standard or recomme
17、nded 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
18、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. While observed or potential risks with existing equipment typically form the basis for the
19、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 product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate de
20、cision 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 rati
21、onale 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
22、 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 the Manager for Technical Development. An official interpretation must be approved by let
23、ter 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 interpre- tation in the “Standards Monitor“
24、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 published,
25、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/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:37 MDTNo reproduction or networkin
26、g permitted without license from IHS -,-,- American National Standard ANSI/AAMI RD52:2004 Dialysate for hemodialysis Developed by Association for the Advancement of Medical Instrumentation Approved 9 August 2004 by American National Standards Institute, Inc. Abstract: This recommended practice cover
27、s the appropriate preparation of dialysate, handling of concentrates, operation of water treatment equipment and handling of its product water, monitoring of systems and the dialysate produced, and risks and hazards of dialysate preparation failure. Keywords: dialysate, dialyzing fluid Copyright Ass
28、ociation for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:37 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Recommended Practice This Associatio
29、n for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI recommended practice does not in any respect preclude anyone, whether they have approved the recommended practice
30、or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the recommended practice. AAMI recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice
31、may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this recommended practice no later than five years from the date of publication. Interested parties may obtain current information on all AAMI documents by calling or writing AAMI.
32、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 judgment of the user of the document. Occasionally, voluntary technical documents a
33、re 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 Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2004
34、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 without the prior written permission of the Association for the Advancement of Med
35、ical 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 written permission of the Association for the Advancement of Medical Instrumentation. V
36、iolators 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 at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed
37、in the United States of America ISBN 1570202230 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:37 MDTNo reproduction or networking permitted without lic
38、ense from IHS -,-,- Contents Page Glossary of equivalent standards.v Committee representationvii Foreword. viii Introduction: Need for this AAMI recommended practiceix 1 Scope1 1.1 General 1 1.2 Inclusions.1 1.3 Exclusions1 2 Normative references1 3 Definitions.2 4 Fluid quality.5 4.1 Water .5 4.1.1
39、 Maximum level of chemical contaminants in water 5 4.1.2 Bacteriology of water .6 4.2 Concentrate7 4.2.1 Maximum level of chemical contaminants in concentrate 7 4.2.2 Bacteriology of concentrate7 4.3 Dialysate 7 4.3.1 Maximum level of chemical contaminants in dialysate.7 4.3.2 Bacteriology of dialys
40、ate7 5 Equipment.8 5.1 General 8 5.2 Water purification systems.8 5.2.1 General8 5.2.2 Sediment filters8 5.2.3 Cartridge filters 8 5.2.4 Softeners .9 5.2.5 Carbon adsorption .9 5.2.6 Chemical injection systems10 5.2.7 Reverse osmosis .10 5.2.8 Deionization.10 5.2.9 Ultrafiltration.11 5.3 Water stora
41、ge and distribution .11 5.3.1 General11 5.3.2 Water storage 11 5.3.3 Water distribution systems.12 5.3.4 Bacterial control devices12 5.4 Concentrate preparation.13 5.4.1 General13 5.4.2 Materials compatibility14 5.4.3 Bulk storage tanks (acid concentrate)14 5.4.4 Mixing systems 14 5.4.5 Additives15
42、5.5 Concentrate distribution .15 5.5.1 Materials compatibility15 5.5.2 System configurations16 5.5.3 Acid concentrate distribution systems16 5.5.4 Bicarbonate concentrate distribution systems16 5.5.5 Concentrate outlets16 5.6 Dialysate proportioning.17 Copyright Association for the Advancement of Me
43、dical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:48:37 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 Monitoring.18 6.1 General 18 6.2 Water purification.19 6.2.1 General19 6.
44、2.2 Sediment filters20 6.2.3 Cartridge filters 20 6.2.4 Softeners .20 6.2.5 Carbon adsorption .20 6.2.6 Chemical injection systems21 6.2.7 Reverse osmosis .21 6.2.8 Deionization.21 6.2.9 Ultrafiltration.22 6.3 Water storage and distribution .22 6.3.1 General22 6.3.2 Water storage 22 6.3.3 Water dist
45、ribution systems.22 6.3.4 Bacterial control devices22 6.4 Concentrate preparation.23 6.4.1 Mixing systems 23 6.4.2 Additives23 6.5 Concentrate distribution .23 6.6 Dialysate proportioning.23 7 Strategies for bacterial control 24 7.1 General 24 7.2 Microbial monitoring methods 25 7.2.1 General25 7.2.
46、2 Sample collection.27 7.2.3 Heterotrophic plate count.27 7.2.4 Bacterial endotoxin test27 8 Environment28 9 Personnel28 Annexes A Rationale for the development and provisions of this recommended practice.29 B Bibliography 39 Tables 1 Maximum allowable chemical contaminant levels in water used to pr
47、epare dialysate and concentrates from powder at a dialysis facility and to reprocess dialyzers for multiple uses.6 2 Compatibility of common disinfectants with piping materials used in water distribution systems .12 3 Symbols and color coding for different concentrate proportioning ratios.17 4 Monit
48、oring guidelines for water purification equipment and distribution systems and dialysate .18 A.1 Lowest level of endotoxin detectable using assays of different sensitivity and with different sample dilutions of bicarbonate concentrate.37 A.2 Maximum allowable sample dilution for detection of endotox
49、in concentrations of 1 EU/mL and 2 EU/mL as a function of assay sensitivity38 Figures 1 Example of decision tree that can be used to evaluate culture results and initiate corrective action, if necessary.26 2 Example of a component label for a regenerable softener28 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license wit