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

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

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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