1、ANSI/AAMI/ISO 5366-3: 2001Anaesthetic and Respiratory EquipmentTracheostomy TubesPart 3: Paediatric Tracheostomy Tubes 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 has been ma
2、intained, 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 Rights Reserve
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6、 the United States of America ISBN 1570205345 ANS/ISO 5366-3 2001/Cor. 1:2003(E) Anaesthetic and Respiratory Equipment Tracheostomy Tubes Part 3: Paediatric Tracheostomy Tubes Approved as an American National Standard by: ASTM International These materials are subject to copyright claims of ISO, ANS
7、I, 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. ICS 11.040.10 Ref. No. ISO 5366-3:200
8、1/Cor.1:2003(E) ISO 2003 All rights reserved Published in Switzerland INTERNATIONAL STANDARD ISO 5366-3:2001 TECHNICAL CORRIGENDUM 1 Published 2003-01-15INTERNATIONAL ORGANIZATION FOR STANDARDIZATION x F?MG:JHG:Y HJ=:GBA:PBY IH KL:G:JLBA:PBB x ORGANISATION INTERNATIONALE DE NORMALISATIONAnaesthetic
9、and respiratory equipment Tracheostomy tubes Part 3: Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1 Matriel respiratoire et danesthsie Tubes de trachostomie Partie 3: Tubes de trachostomie pdiatriques RECTIFICATIF TECHNIQUE # Technical Corrigendum 1 to ISO 5366-3:2001 was prepared by Technica
10、l Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Tracheal tubes and other equipment. Page 9 Clause A.1 In the first sentence, replace “.axial separation force to the neck-plate” with “.axial separation force to the tube, relative to the neck-plate.” In the second sen
11、tence, replace “.axial separation force to the connector” with “.axial separation force to the tube, relative to the connector.” Subclause A.2.2 Replace “.to the tracheostomy tube.” with “.and the tracheostomy tube.”. ISO 5366-3:2001/Cor.1:2003(E) 2 ISO 2003 All rights reservedSubclause A.2.3 Replac
12、e “.to the tracheostomy tube.” with “.and the tracheostomy tube.”. Subclause A.3.3 Replace “.axial separation force of (50 r 5) N to the connector.” with “.axial separation force of (50 r 5) N to the tracheostomy tube, relative to the connector.”. Subclause A.3.5 Replace “.axial separation force to
13、the neck-plate.” with “.axial separation force to the tracheostomy tube, relative to the neck-plate.”. INTERNATIONALSTANDARDISO5366-3Second edition2001-08-15Reference numberISO 5366-3:2001(E) ISO 2001Anaesthetic and respiratory equipment Tracheostomy tubes Part 3:Paediatric tracheostomy tubesMatriel
14、 respiratoire et danesthsie Tubes de trachostomie Partie 3: Tubes de trachostomie pdiatriquesISO 5366-3:2001(E)ii ISO 2001 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 beedi
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18、including photocopying and microfilm, without permission in writing from either ISO 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
19、 SwitzerlandISO 5366-3:2001(E) ISO 2001 All rights reserved iiiContents Page1 Scope . 12 Normative references . 13 Terms and definitions 14 Size designation and dimensions . 25 Materials . 46 Design and finish 47 Requirements for tracheostomy tubes supplied sterile . 68 Marking . 6AnnexesA Test for
20、security of attachment of permanently attached connector, if provided, and neck-plate to tracheostomytube. 9B Test method for determining the resting diameter of the cuff 10C Guidance on materials and design . 11Bibliography. 12ISO 5366-3:2001(E)iv ISO 2001 All rights reservedForewordISO (the Intern
21、ational 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 technicalcommittees. Each member body interested in a subject for which a technical committee has bee
22、n established 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 standard
23、ization.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 the member bodies for voting.Publication as an International Standard requires approval by at least 75
24、% 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 for identifying any or all such patent rights.International Standard ISO 5366-3 was prepared by Technic
25、al Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 2, Tracheal tubes and other equipment.This second edition cancels and replaces the first edition (ISO 5366-3:1994), which has been technically revised.ISO 5366 consists of the following parts, under the general title Anae
26、sthetic and respiratory equipment Tracheostomy tubes: Part 1: Tubes and connectors for use in adults Part 3: Paediatric tracheostomy tubesAnnexes A and B form a normative part of this part of ISO 5366. Annex C is for information only.ISO 5366-3:2001(E) ISO 2001 All rights reserved vIntroductionISO 5
27、366 is concerned with the basic requirements and method of size designation of tracheostomy tubes made ofplastics materials and/or rubber.ISO 5366-1 gives requirements for adult tracheostomy tubes made of plastics materials and/or rubber.This part of ISO 5366 gives requirements for paediatric trache
28、ostomy tubes with an inside diameter from to.Paediatric tracheotomy tubes are primarily intended for use with infants and children who may require anaesthesia,artificial ventilation, relief of upper airway obstruction or other respiratory therapy.An infant or child differs from an adult, not only in
29、 size but especially with regard to airway anatomy and respiratoryphysiology; thus airway equipment for paediatric patients differs from that for adults in size and also in basic design.It should be noted that, although this part of ISO 5366 gives some requirements for cuffs, cuffs are seldom provid
30、edon the smaller sizes of paediatric tubes.This part of ISO 5366 gives requirements for those characteristics of tracheostomy tubes that can be standardizedand which are important for patient safety. It does not require the connector to be permanently attached to the tube,as this may be impractical
31、with infants and small children. Other acceptable methods of connecting thesecomponents are available, and this part of ISO 5366 makes provision for them. This part of ISO 5366 does not limitthe range of tube designs needed to match the variety of paediatric anatomy, lesions and space limitationsenc
32、ountered.The method of describing tube dimensions and configuration has been devised with the aim of assisting the clinicianin the selection of a suitable tube to conform as far as possible to a particular patients anatomy. Size is designatedby inside diameter, which is important because of its rela
33、tion to resistance to gas flow. Because the stomal andtracheal diameters are important when selecting tubes, it is considered essential that the outside diameter be statedfor each size of tube.A tracheostomy tube can increase resistance to gas flow. For tubes with a given outside diameter, differenc
34、es in wallthickness have a major influence on the resistance to gas flow, especially in the smaller sizes of paediatrictracheostomy tubes.Flammability of tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units or lasers are usedin oxidant-enriched atmospheres, is a well-reco
35、gnized hazard1)addressed by appropriate clinical management,which is outside the scope of this part of ISO 5366.1) See ISO/TR 11991.2,0 mm6,0 mmINTERNATIONAL STANDARD ISO 5366-3:2001(E) ISO 2001 All rights reserved 1Anaesthetic and respiratory equipment Tracheostomy tubes Part 3:Paediatric tracheost
36、omy tubes1 ScopeThis part of ISO 5366 gives requirements for paediatric tracheostomy tubes made of plastics materials and/or rubberhaving inside diameters from to . Requirements for paediatric tracheostomy tube connectors andadaptorsarealsogiven.This part of ISO 5366 is not applicable to specialized
37、 tracheostomy tubes.2 Normative referencesThe following normative documents contain provisions which, through reference 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, partie
38、s to agreements based on this part of ISO 5366 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undated references,the latest edition of the normative document referred to applies. Members of ISO and IEC maintain regist
39、ers ofcurrently valid International Standards.ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements.ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets.ISO 5361, Anaestheti
40、c and respiratory equipment Tracheal tubes and connectors.ISO 5366-1:2000, Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectorsfor use in adults.ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing.ISO 11607, Packaging for terminally s
41、terilized medical devices.EN 556:1994, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE”.3 Terms and definitionsFor the purposes of this part of ISO 5366, the terms and definitions given in ISO 5366-1 and the following apply.3.1paediatric tracheostomy tubetub
42、e designed for insertion into the trachea of an infant or child through a tracheostomy3.2paediatric tracheostomy tube connectortubular component which fits directly into the paediatric tracheostomy tube2,0 mm 6,0 mmISO 5366-3:2001(E)2 ISO 2001 All rights reserved3.3machine endGe1paediatric tracheost
43、omy tube connectorGf1 end of the component nearest the machine which is intended to mate withthe breathing system of an anaesthetic machine or lung ventilator3.4patient endGe1paediatric tracheostomy tube connectorGf1 end of the component nearest the patient which is inserted into thepaediatric trach
44、eostomy tube4 Size designation and dimensions4.1 Designation of size of tube4.1.1 The size of a tracheostomy tube (outer tube) shall be designated by the nominal inside diameter (ID) of thetube expressed in millimetres, as measured at the minimum diameter, in accordance with Table 1, excluding anyen
45、croachment allowed by 6.6.1.4.1.2 For tracheostomy tubes provided with an inner tube to which is attached a male conical connectorcomplying with the requirements of ISO 5356-1 see 6.1 a), the size shall be designated by the nominal insidediameter (ID) of the inner tube expressed in millimetres in ac
46、cordance with Table 1.4.2 Outside diameter4.2.1 The outside diameter (OD) of sections A and C (see Figure 1) of the tube, other than at the cuff if provided,shall be expressed in millimetres to the nearest .NOTE The marked outside diameter relates to that portion of the tube intended to be within th
47、e wall and lumen of the trachea.4.2.2 The actual outside diameter of section A, other than at the cuff if provided, shall be the marked outsidediameter subject to a tolerance of .4.2.3 The actual outside diameter of section C shall be the marked outside diameter subject to a tolerance of.Table 1 Siz
48、e designation, inside diameter and tolerancesof paediatric tracheostomy tubesDimensions in millimetresDesignated size Inside diameter Tolerance2,0 2,02,5 2,53,0 3,03,5 3,54,0 4,04,5 4,55,0 5,05,5 5,56,0 6,015 mm+0,20+0,300,1 mm0,2 mm0,5 mmISO 5366-3:2001(E) ISO 2001 All rights reserved 34.3 Length4.
49、3.1 The nominal length ( in Figure 1) shall be measured from the patient side of the neck-plate to thepatient end, including the bevel if present (see Figure 1), and expressed in millimetres.4.3.2 The actual nominal length ( in Figure 1) shall be the marked nominal length subject to a toleranceof for tubes with a marked inside diameter of less than , or subject to a tolerance of fortubes with a marked inside diameter of or greater.a) Paediatric
