CAN CSA-ISO 5366-1-2014 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1 Tubes and connectors for use in adults (First Edition).pdf

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1、 ISO 2000. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 5366-1:14(ISO 5366-1:2000, IDT)National Standard of CanadaCAN/CSA-ISO 5366-1:14Anaestheticand respiratory equipmentTracheostomytubes Part 1: Tubes and connectors for use in adults(ISO 5366-1:

2、2000, IDT)LegalNotice for StandardsCanadian 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 achiev

3、e consensusand develop a standard. 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.Disclaimerand exclusion of liabilityThis document is provided without any represe

4、ntations, warranties, or conditions of any kind, express 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 Grou

5、p does not warrant the accuracy, completeness, or currency 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, SU

6、BSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, 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 DAMA

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8、OSS, COSTS, OR EXPENSES.In publishing and making this 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

9、directedto those who have 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 publ

10、ishes voluntary standards and related documents. CSA 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

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12、s and trade secrets are protected by patentsand applications 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 other

13、s to seek legal redress forsuch use, modification, copying, 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 subjec

14、t of patent rights. CSA Group shall not be heldresponsible 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

15、 provided by CSA Group 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 docum

16、ent 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 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

17、 in any way or remove 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 m

18、ake anycopies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.Standards UpdateServiceCAN/CSA-ISO 5366-1:14February 2014Title: Anaesthetic and respirat

19、ory equipment Tracheostomy tubes Part 1: Tubes andconnectors for use in adultsTo 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 2422940.If you require as

20、sistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legalto find out how we protect your personalinformation.CanadianStandards Association (operating as “CSA Group”), underwhose auspicesthis National Standard has been produced, wasc

21、hartered in 1919 and accredited by the Standards Council of Canadato 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

22、 andusers including manufacturers, 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, particularlyin the fields of health,

23、 safety, building andconstruction, and the environment.Individuals, companies, and associationsacross Canada indicate theirsupport for CSA Groups standards development by volunteeringtheir time and skills to Committee work and supporting CSA Groupsobjectivesthrough sustaining memberships. The more t

24、han 7000committee volunteers and the 2000 sustaining membershipstogether form CSA Groups total membership 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

25、 support of andas an extension to 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 regi

26、onal branch offices in major centres across Canadaand inspection and testing agencies in eight countries. 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 fo

27、ractivities facilitating the exchange of goods and servicesthrough theuse of standards, certification and related servicesto meet nationaland international needs.For further information on CSA Group services,write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standard

28、s Councilof Canada (SCC) is the coordinating body ofthe Canadian standardization network, which is composed of peopleand organizations involved in the development,promotion andimplementation of standards. Through the collaborative efforts ofCanadian standardization network members, standardization i

29、shelping to advance the social and economic well-being of Canada andto safeguard the health and safety 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 susta

30、inable development,benefiting the health, safetyand welfare of workers and the public, assisting and protecting theconsumer, facilitating domestic and international trade, andfurthering international cooperation in relation to standardization.An important facet of the Canadian standards development

31、system isthe use of the following principles: consensus;equal access andeffective participation by concerned interests; respect for diverseinterests and identification of those who should be afforded accessto provide the needed balance of interests; mechanismfor disputeresolution; opennessand transp

32、arency;open access by interestedparties to the procedures guiding the standards developmentprocess; 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

33、 an SCC-accredited SDO and approved by the SCCaccording to NSC approval requirements. Approval does 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 th

34、e greatestpracticable extent, a balance of representation of general interests,producers, regulators, 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.Th

35、ose who have a need to apply standards are encouraged to useNSCs. These standards are subjectto periodic 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

36、 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette 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 remainsthe responsibility of theusers to judge its

37、 suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”ICS 11.040.10ISBN 978-1-77139-525-0 2014 CSA GroupAll rights reserved.No part of this publication may be reproduced to any form whatsoever withoutthe prior permission of the publis

38、her.Published in February 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, 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

39、 k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byAnaestheticand respiratoryequipmentTracheostomy tubes Part 1: Tubes andconnectorsfor use in adults(ISO 5366-1:2000,IDT)CAN/CSA-ISO 5366-1:14National Standa

40、rd of CanadaCAN/CSA-ISO 5366-1:14Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adultsFebruary 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 5366-1:14Anaestheticand respiratoryequipmentTracheostomy tubes Part 1: Tubes andconnectorsfor use in adults(ISO 5366-1:

41、2000,IDT)CSA PrefaceThis is the first edition of CAN/CSA-ISO 5366-1, Anaesthetic and respiratory equipment Tracheostomytubes Part 1: Tubes and connectors for use in adults, which is an adoption without modification of theidentically titled ISO (International Organization for Standardization) Standar

42、d 5366-1 (fourth edition,2000-12-15;corrected and reprinted 2001-09-01).For brevity, this Standard will be referred to as“CAN/CSA-ISO 5366-1” 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

43、tee on Perioperative Safety and the CSA StrategicSteering Committee on Health Care Technology b) relevant clause,table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committeeon PerioperativeSafetyS. Taylor London, OntarioCategory: General Inter

44、estChairM. Armutlu Jewish General Hospital,Montral, QubecCategory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton,Hamilton, OntarioCategory: User ManagementD.A. Chartrand Montreal Neurological Hospital,Montral, QubecCategory: Health Care ProfessionalJ.D. Deslauriers Health Canada,Ott

45、awa, OntarioCategory: Governmentand/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc.,Richmond Hill, OntarioAssociateB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementC. Landers Weeneebayko G

46、eneral 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 ProfessionalB.W. McLeod Maple Ridge, British ColumbiaCatego

47、ry: Health Care ProfessionalG. Mendes GE Healthcare Technologies,Mississauga, OntarioCategory: Producer InterestP.I. Mendes 3M Canada,London, OntarioAssociateD.H. Piper MAQUET-DYNAMED Inc.,Markham,OntarioCategory: Producer InterestM. Sagar WorkSafe BC,Vancouver, British ColumbiaCategory: Governmenta

48、nd/or Regulatory AuthorityR.C. Shantz Parkin Architects Limited,Toronto, OntarioCategory: General InterestP.J. Smalley Technology Concepts International,Chicago, Illinois, USACategory: General InterestC. Stark London Health Sciences Centre,London, OntarioAssociateH. Thiemann Medical Device Industry

49、Consultant,Perkasie, Pennsylvania, USACategory: Producer InterestK.L. Warcimaga Selkirk and District General Hospital,Selkirk, ManitobaCategory: User ManagementJ. Wilding Drger Medical Canada Inc.,Richmond Hill, OntarioCategory: Producer InterestC. Cortissoz CSA Group,Mississauga, OntarioProject ManagerINTERNATIONALSTANDARDISO5366-1Fourth edition2000-12-15Reference numberISO 5366-1:2000(E) ISO 2000Corrected and reprinted2001-09-01Anaesthetic and respiratory equipment Tracheostomy tubes Part 1:Tubes and connectors for use in adultsMat

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