ANSI AAMI 5366-1-2000 Anaesthetic and Respiratory Equipment-Tracheostomy Tubes-Part 1 Tubes and Connectors for Use in Adults.pdf

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1、ANSI/AAMI/ISO 5366-1: 2000Anaesthetic and Respiratory EquipmentTracheostomy TubesPart 1: Tubes and Connectors for Use in Adults American National StandardThis document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting ha

2、s been maintained, so there are some variations from the typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Right

3、s Reserved This publication is subject to copyright claims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted

4、to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil

5、 and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. P

6、rinted in the United States of America ISBN 1570205337 ANS/ISO 5366-1 2000(E) Anaesthetic and Respiratory Equipment Tracheostomy Tubes Part 1: Tubes and Connectors for Use in Adults Approved as an American National Standard by: ASTM International These materials are subject to copyright claims of IS

7、O, ANSI, and ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International. INTERNATIONALSTANDARDISO5366-1F

8、ourth 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 adultsMatriel danesthsie et de ranimation respiratoire Tubes detrachostomie Partie 1: Tubes et raccords p

9、our adultesISO 5366-1:2000(E)ii ISO 2000 All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not beedited unless the typefaces which are embedded are licensed to and installed on the c

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12、entral Secretariat at the address given below. ISO 2000All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec-tronic or mechanical, including photocopying and microfilm, without permission in writing from either IS

13、O at the address below or ISOs mem-ber body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.chWeb www.iso.chPrinted in SwitzerlandISO 5366-1:2000(E) ISO 2000 All rights reserved iiiContents Page1 Scop

14、e . 12 Normative references . 13 Terms and definitions 14 Size designation and dimensions . 45 Materials . 66 Design and finish 67 Requirements for tracheostomy tubes supplied sterile . 78 Marking and labelling 8AnnexesA Test method for the security of attachment of connector and neck-plate to trach

15、eostomy tube 10A.1 Principle 10A.2 Apparatus 10A.3 Procedure . 10A.4 Expression of results . 10B Test method for determining the resting diameter of the cuff 11B.1 Principle 11B.2 Apparatus 11B.3 Procedure . 11B.4 Expression of results . 11C Guidance on materials and design . 12C.1 Materials . 12C.2

16、 Design . 12Bibliography. 13ISO 5366-1:2000(E)iv ISO 2000 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO t

17、echnical com-mittees. Each member body interested in a subject for which a technical committee has been established has theright to be represented on that committee. International organizations, governmental and non-governmental, in liai-son with ISO, also take part in the work. ISO collaborates clo

18、sely with the International Electrotechnical Commission(IEC) on all matters of electrotechnical standardization.International 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

19、 the member bodies for voting.Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this part of ISO 5366 may be the subject of patentrights. ISO shall not be held responsible

20、 for identifying any or all such patent rights.International Standard ISO 5366-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 2, Tracheal tubes and other equipment.This fourth edition cancels and replaces the third edition of ISO 5366-1 and th

21、e second edition of ISO 5366-2(ISO 5366-1:1994 and ISO 5366-2:1993), which have been technically revised.ISO 5366 consists of the following parts, under the general title Anaesthetic and respiratory equipment Tracheos-tomy tubes: Part 1: Tubes and connectors for use in adults Part 3: Paediatric trac

22、heostomy tubesAnnexes A and B form a normative part of this part of ISO 5366. Annex C is for information only.ISO 5366-1:2000(E) ISO 2000 All rights reserved vIntroductionISO 5366-1 is one of a series of International Standards dealing with anaesthetic equipment, and is concerned withthe basic requi

23、rements and method of size designation of tracheostomy tubes made of plastics materials and/or rub-ber. Specialized tubes, for example those without a connector at the machine end intended for spontaneously breath-ing patients, and those with reinforced walls or tubes made of metal are excluded from

24、 the scope of this part ofISO 5366.This part of ISO 5366 specifies requirements for tracheostomy tubes with an inside diameter of or greater.ISO 5366-3 specifies requirements for tracheostomy tubes with an inside diameter from to for paediatricuse.The method of describing tube dimensions and configu

25、ration has been devised in order to assist the clinician in theselection of a suitable tube to conform as far as possible to a particular patients anatomy. Size is designated by in-side diameter, which is important because of its relation to resistance to gas flow. Because the stomal and trachealdia

26、meters are important when selecting tubes, it is considered essential that the outside diameter be stated for eachsize of tube.Cuffed tracheostomy tubes can be characterized by a combination of the tube inside and outside diameters and bythe cuff resting diameter.The relationship of cuff and trachea

27、l diameters dictates the intra-cuff pressures required to provide a seal. Excessivepressure on the tracheal wall can obstruct capillary blood flow.A range of cuff designs is available to meet the particular clinical requirements. This part of ISO 5366 requires thatthe resting diameter of the cuff is

28、 marked on the unit package, as this information allows the clinician to match theproduct to the application.A male conical connector in accordance with ISO 5356-1 should be used for tracheostomy tubes, as for tra-cheal tubes, to ensure compatibility with the breathing system of an anaesthetic machi

29、ne or ventilator.The tracheostomy tube connector should be permanently attached to the tracheostomy tube to prevent inadvertentdisconnection of the connector from the tube.Flammability of tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units, or lasers are usedin oxidant-e

30、nriched atmospheres, is a well-recognized hazard1)that is addressed by appropriate clinical manage-ment, and is outside the scope of this part of ISO 5366.1) See ISO/TR 11991.6,5 mm2,0 6,0 mm15 mmINTERNATIONAL STANDARD ISO 5366-1:2000(E) ISO 2000 All rights reserved 1Anaesthetic and respiratory equi

31、pment Tracheostomy tubes Part 1:Tubes and connectors for use in adults1 ScopeThis part of ISO 5366 specifies requirements for tracheostomy tubes made of plastics materials and/or rubber havinginside diameters of or greater. Such tubes are primarily designed for patients who require anaesthesia, arti

32、-ficial ventilation or other respiratory support, but need not be restricted to these uses.This part of ISO 5366 is not applicable to specialized tubes, and does not address flammability of tracheostomytubes.2 Normative referencesThe following normative documents contain provisions which, through re

33、ference in this text, constitute provisions ofthis part of ISO 5366. For dated references, subsequent amendments to, or revisions of, any of these publications donot apply. However, parties to agreements based on this part of ISO 5366 are encouraged to investigate the possi-bility of applying the mo

34、st recent editions of the normative documents indicated below. For undated references, thelatest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currentlyvalid International Standards.ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes

35、, needles and certain other medical equipment Part 1: General requirements.ISO 4135, Anaesthetic and respiratory equipment Vocabulary.ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets.ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and conn

36、ectors.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing.ISO 11607, Packaging for terminally sterilized medical devices.EN 556 :1994, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE”.3 Terms and definitionsFor the purposes

37、of this part of ISO 5366, the terms and definitions given in ISO 4135 and the following apply.3.1tracheostomy tubetube designed for insertion into the trachea through a tracheostomyNOTE See Figure 1 a) and b) for an illustration of a typical tracheostomy tube and the associated nomenclature.6,5 mmIS

38、O 5366-1:2000(E)2 ISO 2000 All rights reserveda) View 1Key1 Inflating tube2 Neck-plate3 Cuff, if present4 Patient end5 Alternative integralpilot balloon/valveassembly6 male conicalfitting in accordancewith ISO 5356-17 Machine end8 Outer tube9 Pilot balloon10 Inflation valve orclosure device11 Tip ro

39、unded12 Bevel, if presentb) View 2Figure 1 Typical tracheostomy tube15 mmISO 5366-1:2000(E) ISO 2000 All rights reserved 33.2machine endGe1of a tracheostomy tubeGf1 that end which is intended to project from the neck of a patient3.3machine endGe1of a connector or an adaptorGf1 that end intended to m

40、ate with the breathing system of an anaesthetic machine or ven-tilator3.4patient endthat end of a tracheostomy tube which is intended to be inserted into the trachea3.5nominal lengthdistance from the patient side of the neck-plate to the patient end along the centrelineSeeFigure2.NOTE When the neck-

41、plate is movable, the nominal length is variable.Key1 Centreline2 Neck-plate3 Datum planeNOTE The angle is the obtuse angle formed between the long axes of the tube at the machine and patient ends.Figure 2 Basic dimensions of tracheostomy tubesISO 5366-1:2000(E)4 ISO 2000 All rights reserved3.6outer

42、 tubethat part of the tracheostomy tube which is normally in contact with the tissues3.7inner tubetube which fits closely to the inside contours of the outer tube (i.e. a tracheostomy tube)3.8cuffinflatable balloon permanently attached around the tracheostomy tube near the patient end to provide a s

43、eal be-tween the tube and the trachea3.9inflating tubetube through which a cuff is inflated3.10pilot balloonballoon fitted to an inflating tube to indicate inflation of a cuff3.11neck-plateshieldthat part of a tracheostomy tube which approximates to the contour of a patients neck and is used to secu

44、re the tubein position3.12introducerobturatorspecially adapted stylet to facilitate the introduction of the outer tube into the trachea3.13bevelslanted portion at the patient end of a tracheostomy tube3.14angle of bevelacute angle between the plane of the bevel and the longitudinal axis of a tracheo

45、stomy tube at the patient end4 Size designation and dimensions4.1 Inside diameter4.1.1 The size of the tracheostomy tube (outer tube) shall be designated by the nominal inside diameter (ID) of thetube, expressed in millimetres, as measured at the minimum inside diameter, in accordance with Table 1,

46、excludingany encroachment allowed by 6.5.1.ISO 5366-1:2000(E) ISO 2000 All rights reserved 54.1.2 For tracheostomy tubes with the conical connector permanently attached to the inner tube, the size shall bedesignated by the nominal inside diameter (ID) of the inner tube, expressed in millimetres, in

47、accordance withTable 1.4.2 Outside diameter4.2.1 The outside diameter (OD) of sections and (see Figure 2) of the tube, other than at the cuff, if provided,shall be expressed in millimetres to the nearest .NOTE The stated outside diameter relates to that portion of the tube intended to be within the

48、wall and the lumen of the trachea.4.2.2 The actual outside diameter of section (see Figure 2) other than at the cuff, if provided, shall be the markedoutside diameter subject to a tolerance of .4.2.3 The actual outside diameter of section shall be the marked outside diameter subject to a tolerance o

49、f.4.3 Length4.3.1 The nominal length (dimensions + + in Figure 2) shall be measured from the patient side of the neck-plate to the patient end including the bevel, if present, and expressed in millimetres.4.3.2 The actual nominal length (dimensions + + in Figure 2) shall be the marked nominal length subject to atolerance of .4.3.3 For tubes with an adjustable neck-plate, the range of measurements for nominal length (see Figure 2) shall beexpressed in millimetres.4.3.4 Dimensions , and shall be expressed in m