CAN CSA-ISO 11663-2015 Quality of dialysis fluid for haemodialysis and related therapies (Second Edition).pdf

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36、k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byQuality of dialysis fluid forhaemodialysis and related therapies(ISO 11663:2014, IDT)CAN/CSA-ISO 11663:15National Standard of CanadaCAN/CSA-ISO 11663:15 Qua

37、lity of dialysis fluid for haemodialysis and related therapiesDecember 2015 2015 CSA GroupCSA/5CAN/CSA-ISO 11663:15Quality of dialysis fluid for haemodialysisand related therapies(ISO 11663:2014, IDT)CSA PrefaceThis is the second edition of CAN/CSA-ISO 11663, Quality of dialysis fluid for haemodialy

38、sis and relatedtherapies, which is an adoption without modification of the identically titled ISO (InternationalOrganization for Standardization) Standard 11663 (second edition, 2014-04-01). It supersedes theprevious edition published in 2011 as CAN/CSA-ISO 11663 (adopted ISO 11663:2009).For brevity

39、, this Standard will be referred to as “CAN/CSA-ISO 11663” throughout.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Kidney Dialysisunder the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology b) relevant clause, table, and/or figure nu

40、mber;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committee on Kidney DialysisJ. Maahs Baxter-Gambro Renal,Richmond Hill, OntarioCategory: Producer InterestChairJ. Bellamy St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementVice-ChairA. Chares

41、t Mackenzie Health Richmond Hill Hospital,Richmond Hill, OntarioCategory: General InterestA. Cherton Fresenius Medical Care System,Lachine, QubecCategory: Producer InterestM. Copland Vancouver Coastal Health, UBC Department ofMedicine,Vancouver, British ColumbiaCategory: General InterestRepresenting

42、 Canadian Society of NephrologyF. Corbeil Laboratoire de Sant Publique du Qubec,Ste. Anne-de-Bellevue, QubecCategory: Government and/or Regulatory AuthorityE. Doppler Alberta Health Services,Calgary, AlbertaCategory: User ManagementG. Fotiou Mackenzie Health Richmond Hill Hospital,Richmond Hill, Ont

43、arioCategory: User ManagementR. Hach FacilicorpNB,Moncton, New BrunswickCategory: User LabourM.R. Heroux Ottawa Hospital,Ottawa, OntarioCategory: User LabourRepresenting Canadian Association of NephrologyNurses and Technologists (CANNT)J. Howcroft High Purity Water Services Inc.,Mississauga, Ontario

44、Category: Producer InterestC. Leduc Ottawa, Ontario AssociateR. Lvesque Hpital Saint-Luc,Montral, QubecCategory: General InterestS. MacNeil Nova Scotia Renal Program,Halifax, Nova ScotiaCategory: Government and/or Regulatory AuthorityJ. Plamondon Fraser Health Authority,New Westminster, British Colu

45、mbiaCategory: User ManagementS.D. Smith Mar Cor Purification, A Cantel Medical Company,Burlington, OntarioCategory: Producer InterestD. Song Health Canada,Ottawa, OntarioCategory: Government and/or Regulatory AuthorityS. Treesh London Health Sciences Centre,London, OntarioCategory: User LabourB. Van

46、Beek Bayshore Centres Dialysis,Brockville, OntarioCategory: User LabourP. Varga Grand River Hospital,Kitchener, OntarioCategory: Government and/or Regulatory AuthorityRepresenting Ontario Renal NetworkD. Weatherill Regeneration Services,Burlington, OntarioAssociateB. Haydon CSA Group,Toronto, Ontari

47、oProject Manager ISO 2014Quality of dialysis fluid for haemodialysis and related therapiesQualit des fluides de dialyse pour hmodialyse et thrapies apparentesINTERNATIONAL STANDARDISO11663Second edition2014-04-01Reference numberISO 11663:2014(E)ISO 11663:2014(E)ii ISO 2014 All rights reservedCOPYRIG

48、HT 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 posting on the internet or an intranet, without prior written permissio

49、n. 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 11663:15ISO 11663:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 64.1 Microbiological contaminants in dialysis fluid 64.2 Chemical contaminants in dialysis fluid 75