1、ANSI/AAMI 11663:2014Quality of dialysis fluid for hemodialysis and related therapiesAmerican National StandardAmerican National Standard ANSI/AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies Approved 21 July 2014 by Association for the Advancement of Medical Instrumen
2、tation Approved 8 August 2014 by American National Standards Institute, Inc. Abstract: Specifies minimum quality requirements for dialysis fluids used in hemodialysis and related therapies. Includes dialysis fluids used for hemodialysis and hemodiafiltration, including substitution fluid for hemodia
3、filtration and hemofiltration. Keywords: action, chemical, contaminant, endotoxin, microbiological, compliance 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
4、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
5、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 CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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
6、ation 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 by AAMI are voluntary, and their application is solely within the discre
7、tion 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 enforcement of its rules and regulations. Published by Association fo
8、r the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwis
9、e, 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 any part of this document (whether internally
10、 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 use of all or any part of this document, comp
11、lete the reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-547-7 Contents PageGlossary of equivalent standards . ivCommittee representation .
12、v US deviation to ISO 11663:2014 vi Introduction vii 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements . 6 4.1 Microbiological contaminants in dialysis fluid . 6 4.2 Chemical contaminants in dialysis fluid 7 5 Tests for compliance with microbiological requirements 7 Annex A
13、 (informative) Rationale for the development and provisions of this International Standard . 9 Annex B (informative) Reference tables from ISO 13959 12 Bibliography . 16 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other In
14、ternational Standards. AAMI maintains a current list of each International 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/st
15、andards/glossary.pdf iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 11663:2014 Committee representation Association for the Advancement of Medical Instrumentation AAMI Renal Disease and Detoxification Committee This American National Standard was developed by the AAMI R
16、enal Disease and Detoxification Committee. Approval of the American National Standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Renal Disease and Detoxification Committee had the following members: Chairs: Conor Cu
17、rtin David Roer, MD, FACP, FASN, FASH Members: G Steven Acres, MD, Carolina Regional Nephrology Associates James Weldon Baker, AmeriWater Alex Barten, Baxter Healthcare Corporation Christian Gert Bluchel, AWAK Technologies Pte Ltd. Karla S. Byrne, Rockwell Medical Inc Danilo B. Concepcion, CBNT, CCH
18、T-A, St Joseph Hospital Renal Center Deborah A. Cote, MSN ,RN, CNN, National Renal Administrators Association Conor Curtin, Fresenius Medical Care North America Jim Curtis, Portland, OR R. Barry Deeter, RN MSN, University of Utah Dialysis Program Martin T. Gerber, Medtronic Inc. Gema Gonzalez, FDA/C
19、DRH/ODE Elizabeth Howard, DaVita, Inc. Byron L. Jacobs, CBET, Sanford USD Medical Center Judith Kari, Health Care Financing Administration Kendall Larson, Mar Cor Purification Nathan W. Levin, MD, Renal Research Institute LLC Jo Ann Maltais, PhD, Maltais Consulting Duane Martz, B Braun of America, I
20、nc. Lane McCarthy, CCHT, Hortense or 2) Trypticase soy agar (TSA, a soybean casein digest agar) or standards method agar and plate count agar (also known as TGYE), incubated at 35 C for 48 hours. Other test methods may also be used, provided such methods have been appropriately validated and compare
21、d to the cited methods. See USP for guidance on adoption of alternative methods.” The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. T
22、o remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. vi
23、2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 11663:2014 Introduction Hemodialysis patients are directly exposed to large volumes of dialysis fluid, with the dialyzer membrane being the only barrier against transfer of hazardous contaminants from the dialysis fluid to the
24、 patient. It has long been known that there could be hazardous contaminants in the water and concentrates used to prepare the dialysis fluid. To minimize this hazard, ISO 13958 and ISO 13959 set forth quality requirements for the water and concentrates used to prepare dialysis fluid. However, if the
25、 dialysis fluid is not prepared carefully, it could contain unacceptable levels of contaminants even though it is prepared from water and concentrates, meeting the requirements of ISO 13958 and ISO 13959. Further, the dialysis fluid might be used as the starting material for the online preparation o
26、f fluids intended for infusion into the patient, for example, in therapies such as online hemodiafiltration. For these reasons, this International Standard for dialysis fluid quality was developed to complement the existing International Standards for water and concentrates, ISO 13959 and ISO 13958,
27、 respectively. Guidelines to aid the user in routinely meeting the requirements of this International Standard and ISO 13959 can be found in ISO 23500. Within these International Standards, measurement techniques current at the time of preparation have been cited. Other standard methods can be used,
28、 provided that such methods have been appropriately validated and compared to the cited methods. This International Standard reflects the conscientious efforts of healthcare professionals, patients, and medical device manufacturers to develop recommendations for the quality of dialysis fluid. This I
29、nternational Standard is directed at the healthcare professionals involved in the management of dialysis facilities and the routine care of patients treated in dialysis facilities, since they are responsible for the final preparation of dialysis fluid. The recommendations contained in this Internati
30、onal Standard are not intended for regulatory application. The requirements of this International Standard aim to help protect hemodialysis patients from adverse effects arising from known chemical and microbiological contaminants that can be found in improperly prepared dialysis fluid. However, the
31、 physician in charge of dialysis has the ultimate responsibility for ensuring that the dialysis fluid is correctly formulated and meets the requirements of all applicable quality standards. The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC Dire
32、ctives, Part 2. For the purposes of this International Standard, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compliance with this International Standard, “should” means that compliance with a requirement or a test is recommended but is not mandatory
33、 for compliance with this International Standard, and “may” is used to describe a permissible way to achieve compliance with a requirement or test. The concepts incorporated in this International Standard should not be considered inflexible or static. The recommendations presented here should be rev
34、iewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 11663:2014 vii viii 2014 Association for the Advancement of Medical Ins
35、trumentation ANSI/AAMI 11663:2014 American National Standard ANSI/AAMI 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies 1 Scope This International Standard specifies minimum quality requirements for dialysis fluids used in hemodialysis and related therapies. This Internati
36、onal Standard includes dialysis fluids used for hemodialysis and hemodiafiltration, including substitution fluid for hemodiafiltration and hemofiltration. This International Standard does not address the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used
37、 in its preparation. Those areas are covered by other International Standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use prepackaged solutions, and systems and solutions
38、 for peritoneal dialysis are excluded from this International Standard. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated refere
39、nces, the latest edition of the referenced document (including any amendments) applies. ISO 13958, Concentrates for hemodialysis and related therapies ISO 13959, Quality of water for hemodialysis and related therapies 3 Terms and definitions For the purposes of this document, the following terms and
40、 definitions apply. 3.1 acid concentrate A-concentrate acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate concentrate, yields dialysis fluid for use in dialysis Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid o
41、r citric acid) that is included in the concentrate. Note 2 to entry: Acid concentrate may contain glucose. Note 3 to entry: Acid concentrate may be in the form of a liquid, a dry powder, other highly concentrated media, or some combination of these forms. 2014 Association for the Advancement of Medi
42、cal Instrumentation ANSI/AAMI 11663:2014 1 3.2 action level concentration of a contaminant at which steps should be taken to interrupt the trend toward higher, unacceptable levels 3.3 bicarbonate concentrate B-concentrate concentrated preparation of sodium bicarbonate that, when diluted with dialysi
43、s water and acid concentrate, makes dialysis fluid used for dialysis Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate. Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride. Note 3 to entry: Bicarbonate concentrate can be in the form of a liquid or
44、 a dry powder. Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators to produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid. 3.4 central dialysis fluid delivery system system that produces
45、dialysis fluid from dialysis water and concentrate or powder at a central point and distributes the dialysis fluid from the central point to individual dialysis machines 3.5 chlorine, combined chlorine that is chemically combined, such as in chloramine compounds Note 1 to entry: There is no direct t
46、est for measuring combined chlorine, but it may be measured indirectly by measuring both total and free chlorine and calculating the difference. 3.6 chlorine, free chlorine present in water as dissolved molecular chlorine (Cl2), hypochlorous acid (HOCI), and hypochlorite ion (OCl) Note 1 to entry: T
47、he three forms of free chlorine exist in equilibrium. 3.7 chlorine, total sum of free and combined chlorine Note 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid and/or hypochlorite ion (free chlorine), or in chemically combined forms (combined chlorine). Wh
48、ere chloramine is used to disinfect water supplies, chloramine is usually the principal component of combined chlorine. 3.8 colony-forming unit CFU measure of bacterial or fungal cell numbers that theoretically arise from a single cell when grown on solid media Note 1 to entry: Colonies can also for
49、m from groups of organisms when they occur in aggregates. 2 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 11663:2014 3.9 concentrate generator system where the concentrate is delivered to the user as a powder in a container, suitable for attachment to the dialysis machine with which it is intended to be used, and then the powder is converted into a concentrated solution by the dialysis machine Note 1 to entry: The solution produced by the concentrate generator is used by the dialysis machine to make the final dialysis fluid deli
