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
2、dardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensusand develop a stand
3、ard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus, it doesnot independently test, evaluate, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or con
4、ditions of any kind, express or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringementof any third partys intellectual property rights. CSA Group does not warrant the accu
5、racy, completeness, or currency of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicablestatute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED
6、COMPANIES, OR THEIR EMPLOYEES, DIRECTORS,OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED,INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGEDDATA, OR ANY OTHER CO
7、MMERCIAL OR ECONOMIC LOSS,WHETHER BASED IN CONTRACT,TORT (INCLUDING NEGLIGENCE), OR ANY OTHERTHEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUPHAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.I
8、n publishing and making this document available, CSA Group is not undertaking to render professional or other services for or on behalf of anyperson or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directedto those who hav
9、e the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoeverarising in any way from any and all use of or reliance on the information contained in this document.CSA Group is a private not-for-profit company that publishes voluntary standard
10、s and related documents. CSA Group has no power, nor does itundertake, to enforce compliance with the contents of the standards or other documents it publishes.Intellectual property rights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form),
11、 CSA Group is the owner, or the authorizedlicensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and allinventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets
12、 are protected bypatents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document mayviolate laws that protect CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legalredr
13、ess for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectualproperty rights in this document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights.
14、 CSA Group shall not beheld responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity ofany such patent rights is entirely their own responsibility.Authorized use of this documentThis document is being provided by CSA G
15、roup for informational and non-commercial use only. The user of this document is authorized to doonly the following:If this document is in electronic form: load this document onto a computer for the sole purpose of reviewing it; search and browse this document; and print this document if it is in PD
16、F format.Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA Group to have suchcopies, and only if this 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 rem
17、ove this Legal Notice from the attached standard; sell this document without authorization from CSA Group; or make an electronic copy of this document.If you do not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document or make anycopies of t
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
19、py Masks and applicationaccessoriesTo 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 2424247.If you require assistance, please e-mail techsupportcsagroup
20、.org or call 416-747-2233.Visit CSA Groups policy on privacy at www.csagroup.org/legal to find out how we protect yourpersonal information.Canadian Standards Association (operating as “CSA Group”), underwhose auspices this National Standard has been produced, waschartered in 1919 and accredited by t
21、he Standards Council ofCanada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged instandards development and certification activities.CSA Group standards reflect a national consensus of producers andusers including manufacturers,
22、consumers, retailers, unions andprofessional organizations, and governmental agencies. Thestandards are used widely by industry and commerce and oftenadopted by municipal, provincial, and federal governments in theirregulations, particularly in the fields of health, safety, building andconstruction,
23、 and the environment.Individuals, companies, and associations across Canada indicatetheir support for CSA Groups standards development byvolunteering their time and skills to Committee work and supportingCSA Groups objectives through sustaining memberships. The morethan 7000 committee volunteers and
24、 the 2000 sustainingmemberships together form CSA Groups total membership fromwhich its Directors are chosen. Sustaining memberships represent amajor source of income for CSA Groups standards developmentactivities.CSA Group offers certification and testing services in support of andas an extension t
25、o its standards development activities. To ensurethe integrity of its certification process, CSA Group regularly andcontinually audits and inspects products that bear theCSA Group Mark.In addition to its head office and laboratory complex in Toronto, CSAGroup has regional branch offices in major cen
26、tres across Canadaand inspection and testing agencies in eight countries. Since 1919,CSA Group has developed the necessary expertise to meet itscorporate mission: CSA Group is an independent serviceorganization whose mission is to provide an open and effectiveforum for activities facilitating the ex
27、change of goods and servicesthrough the use of standards, certification and related services tomeet national and international needs.For further information on CSA Group services, write toCSA Group178 Rexdale BoulevardToronto, Ontario, M9W 1R3CanadaA National Standard of Canada is a standard develop
28、ed by an SCC-accredited Standards Development Organization (SDO), andapproved by the Standards Council of Canada (SCC), in accordancewith SCCs: Requirements and Guidance Accreditation forStandards Development Organizations, and Requirements andGuidance Approval of National Standards of Canada Design
29、ation.More information on National Standard requirements can be foundat www.scc.ca.An SCC-approved standard reflects the consensus of a number ofexperts whose collective interests provide, to the greatestpracticable extent, a balance of representation of affectedstakeholders. National Standards of C
30、anada are intended to make asignificant and timely contribution to the Canadian interest.SCC is a Crown corporation within the portfolio of Industry Canada.With the goal of enhancing Canadas economic competitiveness andsocial well-being, SCC leads and facilitates the development and useof national a
31、nd international standards. SCC also coordinatesCanadian participation in standards development, and identifiesstrategies to advance Canadian standardization efforts.Accreditation services are provided by SCC to various customers,including product certifiers, testing laboratories, and standardsdevel
32、opment organizations. A list of SCC programs and accreditedbodies is publicly available at www.scc.ca.Users should always obtain the latest edition of a National Standardof Canada from the standards development organization responsiblefor its publication, as these documents are subject to periodicre
33、view.Standards Council of Canada600-55 Metcalfe StreetOttawa, Ontario, K1P 6L5CanadaCette Norme Nationale du Canada est disponible en versions franaise et anglaise.Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsib
34、ility ofthe users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”ICS 11.040.10ISBN 978-1-4883-0233-6 2015 CSA GroupAll rights reserved. No part of this publication may be reproduced in any form whatsoeverwithout the
35、 prior permission of the publisher.Published in November 2015 by CSA GroupA not-for-profit private sector organization178 Rexdale Boulevard,Toronto, Ontario, Canada M9W 1R3To purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747
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
