CAN CSA-Z17510-2010 Sleep apnoea breathing therapy - Part 1 Sleep apnoea breathing therapy equipment (Second Edition).pdf

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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

2、nsus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA administers the process and establishes rules to promote fairness in achievin

3、g consensus, it does not independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or condit

4、ions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA makes no repre

5、sentations or warranties regarding this documents compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES,

6、 INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIAB

7、ILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or other services

8、 for or on behalf of any person or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever a

9、rising in any way from any and all use of or reliance on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or

10、other documents it publishes. Intellectual property rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as

11、 otherwise noted to the contrary), and all inventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of th

12、is document may violate laws that protect CSAs and/or others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights i

13、n this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the v

14、alidity of any such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:.load th

15、is document onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document if it is in PDF format. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have such copies, and only if this

16、 Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not agree wi

17、th any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditio

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

19、.ShopCSA.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2419749.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at www.csagroup.

20、org/legal to find out how we protect your personal information.TheCanadianStandardsAssociation(CSA),under whose auspices this National Standard hasbeen produced, was chartered in 1919 andaccredited by the Standards Council of Canadato the National Standards system in 1973. It is anot-for-profit, non

21、statutory, voluntary membershipassociation engaged in standards development andcertification activities.CSA standards reflect a national consensus ofproducers and users including manufacturers,consumers, retailers, unions and professionalorganizations, and governmental agencies. Thestandards are use

22、d widely by industry and commerceand often adopted by municipal, provincial, andfederal governments in their regulations, particularlyin the fields of health, safety, building andconstruction, and the environment.Individuals, companies, and associations acrossCanada indicate their support for CSAs s

23、tandardsdevelopment by volunteering their time and skillsto CSA Committee work and supporting theAssociations objectives through sustainingmemberships. The more than 7000 committeevolunteers and the 2000 sustaining membershipstogether form CSAs total membership from whichits Directors are chosen. Su

24、staining membershipsrepresent a major source of income for CSAsstandards development activities.The Association offers certification and testingservices in support of and as an extension to itsstandards development activities. To ensure theintegrity of its certification process, the Associationregul

25、arly and continually audits and inspects productsthat bear the CSA Mark.In addition to its head office and laboratorycomplex in Toronto, CSA has regional branch officesin major centres across Canada and inspection andtesting agencies in eight countries. Since 1919, theAssociation has developed the n

26、ecessary expertise tomeet its corporate mission: CSA is an independentservice organization whose mission is to provide anopen and effective forum for activities facilitating theexchange of goods and services through the use ofstandards, certification and related services to meetnational and internat

27、ional needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaTheStandardsCouncilofCanada(SCC)is thecoordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations worki

28、ng towards the furtherdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare of the public, assistingan

29、d protecting the consumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or reviewed by an accredited StandardsDevelopment Organization (SDO) and approvedby the SCC according t

30、o the requirements of CAN-P-2.Approval does not refer to the technical content of thestandard; this remains the continuing responsibility ofthe SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective interests provide,to the greatest practicable extent, a balance ofrepres

31、entation of general interests, producers,regulators, users (including consumers), and otherswith relevant interests, as may be appropriate to thesubject in hand. It normally is a standard which iscapable of making a significant and timely contributionto the national interest.Those who have a need to

32、 apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO whichpublishes the standard.The responsibility for approving standards asNational Standards of Canada rests with theStandards Council of Can

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

41、5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-free 1-800-463-6727 or 416-747-4044.CSA Standards are subject to periodic review, and sugg

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

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