CAN CSA-Z5361-2003 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (Second Edition ISO 5361 1999).pdf

1、Reference numberISO 5361:1999(E)Anaesthetic and respiratory equipment Tracheal tubes and connectorsMatriel danesthsie et de ranimation respiratoire Sondes trachales etraccordsNational Standard of CanadaCAN/CSA-Z5361-03International Standard ISO 5361:1999 (first edition, 1999-09-15; corrected and rep

2、rinted 1999-12-15) hasbeen adopted with Canadian deviations (MOD) as CSA Standard CAN/CSA-Z5361-03, which has been approvedas a National Standard of Canada by the Standards Council of Canada.ISBN 1-55397-180-9 May 2003The Canadian Standards Association (CSA), The Standards Council of Canada is theun

3、der whose auspices this National Standard has been coordinating body of the National Standards system, produced, was chartered in 1919 and accredited by a federation of independent, autonomousthe Standards Council of Canada to the National organizations working towards the furtherStandards system in

4、 1973. It is a not-for-profit, development and improvement of voluntarynonstatutory, voluntary membership association standardization in the national interest.engaged in standards development and certification The principal objects of the Council are to foster activities. and promote voluntary stand

5、ardization as a means CSA standards reflect a national consensus of of advancing the national economy, benefiting theproducers and users including manufacturers, health, safety, and welfare of the public, assisting consumers, retailers, unions and professional and protecting the consumer, facilitati

6、ng domestic organizations, and governmental agencies. The and international trade, and furthering internationalstandards are used widely by industry and commerce cooperation in the field of standards.and often adopted by municipal, provincial, and A National Standard of Canada is a standard whichfed

7、eral governments in their regulations, particularly in has been approved by the Standards Council ofthe fields of health, safety, building and construction, Canada and one which reflects a reasonableand the environment. agreement among the views of a number of capableIndividuals, companies, and asso

8、ciations across individuals whose collective interests provide to theCanada indicate their support for CSAs standards greatest practicable extent a balance ofdevelopment by volunteering their time and skills to representation of producers, users, consumers, andCSA Committee work and supporting the A

9、ssociations others with relevant interests, as may be appropriateobjectives through sustaining memberships. The more to the subject in hand. It normally is a standardthan 7000 committee volunteers and the 2000 which is capable of making a significant and timelysustaining memberships together form CS

10、As total contribution to the national interest.membership from which its Directors are chosen. Approval of a standard as a National Standard ofSustaining memberships represent a major source of Canada indicates that a standard conforms to theincome for CSAs standards development activities. criteria

11、 and procedures established by the StandardsThe Association offers certification and testing Council of Canada. Approval does not refer to theservices in support of and as an extension to its technical content of the standard; this remains thestandards development activities. To ensure the continuin

12、g responsibility of the accreditedintegrity of its certification process, the Association standards-development organization.regularly and continually audits and inspects products Those who have a need to apply standards arethat bear the CSA Mark. encouraged to use National Standards of CanadaIn add

13、ition to its head office and laboratory complex whenever practicable. These standards are subject in Toronto, CSA has regional branch offices in major to periodic review; therefore, users are cautioned centres across Canada and inspection and testing to obtain the latest edition from the organizatio

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15、Standards Council of Canadaopen and effective forum for activities facilitating the 270 Albert Street, Suite 200exchange of goods and services through the use of Ottawa, Ontario, K1P 6N7standards, certification and related services to meet Canadanational and international needs.For further informati

16、on on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability

17、for their particular purpose.Registered trade-mark of Canadian Standards AssociationCSA Standards Update ServiceCAN/CSA-Z5361-03May 2003Title: Anaesthetic and respiratory equipment Tracheal tubes and connectorsPagination: 30 pages (CSA/1 and CSA/2, iv, and 23 text)Automatic notifications about any u

18、pdates to this publication are available.To register for email notifications, and/or to download any existing updates in PDF, enter the Online Store at www.csa.ca and click on My Account on the navigation bar.The List ID for this document is 2013946.To receive printed updates, please complete and re

19、turn the attached card.EName Organization Address City Province/State Country Postal/Zip Code Email CAN/CSA-Z5361-03AffranchirsuffisammentPlace Stamp HereASSOCIATION CANADIENNE DE CANADIAN STANDARDSNORMALISATION ASSOCIATIONBUREAU CENTRAL DE LINFORMATION CONSOLIDATED MAILING LIST5060, SPECTRUM WAY, B

20、UREAU 100 5060 SPECTRUM WAY, SUITE 100MISSISSAUGA ON L4W 5N6 MISSISSAUGA ON L4W 5N6CANADA CANADACAN/CSA-Z5361-03 Anaesthetic and respiratory equipment Tracheal tubes and connectorsMay 2003 Canadian Standards Association CSA/1CAN/CSA-Z5361-03Anaesthetic and respiratoryequipment Tracheal tubes andconn

21、ectorsCSA PrefaceThis is the second edition of CAN/CSA-Z5361, Anaesthetic and respiratory equipment Tracheal tubes andconnectors, which is an adoption, with Canadian deviations, of the identically titled ISO (InternationalOrganization for Standardization) Standard 5361 (first edition, 1999-12-15), c

22、urrently available from ISOin English only. It supersedes the first edition published in 1994 under the title Tracheal Tubes (adoptedISO 5361-1:1988, 5361-2:1993, 5361/3-1984, and 5361/5-1984), erroneously identified in the 1994Standard as CSAs fourth edition. This Standard was reviewed for Canadian

23、 adoption by the CSA Subcommittee on AnaestheticEquipment, under the jurisdiction of the Technical Committee on Anaesthetic Equipment, RespiratoryTechnology, and Critical Care Equipment and the Strategic Steering Committee on Health CareTechnology, and has been formally approved by the Technical Com

24、mittee. A list of the members of theTechnical Committee is available upon request. This Standard has been approved as a National Standardof Canada by the Standards Council of Canada. May 2003 Canadian Standards Association 2003All rights reserved. No part of this publication may be reproduced in any

25、 form whatsoever without the prior permission ofthe publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in thetext, they should be interpreted as “this National Standard of Canada”. Inquiries regarding this National Standard of Canada should be

26、addressed to Canadian Standards Association 5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caCAN/CSA-Z5361-03 Anaesthetic and respiratory equipment Tracheal tubes and connectorsCSA/2 Canadian Standards Association May 2003Canadian Deviations7.2.2

27、 Marking on the tracheal tube individual pack and any insert7.2.2.1Add the following itemkA) the term “LATEX-FREE” or “CONTAINS NATURAL LATEX RUBBER” if appropriate.AReference numberISO 5361:1999(E)INTERNATIONALSTANDARDISO5361First edition1999-09-15Corrected and reprinted1999-12-15Anaesthetic and re

28、spiratory equipment Tracheal tubes and connectorsMatriel danesthsie et de ranimation respiratoire Sondes trachales etraccordsISO 5361:1999(E) ISO 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronicor m

29、echanical, including photocopying and microfilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 CH-1211 Genve 20 SwitzerlandInternet isoiso.chiiContentsPage1 Scope 12 Normative references 13 Terms and definitions .14 General requirement

30、s for tracheal tubes and tracheal tube connectors .34.1 Size designation34.2 Dimensions34.3 Materials 94.4 Bevel 94.5 Cuff.104.6 Inflating tubes for cuffs104.7 Curvature of tube105 Additional requirements for tracheal tubes with a Murphy eye125.1 Size of the Murphy eye.125.2 Location of the Murphy e

31、ye .126 Requirements for tracheal tubes with tracheal tube connector supplied sterile136.1 Sterility assurance136.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile137 Marking .137.1 Use of symbols .137.2 Tracheal tubes.147.3 Tracheal tube connectors 15Annex A (normative) D

32、etermination of cuff resting diameter.16 ISOISO 5361:1999(E)iiiAnnex B (normative) Test method for tube collapse. 17Annex C (normative) Test method for cuff herniation. 20Annex D (informative) Guidance on materials and design . 22Bibliography 23ISO 5361:1999(E) ISOivForewordISO (the International Or

33、ganization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been establis

34、hed hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.In

35、ternational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an International Standard requires approval by at least 75 % of the m

36、ember bodies casting a vote.International Standard ISO 5361 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 2, Tracheal tubes and other equipment.This first edition cancels and replaces previous editions of ISO 5361-1:1988, ISO 5361-2:1993, ISO 5

37、361-3:1984,ISO 5361-5:1984 and ISO 7228:1993, which have been technically revised. The requirements of ISO 5361-4:1987,Tracheal tubes Part 4: Cole type, have not been included in this revision because Cole type tubes arespecialized tubes, and as such, are excluded from the scope of this Internationa

38、l Standard.Annexes A, B and C form a normative part of this International Standard.Annex D is for information only. ISOISO 5361:1999(E)vIntroductionThis International Standard specifies the dimensions, basic properties and method of size designation of the mostcommonly used types of tracheal tube ma

39、de of plastics materials and/or rubber. Tubes with walls reinforced withmetal or nylon, tubes with shoulders, tapering tubes and the many other types of tube devised for specializedapplications are not specifically covered, although most may be classified by their inside diameter as required bythis

40、International Standard.While the inside diameter has been specified for size reference, this International Standard requires that the outsidediameter also be marked, since this information is of clinical importance.Clinical considerations have also dictated the apparently excessive specified length

41、of tubes because long tubes,sometimes of relatively narrow diameter, may be urgently required and therefore should be readily available.Provision has also been included for pre-cut tracheal tubes.Cuffed tracheal tubes can be characterized by a combination of the tube inside and outside diameters and

42、 by thecuff resting diameter.For tubes intended for re-use, information on the cuff resting diameter is required to be marked on the package orinsert but not on the tube itself. This is because re-use may alter the elastic properties, and thereby the diameter, ofthe cuff.The relationship between the

43、 cuff and tracheal diameters dictates the intracuff pressure required to provide a seal.Excessive pressure on the tracheal wall may obstruct capillary blood flow.Tracheal tubes, when in position, are intended to conform as closely as possible to human anatomy.A range of cuff designs is available to

44、meet particular clinical requirements. This International Standard requires thatthe resting diameter of the cuff be marked on the unit package, as this information allows the clinician to match theproduct to the application.Herniation in relation to cuffs is a term widely understood in clinical anae

45、sthetic practice. It is used to describe a cuffwhich protrudes excessively at its patient end so that it partially or completely occludes the orifice at the bevel.Herniation may be due to a variety of causes, singly or in combination: these may include over-inflation of the cuff,traction of the tube

46、 when the cuff is inflated or deterioration of the material of the cuff.It should be noted that although certain requirements for cuffs apply to tubes of sizes 2,0 to 4,5, cuffs areinfrequently used on these smaller sizes of tube.Flammability of tracheal tubes, for example if flammable anaesthetics,

47、 electrosurgical units or lasers are used, is awell-recognized hazard1)that is addressed by appropriate clinical management, outside the scope of thisInternational Standard.It is a requirement that tracheal tubes include length mark(s) in centimetres, measured from the patient end. It isrecognized,

48、however, that additional marks, easier to see during intubation, may assist the clinician in positioningthe tracheal tube within the trachea. There is currently, however, no clear consensus on the optimum style andpositioning of these marks and whether the positioning should differ with size of tube

49、. Further clinical data isrequired in order to support inclusion of recommendations for these marks in a future revision of this InternationalStandard.1) See ISO/TR 11991.INTERNATIONAL STANDARD ISO ISO 5361:1999(E)1Anaesthetic and respiratory equipment Tracheal tubesand connectors1 ScopeThis International Standard specifies requirements for the dimensions, basic properties and method of sizedesignation of the most commonly used types of oro-tracheal and naso-tracheal tube made of plastics materialsand/or rubber (plain and c