CAN CSA-ISO 5364-2014 Anaesthetic and respiratory equipment - Oropharyngeal airways (First Edition).pdf

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1、 ISO 2008. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 5364:14(ISO 5364:2008, IDT)National Standard of CanadaCAN/CSA-ISO 5364:14Anaestheticand respiratory equipmentOropharyngealairways(ISO 5364:2008, IDT)LegalNotice for StandardsCanadian Standard

2、s 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 standard. Although CSA Grou

3、p administers the process and establishes rules to promote fairness in achieving consensus,it doesnot independently test, evaluate, or verify the content of standards.Disclaimerand exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, exp

4、ress or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particularpurpose or use, its merchantability, or its non-infringementof any third partys intellectual property rights. CSA Group does not warrant the accuracy, completeness, or cu

5、rrency of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliancewith any applicablestatute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOY

6、EES, DIRECTORS, OROFFICERS, 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 DAMAGED DATA,OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS,WH

7、ETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OFLIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUP HAS BEENADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making thi

8、s document available, CSA Group is not undertaking to render professional or other servicesfor 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 have the appropriate degree of

9、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 standards and related documents. CSA

10、 Group has no power, nor does itundertake, to enforce compliancewith the contents of the standards or other documents it publishes.Intellectualpropertyrights and ownershipAs between CSA Group and the users of this document (whether it be in printed or electronic form), CSA Group is the owner, or the

11、 authorizedlicensee,of all works contained herein that are protected by copyright, all trade-marks (except as otherwisenoted to the contrary), and allinventions and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patentsand appl

12、ications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate lawsthat protect CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to seek legal redress forsuch use, modification, c

13、opying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights inthis document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. CSA Group shall not be heldrespo

14、nsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any suchpatent rights is entirely their own responsibility.Authorizeduse of this documentThis document is being provided by CSA Group for informational and non-com

15、mercial 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 PDF format.Limited copies of this do

16、cument in print or paper form may be distributed only to persons who are authorized by CSA Group to have such copies,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 remove this Legal Notice from the att

17、ached 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 the contents hereof, and if you do

18、make such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.StandardsUpdateServiceCAN/CSA-ISO 5364:14October 2014Title: Anaesthetic and respiratory equipment OropharyngealairwaysTo register for e-mail

19、 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 2423516.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on priv

20、acy at csagroup.org/legalto find out how we protect your personalinformation.CanadianStandards Association (operating as “CSA Group”), underwhose auspicesthis National Standard has been produced, waschartered in 1919 and accredited by the Standards Council of Canadato the National Standards system i

21、n 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, consumers, retailers, unions andprofessional organizations, and g

22、overnmental agencies. Thestandards are used widely by industry and commerce and oftenadopted by municipal, provincial, and federal governments in theirregulations, particularlyin the fields of health, safety, building andconstruction, and the environment.Individuals, companies, and associationsacros

23、s Canada indicate theirsupport for CSA Groups standards development by volunteeringtheir time and skills to Committee work and supporting CSA Groupsobjectivesthrough sustaining memberships. The more than 7000committee volunteers and the 2000 sustaining membershipstogether form CSA Groups total membe

24、rship from which itsDirectors are chosen. Sustaining memberships represent a majorsource of income for CSA Groups standards development activities.CSA Group offers certification and testing servicesin support of andas an extension to its standards development activities. To ensurethe integrity of it

25、s 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 centres across Canadaand inspection and testing agencies in eight count

26、ries. Since 1919,CSA Group has developed the necessaryexpertise to meet itscorporate mission: CSA Group is an independent service organizationwhose mission is to provide an open and effective forum foractivities facilitating the exchange of goods and servicesthrough theuse of standards, certificatio

27、n and related servicesto meet nationaland international needs.For further information on CSA Group services,write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Councilof Canada (SCC) is the coordinating body ofthe Canadian standardization network, which is c

28、omposed of peopleand organizations involved in the development,promotion andimplementation of standards. Through the collaborative efforts ofCanadian standardization network members, standardization ishelping to advance the social and economic well-being of Canada andto safeguard the health and safe

29、ty of Canadians.The networksefforts are overseen by SCC.The principal objectives of SCC are to foster and promote voluntarystandardization as a means of advancing the national economy,supporting sustainable development,benefiting the health, safetyand welfare of workers and the public, assisting and

30、 protecting theconsumer, facilitating domestic and international trade, andfurthering international cooperation in relation to standardization.An important facet of the Canadian standards development system isthe use of the following principles: consensus;equal access andeffective participation by c

31、oncerned interests; respect for diverseinterests and identification of those who should be afforded accessto provide the needed balance of interests; mechanismfor disputeresolution; opennessand transparency;open access by interestedparties to the procedures guiding the standards developmentprocess;

32、clarity with respect to the processes; and Canadian interestconsideration as the initial basis for the development of standards.A National Standard of Canada (NSC) is a standard prepared orreviewed by an SCC-accredited SDO and approved by the SCCaccording to NSC approval requirements. Approval does

33、not refer tothe technical content of the standard, as this remains theresponsibility of the SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective interests provide, to the greatestpracticable extent, a balance of representation of general interests,producers, regulators

34、, users (including consumers) and others withrelevant interests, as may be appropriate to the subject at hand.NSCs are intended to make a significant and timely contribution tothe Canadian interest.Those who have a need to apply standards are encouraged to useNSCs. These standards are subjectto peri

35、odic review. Users of NSCsare cautioned to obtain the latest edition from the SDO thatpublishes the standard.The responsibility for approving standards as NSCs rests withStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme Nationale du Canada est disponibl

36、e en versions franaise et anglaise.Although the intended primaryapplication of this Standard is stated in its Scope, it is important to note that it remainsthe responsibility of theusers to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association,operat

37、ing as “CSA Group”ICS 11.040.10ISBN 978-1-77139-849-7 2014 CSA GroupAll rights reserved.No part of this publication may be reproduced in any form whatsoever withoutthe prior permission of the publisher.Published in October 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Wa

38、y, Suite 100, Mississauga, Ontario, Canada L4W 5N6To purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational O

39、rganization for StandardizationApproved byAnaestheticand respiratoryequipmentOropharyngealairways(ISO 5364:2008,IDT)CAN/CSA-ISO 5364:14National Standard of CanadaCAN/CSA-ISO 5364:14Anaesthetic and respiratory equipment OropharyngealairwaysOctober 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 5364:14Anaestheti

40、cand respiratoryequipmentOropharyngealairways(ISO 5364:2008,IDT)CSA PrefaceThis is the first edition of CAN/CSA-ISO 5364, Anaesthetic and respiratory equipment Oropharyngealairways, which is an adoption without modification of the identically titled ISO (InternationalOrganization for Standardization

41、) Standard 5364 (fourth edition, 2008-07-15;corrected version2009-01-15).For brevity, this Standard will be referred to as “CAN/CSA-ISO 5364” throughout.This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to ISO/TC 121,under the jurisdiction of the CSA Technical Commit

42、tee on Perioperative Safety and the CSA StrategicSteering Committee on Health Care Technology and Systems, and has been formally approved by theTechnical Committee. This Standard has been approved as a National Standard of Canada by theStandards Council of Canada. 2014 CSA GroupAll rights reserved.N

43、o part of this publication may be reproducedin any form whatsoeverwithout theprior permission of the publisher. ISO material is reprinted with permission. Where the words “thisInternational Standard” appear in the text, they should be interpreted as “this National Standard ofCanada”.Inquiries regard

44、ing this National Standard of Canada should be addressedtoCSA Group5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada, L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free1-800-463-6727or 416-747-

45、4044.This Standard is subject to review five years from the date of publication, and suggestions for itsimprovementwill be referred to the appropriate committee. To submit a proposal for change, please sendthe following information to inquiriescsagroup.organd include“Proposal for change” in the subj

46、ectline:a) Standard designation (number);b) relevant clause,table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committeeon PerioperativeSafetyR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementChairB.W. McLeod

47、 Maple Ridge, British ColumbiaCategory: Health Care ProfessionalVice-ChairM. Armutlu Jewish General Hospital,Montral, QubecCategory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementD.A. Chartrand Montreal Neurological Hospital,Montral, QubecCa

48、tegory: Health Care ProfessionalJ.D.Y. Deslauriers Consultant,Gatineau, QubecCategory: Governmentand/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc.,Mississauga, OntarioCategory: Producer InterestB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestC. Landers Weeneebayko Gener

49、al Hospital,Moose Factory, OntarioCategory: General InterestJ.Y. Latreille Clarion Medical Technologies Inc.,Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland,St. Johns, Newfoundland and LabradorCategory: Health Care ProfessionalG. Mendes GE Healthcare Technologies,Mississauga, OntarioCategory: Producer InterestP.I. Mendes 3M Canada,London, OntarioAssociateD.R. Palmerton Buffalo Filter,Lancaster, New York, USAAssociateD.H. Piper MAQUET-DYNAMED Inc.,Markham,OntarioCategory: Producer InterestM. Sagar WorkSafe BC,Vancouver, Br

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