CAN CSA-Z17510-2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (First Edition).pdf

1、 ISO 2015. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-Z17510:15(ISO 17510:2015, MOD)National Standard of CanadaCAN/CSA-Z17510:15Medical devices Sleep apnoea breathing therapy Masksand application accessories(ISO 17510:2015, MOD)Legal Notice for Stan

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18、he contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this documentconstitutes your acceptance of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-Z17510:15November 2015Title: Medical devices Sleep apnoea breathing thera

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36、-4044.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byMedical devices Sleep apnoeabreathing therapy Masks andapplication accessories(ISO 17510:2015, MOD)CAN/CSA-Z17510:15National Standard of

37、 CanadaCAN/CSA-Z17510:15Medical devices Sleep apnoea breathing therapy Masks andapplication accessoriesNovember 2015 2015 CSA GroupCSA/5CAN/CSA-Z17510:15Medical devices Sleep apnoea breathingtherapy Masks and applicationaccessories(ISO 17510:2015, MOD)CSA PrefaceThis is the first edition of CAN/CSA-

38、Z17510, Medical devices Sleep apnoea breathing therapy Masks and application accessories, which is an adoption, with Canadian deviations, of the identicallytitled ISO (International Organization for Standardization) Standard 17510 (first edition, 2015-08-01). Itreplaces CAN/CSA-Z17510-2-10 (adopted

39、ISO 17510-2:2007).For brevity, this Standard will be referred to as “CAN/CSA-Z17510“ throughout.This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medicalelectrical equipment Part 1: General requirements for basic safety and essential performance(adopted IEC 60601

40、-1:2005+A1:2012, with Canadian deviations).This Standard is considered suitable for use for conformity assessment within the stated scope of theStandard.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on PerioperativeSafety, under the jurisdiction of the CSA Strategic

41、 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.CAN/CSA-Z17510:15Medical devices Sleep apnoea breathing therapy Masks andapplication accessoriesNovember 2015 2015 CSA GroupCSA/7Canadian de

42、viationsThe following deviations are intended to meet Canadian product requirements and to align with theCanadian Electrical Code, Part I.Replace all references to “IEC 60601-1” with “CAN/CSA-C22.2 No. 60601-1”1 ScopeAdd the followingThis Standard covers ME EQUIPMENT that is intended to be installed

43、 or used in accordance withCSA C22.1, Canadian Electrical Code, Part I.2 Normative referencesAdd the following to the list of IEC documentsAny reference to International Standards that are adopted as National Standards of Canada subsequentto the publication of CAN/CSA-Z17510 shall be replaced by the

44、 relevant National Standard of Canada.Add the followingWhere reference is made to CSA Group publications, such reference shall be considered to refer to thelatest edition and all amendments published to that edition. This Standard refers to the followingpublications, and the years shown indicate the

45、 latest editions available at the time of printing:CSA GroupC22.1-15Canadian Electrical Code, Part ICSA Technical Committee on PerioperativeSafetyR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementChairB.W. McLeod Maple Ridge, British ColumbiaCategory: Health Care P

46、rofessionalRepresenting Operating Room Nurses Associationof Canada (ORNAC)Vice-ChairM. Armutlu Jewish General Hospital,Montral, QubecCategory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementRepresenting Community and Hospital InfectionControl

47、 Association of Canada (CHICA)G.D. Burrill Teegor Consulting Inc.,Fredericton, New BrunswickAssociateD.A. Chartrand Montral Neurological Hospital,Montral, QubecCategory: Health Care ProfessionalS. Dain Woodstock Hospital, Department of Anesthesiology,Woodstock, OntarioCategory: Health Care Professio

48、nalN. Dolan Drger Medical Canada Inc.,Mississauga, OntarioAssociateB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestC. Landers Weeneebayko Area Health Authority,Moose Factory, OntarioCategory: General InterestJ.Y. Latreille Clarion Medical Technologies Inc.,Montral, QubecAssociateK.

49、L. LeDez Memorial University of Newfoundland,St. Johns, Newfoundland and LabradorCategory: Health Care ProfessionalT. Martire GE Health Care,Mississauga, OntarioCategory: Producer InterestG.J. Mendes Mississauga, Ontario AssociateP.I. Mendes 3M Canada,London, OntarioAssociateP. Nellis Drger Medical Canada Inc.,Mississauga, OntarioCategory: Producer InterestD.R. Palmerton Buffalo Filter,Lancaster, New York, USAAssociateD.H. Piper MAQUET-DYNAMED Inc.,Markham, OntarioCategory: Producer InterestJ. Rodgers Canadian