CAN CSA-ISO 13958-2015 Concentrates 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 13958:15(ISO 13958:2014, IDT)National Standard of CanadaCAN/CSA-ISO 13958:15Concentrates for haemodialysis and related therapies(ISO 13958:2014, IDT)Legal Notice for StandardsCanadian Standar

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36、free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byConcentrates for haemodialysis and relatedtherapies(ISO 13958:2014, IDT)CAN/CSA-ISO 13958:15National Stand

37、ard of CanadaCAN/CSA-ISO 13958:15 Concentrates for haemodialysis and related therapiesNovember 2015 2015 CSA GroupCSA/5CAN/CSA-ISO 13958:15Concentrates for haemodialysis andrelated therapies(ISO 13958:2014, IDT)CSA PrefaceThis is the second edition of CAN/CSA-ISO 13958, Concentrates for haemodialysi

38、s and related therapies,which is an adoption without modification of the identically titled ISO (International Organization forStandardization) Standard 13958 (third edition, 2014-04-01). It supersedes the previous editionpublished in 2011 as CAN/CSA-ISO 13958 (adopted ISO 13958:2009). At the time o

39、f publication, ISO13958:2014 is available 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 13958” throughout.This Standard was reviewed for Canadian adoption by the CSA Technical Commi

40、ttee on Kidney Dialysisunder the jurisdiction 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,Rich

41、mond Hill, OntarioCategory: Producer InterestChairJ. 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, QubecC

42、ategory: Producer InterestM. Copland Vancouver 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

43、 AuthorityE. Doppler Alberta Health Services,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:

44、User LabourRepresenting Canadian Association 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 S

45、cotia Renal Program,Halifax, Nova ScotiaCategory: 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 Healt

46、h Canada,Ottawa, OntarioCategory: Government 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

47、 Regulatory AuthorityRepresenting Ontario Renal NetworkD. Weatherill Regeneration Services,Burlington, OntarioAssociateB. Haydon CSA Group,Toronto, OntarioProject Manager ISO 2014Concentrates for haemodialysis and related therapiesConcentrs pour hmodialyse et thrapies apparentesINTERNATIONAL STANDAR

48、DISO13958Third edition2014-04-01Reference numberISO 13958:2014(E)ISO 13958:2014(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, elec

49、tronic or mechanical, including photocopying, or posting 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 13958:15ISO 13958:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and defi