1、ANSI/AAMI 13958:2014Concentrates for hemodialysis and related therapiesAmerican National StandardAmerican National Standard ANSI/AAMI 13958:2014 Concentrates for hemodialysis and related therapies Approved 21 July 2014 by Association for the Advancement of Medical Instrumentation Approved 15 August
2、2014 by American National Standards Institute, Inc. Abstract: Specifies minimum requirements for concentrates used for hemodialysis and related therapies. Addressed to the manufacturer of concentrates. Includes concentrates in both liquid and powder forms. Also included are additives, also called sp
3、ikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. Gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the users facility.
4、Keywords: action, acid, bicarbonate, biofilm, fluid, endotoxin, pyrogen, sterileAAMI 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
5、 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 the latest editions
6、. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time.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 AAMI standards by
7、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 professional judgment
8、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 Advancement of Medical In
9、strumentation 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 any part of this d
10、ocument 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 externally) without the pri
11、or 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 reprint request form a
12、t 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 1-57020-548-5 Contents Page Glossary of equivalent standards iv Committee representation . v US deviation to ISO 13958:201
13、4 . vi Introduction vii 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Requirements . 7 4.1 Concentrates 7 4.2 Manufacturing equipment . 10 4.3 Systems for mixing concentrate at a dialysis facility . 10 5 Tests . 12 5.1 General . 12 5.2 Concentrates 12 5.3 Manufacturing equipment . 1
14、4 5.4 Systems for mixing concentrate at a dialysis facility . 15 6 Labelling . 16 6.1 General . 16 6.2 General labelling requirements for concentrates . 16 6.3 Labelling requirements for liquid concentrate 17 6.4 Labelling requirements for powder concentrate . 18 6.5 Additives . 18 6.6 Labelling req
15、uirements for concentrate generators . 18 6.7 Labelling for concentrate mixer systems 19 Annex A (informative) Rationale for the development and provisions of this International Standard . 21 Bibliography . 27 Glossary of equivalent standards International Standards adopted in the United States may
16、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 corresponding U.S. designation and level of equivalency to the
17、 International Standard. www.aami.org/standards/glossary.pdf iv 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13958:2014 Committee representation Association for the Advancement of Medical Instrumentation AAMI Renal Disease and Detoxification Committee This American Natio
18、nal 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 AAMI Renal Disease and Detoxification Committee had
19、 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 Technologies Pte Ltd. Karla S. Byrne, Rockwell Med
20、ical 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, University of Utah Dialysis Program Martin T. Ger
21、ber, 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 Research Institute LLC Jo Ann Maltais, PhD, Maltais Consu
22、lting 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 methods may also be used, provided such methods have
23、been appropriately validated and compared 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 p
24、rogressive 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 Department, AAMI, 4301 N. Fairfax Drive,
25、Suite 301, Arlington, VA 22203-1633. vi 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13958:2014 Introduction The requirements and goals established by this American National Standard will help ensure the effective, safe performance of hemodialysis concentrates and relate
26、d materials. This American National 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 a standard for performance levels that
27、 could be reasonably achieved at the time of publication. The term “consensus” as applied to the development of voluntary medical device standards does not imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a variety of interests must be merged. Throughou
28、t this American National Standard, recommendations are made to use ISO-quality water. Therefore, it is recommended to review ISO 13959 along with this American National Standard. This American National Standard does not cover the dialysis fluid that is used to clinically dialyze patients. Dialysis f
29、luid is covered in ISO 11663. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the users responsibil
30、ity to ensure proper use. In addition, this American National Standard does not cover hemodialysis equipment, which is addressed in the new edition of IEC 60601-2-16. The verbal forms used in this American National Standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For
31、 the purposes of this American National 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 for compliance
32、 with this International Standard, and “may” is used to describe a permissible way to achieve compliance with a requirement or test. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13958:2014 vii viii 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI
33、 13958:2014 American National Standard ANSI/AAMI 13958:2014Concentrates for hemodialysis and related therapies 1 Scope This International Standard specifies minimum requirements for concentrates used for hemodialysis and related therapies. For the purpose of this International Standard, “concentrate
34、s” are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform hemodialysis and related therapies. This International Standard is addressed to the manufacturer of such conce
35、ntrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis f
36、luid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. This International Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to inc
37、rease the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the users facility. Concentrates prepared from prepackag
38、ed salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of thi
39、s International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in ISO 23500. Thi
40、s International Standard does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid. 2 Normative references The following documents, in whole or in part, are normatively referenced in this documen
41、t and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11663, Quality of dialysis fluid for hemodialysis and related therapies ISO 13959:2014, Wat
42、er for hemodialysis and related therapies ISO 14971, Medical devices Application of risk management to medical devices IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 61010-1, Safety requirements for electrical equipment for measu
43、rement, control, and laboratory use Part 1: General requirements 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13958:2014 1 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 acetate concentrate concentrated solution
44、of salts containing acetate, which, when diluted with dialysis water, yields bicarbonate-free dialysis fluid for use in dialysis Note 1 to entry: Acetate concentrate may contain glucose. Note 2 to entry: Sodium acetate is used to provide a buffer in place of sodium bicarbonate. Note 3 to entry: Acet
45、ate concentrate is used as a single concentrate. 3.2 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 aci
46、d (for example, acetic acid or 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. 3.3 action leve
47、l concentration of a contaminant at which steps should be taken to interrupt the trend toward higher, unacceptable levels 3.4 additive spike small amount of a single chemical that, when added to the concentrate, will increase the concentration of a single existing chemical by a value labelled on the
48、 additive packaging 3.5 batch system apparatus in which the dialysis fluid is prepared in bulk before each dialysis session 3.6 bicarbonate concentrate B-concentrate concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid concentrate, makes dialysis fluid used
49、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 may be in the form of a liquid or a dry powder. 2 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI 13958:2014 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 dial
