CAN CSA-ISO 13959-2015 Water for haemodialysis and related therapies (Second Edition).pdf

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1、 ISO 2014. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 13959:15(ISO 13959:2014, IDT)National Standard of CanadaCAN/CSA-ISO 13959:15Water for haemodialysis and related therapies(ISO 13959:2014, IDT)Legal Notice for StandardsCanadian Standards Asso

2、ciation (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensusand develop a standard. Although CSA Group admi

3、nisters the process and establishes rules to promote fairness in achieving consensus, it doesnot independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express

4、 or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringementof any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or curre

5、ncy of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicablestatute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEE

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10、 Group has no power, nor does itundertake, to enforce compliance with the contents of the standards or other documents it publishes.Intellectual property rights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or

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12、 applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document mayviolate laws that protect CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legalredress for such use, modificati

13、on, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectualproperty rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not beheld

14、responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity ofany such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA Group for informational and n

15、on-commercial use only. The user of this document is authorized to doonly the following:If this document is in electronic form: load this document onto a computer for the sole purpose of reviewing it; search and browse this document; and print this document if it is in PDF format.Limited copies of t

16、his document in print or paper form may be distributed only to persons who are authorized by CSA Group to have suchcopies, and only if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to alter this document in any way or remove this Legal Notice from t

17、he attached standard; sell this document without authorization from CSA Group; or make an electronic copy of this document.If you do not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make anycopies of the contents hereof, and if y

18、ou do make such copies, you are required to destroy them immediately. Use of this documentconstitutes your acceptance of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-ISO 13959:15November 2015Title: Water for haemodialysis and related therapiesTo register for e-mail n

19、otification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2424311.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privac

20、y at www.csagroup.org/legal to find out how we protect yourpersonal information.Canadian Standards Association (operating as “CSA Group”), underwhose auspices this National Standard has been produced, waschartered in 1919 and accredited by the Standards Council ofCanada to the National Standards sys

21、tem in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged instandards development and certification activities.CSA Group standards reflect a national consensus of producers andusers including manufacturers, consumers, retailers, unions andprofessional organizations,

22、 and governmental agencies. Thestandards are used widely by industry and commerce and oftenadopted by municipal, provincial, and federal governments in theirregulations, particularly in the fields of health, safety, building andconstruction, and the environment.Individuals, companies, and associatio

23、ns across Canada indicatetheir support for CSA Groups standards development byvolunteering their time and skills to Committee work and supportingCSA Groups objectives through sustaining memberships. The morethan 7000 committee volunteers and the 2000 sustainingmemberships together form CSA Groups to

24、tal membership fromwhich its Directors are chosen. Sustaining memberships represent amajor source of income for CSA Groups standards developmentactivities.CSA Group offers certification and testing services in support of andas an extension to its standards development activities. To ensurethe integr

25、ity of its certification process, CSA Group regularly andcontinually audits and inspects products that bear theCSA Group Mark.In addition to its head office and laboratory complex in Toronto, CSAGroup has regional branch offices in major centres across Canadaand inspection and testing agencies in ei

26、ght countries. Since 1919,CSA Group has developed the necessary expertise to meet itscorporate mission: CSA Group is an independent serviceorganization whose mission is to provide an open and effectiveforum for activities facilitating the exchange of goods and servicesthrough the use of standards, c

27、ertification and related services tomeet national and international needs.For further information on CSA Group services, write toCSA Group178 Rexdale Boulevard,Toronto, Ontario, M9W 1R3CanadaA National Standard of Canada is a standard developed by an SCC-accredited Standards Development Organization

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29、an be foundat www.scc.ca.An SCC-approved standard reflects the consensus of a number ofexperts whose collective interests provide, to the greatestpracticable extent, a balance of representation of affectedstakeholders. National Standards of Canada are intended to make asignificant and timely contrib

30、ution to the Canadian interest.SCC is a Crown corporation within the portfolio of Industry Canada.With the goal of enhancing Canadas economic competitiveness andsocial well-being, SCC leads and facilitates the development and useof national and international standards. SCC also coordinatesCanadian p

31、articipation in standards development, and identifiesstrategies to advance Canadian standardization efforts.Accreditation services are provided by SCC to various customers,including product certifiers, testing laboratories, and standardsdevelopment organizations. A list of SCC programs and accredite

32、dbodies is publicly available at www.scc.ca.Users should always obtain the latest edition of a National Standardof Canada from the standards development organization responsiblefor its publication, as these documents are subject to periodicreview.Standards Council of Canada600-55 Metcalfe StreetOtta

33、wa, Ontario, K1P 6L5CanadaCette Norme Nationale du Canada nest disponible quen anglais. Le Groupe CSA publiera la version en franais ds quelle sera produite parlorganisme rdacteur.Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remai

34、ns the responsibility ofthe users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”ICS 11.040.40ISBN 978-1-4883-0270-1 2015 CSA GroupAll rights reserved. No part of this publication may be reproduced in any form whats

35、oeverwithout the prior permission of the publisher.Published in November 2015 by CSA GroupA not-for-profit private sector organization178 Rexdale Boulevard,Toronto, Ontario, Canada M9W 1R3To purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463

36、-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byWater for haemodialysis and relatedtherapies(ISO 13959:2014, IDT)CAN/CSA-ISO 13959:15National Standard of CanadaCAN/CSA-

37、ISO 13959:15 Water for haemodialysis and related therapiesNovember 2015 2015 CSA GroupCSA/5CAN/CSA-ISO 13959:15Water for haemodialysis and relatedtherapies(ISO 13959:2014, IDT)CSA PrefaceThis is the second edition of CAN/CSA-ISO 13959, Water for haemodialysis and related therapies, whichis an adopti

38、on without modification of the identically titled ISO (International Organization forStandardization) Standard 13959 (third edition, 2014-04-01). It supersedes the previous editionpublished in 2011 as CAN/CSA-ISO 13959 (adopted ISO 13959:2009). At the time of publication, ISO13959:2014 is available

39、from ISO in English only. CSA Group will publish the French version when itbecomes available from ISO.For brevity, this Standard will be referred to as “CAN/CSA-ISO 13959” throughout.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Kidney Dialysisunder the jurisdict

40、ion of the CSA Strategic Steering Committee on Health Care Technology b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committee on KidneyDialysisJ. Maahs Baxter-Gambro Renal,Richmond Hill, OntarioCategory: Producer Inter

41、estChairJ. Bellamy St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementVice-ChairA. Charest Mackenzie Health Richmond Hill Hospital,Richmond Hill, OntarioCategory: General InterestA. Cherton Fresenius Medical Care System,Lachine, QubecCategory: Producer InterestM. Copland Vanco

42、uver Coastal Health, UBC Department ofMedicine,Vancouver, British ColumbiaCategory: General InterestRepresenting Canadian Society of NephrologyF. Corbeil Laboratoire de Sant Publique du Qubec,Ste. Anne-de-Bellevue, QubecCategory: Government and/or Regulatory AuthorityE. Doppler Alberta Health Servic

43、es,Calgary, AlbertaCategory: User ManagementG. Fotiou Mackenzie Health Richmond Hill Hospital,Richmond Hill, OntarioCategory: User ManagementR. Hach FacilicorpNB,Moncton, New BrunswickCategory: User LabourM.R. Heroux Ottawa Hospital,Ottawa, OntarioCategory: User LabourRepresenting Canadian Associati

44、on of NephrologyNurses and Technologists (CANNT)J. Howcroft High Purity Water Services Inc.,Mississauga, OntarioCategory: Producer InterestC. Leduc Ottawa, Ontario AssociateR. Lvesque Hpital Saint-Luc,Montral, QubecCategory: General InterestS. MacNeil Nova Scotia Renal Program,Halifax, Nova ScotiaCa

45、tegory: Government and/or Regulatory AuthorityJ. Plamondon Fraser Health Authority,New Westminster, British ColumbiaCategory: User ManagementS.D. Smith Mar Cor Purification, A Cantel Medical Company,Burlington, OntarioCategory: Producer InterestD. Song Health Canada,Ottawa, OntarioCategory: Governme

46、nt and/or Regulatory AuthorityS. Treesh London Health Sciences Centre,London, OntarioCategory: User LabourB. VanBeek Bayshore Centres Dialysis,Brockville, OntarioCategory: User LabourP. Varga Grand River Hospital,Kitchener, OntarioCategory: Government and/or Regulatory AuthorityRepresenting Ontario

47、Renal NetworkD. Weatherill Regeneration Services,Burlington, OntarioAssociateB. Haydon CSA Group,Toronto, OntarioProject Manager ISO 2014Water for haemodialysis and related therapiesEau pour hmodialyse et thrapies apparentesINTERNATIONAL STANDARDISO13959Third edition2014-04-01Reference numberISO 139

48、59:2014(E)ISO 13959:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or postin

49、g on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgCAN/CSA-ISO 13959:15ISO 13959:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Dialysis water requirements 53.1 Dialysis water verification and mo

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