ANSI AAMI 26722-2014 Water treatment equipment for hemodialysis and related therapies.pdf

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1、ANSI/AAMI 26722:2014Water treatment equipment for hemodialysis and related therapiesAmerican National StandardAmerican National Standard ANSI/AAMI 26722:2014 Water treatment equipment 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: Covers devices used to treat water intended for use in the delivery of hemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated med

3、ia at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of dialyzers for multiple uses. Included within the scope are all devices, piping and fittings between the point at which potabl

4、e water is delivered to the water treatment system, and the point of use of the dialysis water. Addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for hemodialysis or related therapies. Keywords: action, acid, biofi

5、lm, chlorine, compliance, endotoxin, labeling, 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 standard does not in any respect preclude

6、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 the latest editions. CAUTION NOTICE: This AA

7、MI standard may be revised or withdrawn at any time.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 AAMI standards by calling or writing AAMI,

8、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 professional judgment of the user of the docume

9、nt. 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 Advancement of Medical Instrumentation 4301 N. Fai

10、rfax 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 any part of this document without the prior

11、 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 externally) without the prior written permission of

12、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 reprint request form at www.aami.org or contact

13、 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 1-57020-551-5 Contents Page Glossary of equivalent standards ivCommittee representation . v US deviation to ISO 26722:2014 . vi Introduction vii 1 Scope

14、 1 2 Normative references 1 3 Terms and definitions 2 4 Requirements . 7 4.1 Dialysis water quality requirements . 7 4.2 Water treatment equipment requirements . 8 5 Tests . 14 5.1 Compliance with dialysis water quality requirements 14 5.2 Compliance with water treatment equipment requirements 15 6

15、Labelling . 18 6.1 General . 18 6.2 Device markings 18 6.3 Product literature . 19 Annex A (informative) Rationale for the development and provisions of this International Standard . 21 Annex B (informative) Reference tables from ISO 13959 31 Bibliography . 35 Glossary of equivalent standards Intern

16、ational Standards adopted in the United States may include normative 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 correspondi

17、ng U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 26722:2014 Committee representation Association for the Advancement of Medical Instrumentation AAMI Renal Disea

18、se and Detoxification Committee This American National Standard 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

19、AAMI Renal Disease and Detoxification Committee had the following members: Chairs: 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

20、 Technologies Pte Ltd. Karla S. Byrne, Rockwell Medical Inc 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

21、, University of Utah Dialysis Program Martin T. Gerber, Medtronic 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 Resear

22、ch Institute LLC Jo Ann Maltais, PhD, Maltais Consulting Duane Martz, B Braun of America, Inc. 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 me

23、thods may also be used, provided such methods have been appropriately validated and compared to the cited methods. See USP for guidance on adoption of alternative methods. Endotoxin concentrations shall be determined by the LAL assay or kinetic method validated to yield results that are equivalent t

24、o LAL.” 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. To remain relevant, it must be modified as technological advances are made

25、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 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI

26、26722:2014 Introduction This International Standard reflects the conscientious efforts of concerned physicians, clinical engineers, nurses, dialysis technicians, and dialysis patients, in consultation with device manufacturers and government representatives, to develop an International Standard for

27、performance levels that could be reasonably achieved at the time of publication. The term “consensus,” as applied to the development of voluntary medical device International Standards, does not imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a variety

28、 of interests should be merged. The provisions of this International Standard apply to individual water treatment devices and to water treatment systems assembled from one or more of these devices. In the first instance, this International Standard is directed at the individual or company that speci

29、fies the complete water treatment system and, second, at the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this International Standard are also directed at the manufacturers of these devices, prov

30、ided that the manufacturer indicates that the device is intended for use in hemodialysis applications. This International Standard is written principally to address water treatment systems for dialysis facilities treating multiple patients. However, many of its provisions equally apply to water trea

31、tment systems used in applications where a single patient is treated, such as in a home dialysis or acute hospital dialysis setting. Specifically, requirements for the chemical and microbiological quality of water are considered to apply in all settings, regardless of whether a single patient or man

32、y patients are being treated. The verbal forms 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

33、compliance with this International Standard, “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. The requirem

34、ents established by this International Standard should help protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminants found in water supplies. However, proper dialysis and patient safety is ultimately dependent on the quality of the dialysis fluid. Sin

35、ce the manufacturer or supplier of water treatment equipment does not have control over the dialysis fluid, any reference to dialysis fluid in this International Standard is for clarification only and not a requirement of the manufacturer. The responsibility for assuring that the dialysis fluid is n

36、ot contaminated, mismatched, or otherwise damaging to the patient rests with the clinical professionals caring for the patient under the supervision of the medical director. Recommendations on the preparation and handling of water and dialysis fluid in a dialysis facility are provided in ISO 23500.

37、2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 26722:2014 vii viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 26722:2014 American National Standard ANSI/AAMI 26722:2014Water treatment equipment for hemodialysis applications and related therap

38、ies 1 Scope 1.1 General This International Standard is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for hemodialysis or related therapies. 1.2 Inclusions This International Standard covers devices used to trea

39、t water intended for use in the delivery of hemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for th

40、e preparation of substitution fluid; (3) the reprocessing of dialyzers for multiple uses. Included within the scope of this International Standard are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dia

41、lysis water. Examples of devices included within the scope of this International Standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water. 1.3 Exclusions Excluded from the scope of this Internati

42、onal Standard are dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, hemodiafiltration systems, hemofiltration systems,

43、 systems that process dialyzers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other International Standards. Also excluded from the scope of this International Standard are requirements for the on

44、going monitoring of the purity of water used for dialysis fluid, concentrate preparation, or dialyzer reprocessing. 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 t

45、he edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 13959:2014, Water for hemodialysis and related therapies ISO 14971:2007, Medical devices Application of risk management to medical devices IEC 60601-1-8, Medical el

46、ectrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 2014 Association for the Advancement of Medical Instrumentation

47、ANSI/AAMI 26722:2014 1 3 Terms and definitions For the purposes of this document, the following terms and 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

48、 dialysis Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is included in the concentrate. Note 2 to entry: Acid concentrate can contain glucose. Note 3 to entry: Acid concentrate can be in the form of a liquid, a dry powder, other hi

49、ghly concentrated media, or some combination of these forms. 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 dialysis 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: Bic