CSA Z364 2 1-2013 Monitoring systems for hemodialysis equipment (Third Edition).pdf

1、Z364.2.1-13Monitoring systems for hemodialysis equipmentLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers repres

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18、e.Standards Update ServiceZ364.2.1-13March 2013Title: Monitoring systems for hemodialysis equipmentTo register for e-mail notification 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 2422

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20、ed to any form whatsoever without the prior permission of the publisher.Published in March 2013 by CSA Group A not-for-profit private sector organization 5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 To purchase standards and related publications, visit our Online Store at shop.

21、csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association, operating as “CSA Group”Monitoring systems for hemodialysis equipmentZ364.2.1-13Z364.2.1-13Monitoring systems for hemodialysis equipmentMarch 2013 2013 CSA Group 1ContentsTechnical Committe

22、e on Kidney Dialysis 3Preface 51 Scope 61.1 General 61.2 Exclusions 61.3 Terminology 62 Reference publications 73 Definitions 84 Quality management 84.1 Policies 84.2 Standard operating procedures 94.2.1 General 94.2.2 Development, approval, and distribution 94.2.3 Document control 104.2.4 Storage a

23、nd retention 114.3 Personnel 114.3.1 General 114.3.2 Training 124.3.3 Competency assessment and proficiency testing 124.3.4 Records 124.4 Dialysis support services 124.5 Health and safety 134.5.1 General 134.5.2 Biological safety 134.5.3 Chemical safety 134.6 Quality assurance system 135 Fluid quali

24、ty 145.1 Incoming water quality 145.2 Concentrate quality 145.3 Dialysis fluid quality 145.4 Quality assurance 146 Biocompatibility 147 Disinfection 157.1 Hemodialysis machines and accessories 157.2 Hydraulic fluid path 157.3 Blood tubing transducer protectors 168 Dialysing fluid and blood circuits

25、systems Maintenance 168.1 Hemodialysis monitors and alarms 16Z364.2.1-13Monitoring systems for hemodialysis equipmentMarch 2013 2013 CSA Group 28.2 Hydraulic and blood circuit components 169 Electrical safety 1710 Labelling and documentation requirements 1711 Tests 17Z364.2.1-13Monitoring systems fo

26、r hemodialysis equipmentMarch 2013 2013 CSA Group 3Technical Committee on Kidney DialysisJ. Maahs Gambro, Richmond Hill, OntarioRepresenting Producer InterestsChairM.C. Heroux Ottawa Hospital, Ottawa, OntarioRepresenting User Interests LabourVice-ChairJ. Bellamy St. Josephs Healthcare Hamilton, Hami

27、lton, OntarioRepresenting User Interests ManagementA. Charest York Central Hospital, Richmond Hill, OntarioRepresenting General InterestsA. Cherton Fresenius Medical Care System, Lachine, QubecRepresenting Producer InterestsM. Copland Vancouver Coastal Health, UBC Division of Medicine, Vancouver, Br

28、itish ColumbiaRepresenting General InterestsF. Corbeil Laboratoire de Sant Publique du Qubec, Ste. Anne-de-Bellevue, QubecRepresenting Government/Regulatory AuthoritiesC. Estridge Toronto General Hospital, University Health Network, Toronto, OntarioRepresenting User Interests ManagementG. Fotiou Yor

29、k Central Hospital, Richmond Hill, OntarioRepresenting User Interests ManagementR. Hach FacilicorpNB, Moncton, New BrunswickRepresenting User Interests LabourJ. Howcroft High Purity Water Services Inc., Mississauga, OntarioRepresenting Producer InterestsZ364.2.1-13Monitoring systems for hemodialysis

30、 equipmentMarch 2013 2013 CSA Group 4C. Leduc Baxter Corp., Ottawa, OntarioRepresenting Producer InterestsR. Lvesque Hpital Saint-Luc, Montral, QubecRepresenting General InterestsS. MacNeil Nova Scotia Renal Program, Halifax, Nova ScotiaRepresenting Government/Regulatory AuthoritiesS.D. Smith Mar Co

31、r Purification, a Cantel Medical Company, Burlington, OntarioRepresenting Producer InterestsD. Song Health Canada, Ottawa, OntarioRepresenting Government/Regulatory AuthoritiesS. Treesh London Health Sciences Centre, London, OntarioRepresenting User Interests LabourB. VanBeek Bayshore Centres Dialys

32、is, Brockville, OntarioRepresenting User Interests LabourD. Weatherill Regeneration Services, Burlington, OntarioAssociateC. Cortissoz CSA Group, Mississauga, OntarioProject ManagerZ364.2.1-13Monitoring systems for hemodialysis equipmentMarch 2013 2013 CSA Group5PrefaceThis is the third edition of C

33、SA Z364.2.1, Monitoring systems for hemodialysis equipment. It supersedes the previous edition published in 1994 under the title Fluid Supply and Monitoring Systems for Haemodialysis.This Standard was prepared by the Technical Committee on Kidney Dialysis, under the jurisdiction of the Strategic Ste

34、ering Committee on Health Care Technology, and has been formally approved by the Technical Committee.Notes:1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.2) Although the intended primary application of this Standard is stated in its Scope, it is important t

35、o note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.3) This Standard was developed by consensus, which is defined by CSA Policy governing standardization Code of good practice for standardization as “substantial agreement. Cons

36、ensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included in the Technical Committee list and yet not be in full agreement with all clauses of this Standard.4) To submit a request for interpretation of this Sta

37、ndard, please send the following information to inquiriescsagroup.organd include “Request for interpretation” in the subject line:a) define the problem, making reference to the specific clause, and, where appropriate, include an illustrative sketch;b) provide an explanation of circumstances surround

38、ing the actual field condition; andc) where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current S

39、tandards Activities page at standardsactivities.csa.ca.5) This Standard is subject to periodic review, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiriescsagroup.organd include “Propos

40、al for change” in the subject line:a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.Z364.2.1-13Monitoring systems for hemodialysis equipmentMarch 2013 2013 CSA Group 6Z364.2.1-13Monitoring systems for h

41、emodialysis equipment1 Scope1.1 GeneralThis Standard specifies requirements for the safe use, disinfection, testing, and maintenance of monitoring systems for hemodialysis. It is intended for use by dialysis providers, including health care workers and professionals who perform technical and operati

42、onal functions associated with hemodialysis. This Standard applies toa) quality management;b) monitoring of fluid quality systems;c) maintenance requirements;d) biocompatibility of material components;e) disinfection of the hydraulic fluid path and blood tubing transducer protectors;f) dialysing flu

43、id and blood circuit systems; andg) equipment testing electrical safety.1.2 ExclusionsThis Standard does not include requirements fora) systems that regenerate the dialysing fluid;b) dialysers;c) blood tubings;d) blood access devices;e) hemoperfusion devices;f) hemofiltration systems that do not pro

44、duce on-line fluid; andg) the frequency of monitoring of the purity of water used for dialysing fluid.Notes:1) For requirements for hemodialysers, hemodiafilters, hemofilters, hemoconcentrators, and the associated extracorporeal circuits, users should consult CAN/CSA-ISO 8637 and CAN/CSA-ISO 8638.2)

45、 For requirements for monitoring water quality, users should consult CAN/CSA-ISO 11663, CAN/CSA-ISO 13959, and CAN/CSA-ISO 26722.1.3 TerminologyIn this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “sho

46、uld” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the standard.Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompan

47、ying a clause is to separate from the text explanatory or informative material.Notes to tables and figures are considered part of the table or figure and may be written as requirements.Z364.2.1-13Monitoring systems for hemodialysis equipmentMarch 2013 2013 CSA Group 7Annexes are designated normative

48、 (mandatory) or informative (nonmandatory) to define their application.2 Reference publicationsThis Standard refers to the following publications, and where such reference is made, it shall be to the edition listed below, including all amendments published thereto.CSA GroupCAN/CSA-C22.2 No. 60601 se

49、ries of StandardsMedical electrical equipmentCAN/CSA-C22.2 No. 60601-1:08 (R2013)Medical electrical equipment Part 1: General requirements for basic safety and essential performanceCAN/CSA-C22.2 No. 60601-1-1:02 (R2011)Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systemsCAN/CSA-C22.2 No. 60601-2-16-09Medical electrical equipment Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltrat