CAN CSA-ISO 15197-2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (Second Edition).pdf

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1、 ISO 2013. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 15197:15(ISO 15197:2013, IDT)National Standard of CanadaCAN/CSA-ISO 15197:15 In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing di

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37、proved byIn vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self- testing in managing diabetes mellitus (ISO 15197:2013, IDT)CAN/CSA-ISO 15197:15National Standard of CanadaCAN/CSA-ISO 15197:15In vitro diagnostic test systems Requirements for blood- glucose monitor

38、ing systems for self-testing in managing diabetes mellitusAugust 2015 2015 CSA GroupCSA/5CAN/CSA-ISO 15197:15In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013, IDT)CSA Preface This is the second edition o

39、f CAN/CSA-ISO 15197, In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15197 (second edit

40、ion, 2013-05-15). It supersedes the previous edition published in 2005 as CAN/CSA-ISO 15197 (adopted ISO 15197:2003). For brevity, this Standard will be referred to as “CAN/CSA-ISO 15197” throughout.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Laboratory

41、 Quality Systems, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology CAN/CSA-ISO 15197:15In vitro diagnostic test systems Requirements for blood- glucose monitoring systems for self-testing in managing diabetes mellitusAugust 2015 2015 CSA GroupCSA/6b) relevant

42、clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committee on Medical Laboratory Quality SystemsS.M. Woodcock QSE Consulting Inc., Rose Bay, Nova Scotia Category: General InterestChairG.J. Flynn Institute for Quality Management in He

43、althcare, Toronto, Ontario Category: Regulatory AuthorityVice-ChairL.C. Allen Canadian Society of Clinical Chemists (CSCC), Georgetown, Ontario Category: User InterestM. Carballo Health Canada, Medical Devices Bureau, Ottawa, Ontario Category: Regulatory AuthorityJ. Coffey Institute for Quality Mana

44、gement in Healthcare, Toronto, Ontario AssociateJ.G. Dalton Dalton Health Care Consulting, Winnipeg, Manitoba Category: General InterestA.M. Dolan University of Toronto, Toronto, Ontario AssociateM.B. Dolovich St Josephs Hospital / McMaster University, Hamilton, Ontario AssociateC. Draghici Standard

45、s Council of Canada (SCC), Ottawa, Ontario AssociateE. Dunn Gamma-Dynacare Medical, Brampton, Ontario Category: User InterestC. Geraghty Standards Council of Canada (SCC), Ottawa, Ontario AssociateA. Ghalami University of Toronto, Toronto, Ontario AssociateM. Heisz Public Health Agency of Canada (PH

46、AC), Ottawa, Ontario AssociateK. Huckabone Thermo Fisher Scientific Inc., Ottawa, Ontario Category: Producer InterestN. Levin Ortho Clinical Diagnostics, Markham, Ontario Category: Producer InterestA.M. Martel Ordre Professionnel des Technologistes Mdicaux du Qubec, Montral, Qubec Category: Regulato

47、ry AuthorityL. McBride College of Physicians and Surgeons of Alberta, Edmonton, Alberta Category: Regulatory AuthorityC.M. Nielsen Canadian Society for Medical Laboratory Science (CSMLS), Hamilton, Ontario Category: User InterestM.A. Noble The University of British Columbia, Department of Pathology

48、and Lab Medicine, Vancouver, British Columbia Category: General InterestJ.P. Philley British Columbia Ministry of Health Services, Vancouver, British Columbia Category: Regulatory AuthorityK. Ramotar The Ottawa Hospital, Ottawa, Ontario Category: User InterestR. Rennie RP Rennie Consultations Ltd.,

49、Sherwood Park, Alberta Category: General InterestJ.S. Roberts Alere Inc., Ottawa, Ontario Category: Producer InterestC. Robertson Public Health Agency of Canada, National Microbiology Laboratory, Winnipeg, Manitoba AssociateP. Rostron Siemens Healthcare Diagnostics Ltd., Mississauga, Ontario Category: Producer InterestD. Sarakbi Accreditation Canada, Ottawa, Ontario Category: General InterestD.W. Seccombe Canadian External Quality Assessment Laboratory, Vancouver, British Columbia AssociateI. Seiden Long Calgary Laboratory Services, Calga