1、Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipmentCAN/CSA-Z17510-1-10(ISO 17510-1:2007, MOD)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a conse
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18、ns of this Legal Notice.CSA Standards Update ServiceCAN/CSA-Z17510-1-10January 2010Title:Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipmentPagination:46 pages (CSA/1CSA/6, ivi, and 34 text)To register for e-mail notification about any updates to this publicationgo to www
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33、ada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.AlthoughtheintendedprimaryapplicationofthisStandardisstatedinitsScope,itisimportanttonotethatitremainstheresponsibilityoftheuserstojudgeitssuitabilityfortheirparticularpu
34、rpose.Registeredtrade-markofCanadianStandardsAssociationReviewed byNational Standard of CanadaPublished in January 2010 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our
35、Online Store at www.ShopCSA.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-Z17510-1-10Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipmentCAN/CSA-Z17510-1-10Sleep apnoea breathing therapy Part 1:Sleep apnoea breathi
36、ng therapy equipmentCSA/4 Canadian Standards Association January 2010CAN/CSA-Z17510-1-10Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipmentCSA PrefaceThis is the second edition of CAN/CSA-Z17510-1, Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equi
37、pment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 17510-1 (second edition, 2007-10-01). It supersedes the previous edition, published in 2003 as CAN/CSA-Z17510-1 (adopted ISO 17510-1:2002).This Standard was
38、reviewed for Canadian adoption by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally
39、approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.January 2010 Canadian Standards Association 2010All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permiss
40、ion of thepublisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association
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42、estions for their improvement will be referred to the appropriate committee. To submit a proposal for change to CSA Standards, please send the following information to inquiriescsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table,
43、and/or figure number;(c) wording of the proposed change; and(d) rationale for the change.CAN/CSA-Z17510-1-10Sleep apnoea breathing therapy Part 1:Sleep apnoea breathing therapy equipmentJanuary 2010 Canadian Standards Association CSA/5Canadian deviations2 Normative referencesAdd the followingCSA (Ca
44、nadian Standards Association)The following National Standards of Canada, published by the Canadian Standards Association, are adoptions of IEC and ISO Standards. The requirements of these CSA Standards shall take precedence over the International Standards on which they are based; any reference in C
45、AN/CSA-Z17510-1 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard.CAN/CSA-C22.2 No. 60529-05Degrees of protection provided by enclosures (IP Code)CAN/CSA-C22.2 No. 60601-1-08Medical electrical equipment Part 1: General requ irements for basic safety a
46、nd essential performanceCAN/CSA-C22.2 No. 60601-1-1-02 (R2006)Medical electrical equipment Part 1-1: General requ irements for safety Collateral standard: Safety requirements for medical electrical systemsCAN/CSA-C22.2 No. 60601-1-2-08Medical electrical equipment Part 1-2: General requ irements for
47、basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and testsCAN/CSA-C22.2 No. 60601-1-6-08Medical electrical equipment Part 1-6: General requ irements for basic safety and essential performance Collateral standard: UsabilityCAN/CSA-C22.2 No. 60601-
48、1-8-08Medical electrical equipment Part 1-8: General requ irements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsCAN/CSA-ISO 14937-01 (R2006)Sterilization of hea
49、lth care products General requirem ents for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-ISO 14971-07Medical devices Application of ri sk management to medical devicesCAN/CSA-Z5356-1-08Anaesthetic and respiratory equipment Coni cal connectors Part 1: Cones and socketsCAN/CSA-Z5356-2-08Anaesthetic and respiratory equipment Conical co nnectors Part 2: Screw-threaded weight-bearing connectors CAN/CSA-Z5359-09Low-press