ANSI AAMI 13959-2014 Water for hemodialysis and related therapies.pdf

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1、ANSI/AAMI 13959:2014Water for hemodialysis and related therapiesAmerican National StandardAmerican National Standard ANSI/AAMI 13959:2014 Water for hemodialysis and related therapies Approved 21 July 2014 by Association for the Advancement of Medical Instrumentation Approved 15 August 2014 by Americ

2、an National Standards Institute, Inc. Abstract: Specifies minimum requirements for water to be used in hemodialysis and related therapies. Includes water to be used in the preparation of concentrates, dialysis fluids for hemodialysis, hemodiafiltration and hemofiltration, and for the reprocessing of

3、 hemodialyzers Keywords: chemical, compliance, colony, endotoxin, fluid, microbiological, pyrogen 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 existence of an AAMI

4、 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 cautioned to obtain t

5、he 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 CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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 information on all

6、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 discretion and prof

7、essional 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 for the Advance

8、ment 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 otherwise, of all or

9、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 or externall

10、y) 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, complete the repr

11、int 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 1-57020-549-3 Contents Page Glossary of equivalent standards iv Committee representation . v US deviatio

12、n to ISO 13959:2014 . vi Introduction vii 1 Scope 1 2 Terms and definitions 1 3 Dialysis water requirements . 5 3.1 Dialysis water verification and monitoring 5 3.2 Microbiological requirements . 5 3.3 Chemical contaminants . 6 4 Tests for compliance with microbiological and chemical requirements 7

13、4.1 Microbiology of dialysis water 7 4.2 Chemical contaminants test methods . 8 Annex A (informative) Rationale for the development and provisions of this International Standard . 11 Bibliography . 15 Glossary of equivalent standards International Standards adopted in the United States may include n

14、ormative references to other International 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 Internat

15、ional Standard. www.aami.org/standards/glossary.pdf iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 Committee representation Association for the Advancement of Medical Instrumentation AAMI Renal Disease and Detoxification Committee This American National Stand

16、ard was developed by the AAMI Renal 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 foll

17、owing members: Cochairs: Conor Curtin 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 In

18、c Danilo B. Concepcion, CBNT, CCHT-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, Me

19、dtronic Inc. Gema Gonzalez, FDA/CDRH/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 D

20、uane Martz, B Braun of America, Inc. Lane McCarthy, CCHT, Hortense or2) 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 appro

21、priately validated and compared to the cited methods. See USP for guidance on adoption of alternative methods. No method will give a total microbial count.” The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and u

22、pdated periodically to assimilate progressive technological developments. To 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 Depart

23、ment, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. vi 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 Introduction Assurance of adequate water quality is one of the most important aspects of ensuring a safe and effective delivery of hemodialy

24、sis, hemodiafiltration, or hemofiltration. This International Standard contains minimum requirements, chemical and microbiological, for the water to be used for preparation of dialysis fluids, concentrates, and for the reprocessing of hemodialyzers and the necessary steps to ensure compliance with t

25、hose requirements. Hemodialysis and hemodiafiltration can expose the patient to more than 500 l of water per week across the semi-permeable membrane of the hemodialyzer or hemodiafilter. Healthy individuals seldom have a weekly oral intake above 12 l. This over 40-fold increase in exposure requires

26、control and monitoring of water quality to avoid excesses of known or suspected harmful substances. Since knowledge of potential injury from trace elements and contaminants of microbiological origin over long periods is still growing and techniques for treating drinking water are continuously develo

27、ped, this International Standard will evolve and be refined accordingly. The physiological effects attributable to the presence of organic contaminants in dialysis water are important areas for research. At the time this International Standard was published it was not possible to specify threshold v

28、alues for organic contaminants permitted in water used for the preparation of dialysis fluids, concentrates, and reprocessing of hemodialyzers. The issue of organic contaminants will be reassessed on the next revision of this International Standard. Within this International Standard, measurement te

29、chniques current at the time of publication have been cited. Other standard methods may be used, provided that such methods have been appropriately validated and compared to the cited methods. The final dialysis fluid is produced from concentrates or salts manufactured, packaged, and labelled accord

30、ing to ISO 13958 mixed with water meeting the requirements of this International Standard. Operation of water treatment equipment and hemodialysis systems, including ongoing monitoring of the quality of water used to prepare dialysis fluids, and handling of concentrates and salts are the responsibil

31、ity of the hemodialysis facility and are addressed in ISO 23500. Hemodialysis professionals make choices about the various applications (hemodialysis, hemodiafiltration, hemofiltration) and should understand the risks of each and the requirements for safety for fluids used for each. The verbal forms

32、 used in this International Standard conform to usage described in Annex H of the ISO/IEC Directives, 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, “

33、should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this International Standard, and “may” is used to describe a permissible way to achieve compliance with a requirement or test. This International Standard is directed towards manufactur

34、ers and providers of water treatment systems and also to hemodialysis facilities. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 vii viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 American National Standard ANSI/AAMI 13

35、959:2014Water for hemodialysis and related therapies 1 Scope This International Standard specifies minimum requirements for water to be used in hemodialysis and related therapies. This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for hemodialys

36、is, hemodiafiltration and hemofiltration, and for the reprocessing of hemodialyzers. The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibilit

37、y of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 action level concentration of a contaminant at which steps should be taken to inte

38、rrupt the trend toward higher, unacceptable levels 2.2 chlorine, combined chlorine that is chemically combined, such as in chloramine compounds Note 1 to entry: There is no direct test for measuring combined chlorine, but it can be measured indirectly by measuring both total and free chlorine and ca

39、lculating the difference. 2.3 chlorine, free chlorine present in water as dissolved molecular chlorine (Cl2), hypochlorous acid (HOCl), and hypochlorite ion (OCl) Note 1 to entry: The three forms of free chlorine exist in equilibrium. 2.4 chlorine, total sum of free and combined chlorine Note 1 to e

40、ntry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid, and/or hypochlorite ion (free chlorine) or in chemically combined forms (combined chlorine). Where chloramine is used to disinfect water supplies, chloramine is usually the principal component of combined chlorine.

41、 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 1 2.5 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 form from groups of organisms when

42、they occur in aggregates. 2.6 device individual water purification unit, such as a softener, carbon bed, reverse osmosis unit, or deionizer Note 1 to entry: This term is synonymous with the term “component” as used by the US Food and Drug Administration (see Reference 49). 2.7 dialysis fluid dialysa

43、te dialysis solution aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange solutes with blood during hemodialysis Note 1 to entry: The term “dialysis fluid” is used throughout this International Standard to mean the fluid made from dialysis water and c

44、oncentrates that is delivered to the dialyzer by the dialysis fluid delivery system. Such phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that usage is discouraged to avoid confusion. Note 2 to entry: The dialysis fluid entering the dialy

45、zer is referred to as “fresh dialysis fluid”, while the fluid leaving the dialyzer is referred to as “spent dialysis fluid.” Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement therapies, such as hemodiafiltration and hemofiltration. 2.8 dial

46、ysis fluid delivery system device that prepares dialysis fluid online from dialysis water and concentrates or that stores and distributes premixed dialysis fluid, circulates the dialysis fluid through the dialyzer, monitors the dialysis fluid for temperature, conductivity (or equivalent), pressure,

47、flow and blood leaks, and prevents dialysis during disinfection or cleaning modes Note 1 to entry: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid, and monitors and associated alarms and controls assembled as a system for the purposes listed above. Note 2 to entr

48、y: The dialysis fluid delivery system can be an integral part of the single-patient dialysis machine or a centralized preparation system which feeds multiple bedside monitoring systems. Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply

49、 systems. 2.9 dialysis water water that has been treated to meet the requirements of this International Standard and which is suitable for use in hemodialysis applications, including the preparation of dialysis fluid, reprocessing of dialyzers, preparation of concentrates, and preparation of substitution fluid for online convective therapies 2 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13959:2014 2.10 disinfection destruction of pathogenic and other kinds of microorganisms by thermal or chemical means Note 1 to entry: Disinfe