1、BS EN ISO5366-1:2009ICS 11.040.10,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDAnaesthetic andrespiratory equipment Tracheostomy tubesPart 1: Tubes and connectors for use inadults (ISO 5366-1:2000)Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2
2、009 02:44, Uncontrolled Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July2009 BSI 2009ISBN 978 0 580 65617 0Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 5366-1:2009National forewordThis British Stand
3、ard is the UK implementation of EN ISO 5366-1:2009. It is identical to ISO 5366-1:2000. It supersedes BS EN ISO 5366-1:2004 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organ
4、izations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligatio
5、ns.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 5366-1April 2009ICS 11.040.10 Supersedes EN ISO 5366-1:2004 English VersionAnaesthetic and respiratory equipment - Tracheostomy tubes -Part 1: T
6、ubes and connectors for use in adults (ISO 5366-1:2000)Matriel danesthsie et de ranimation respiratoire - Tubesde trachostomie - Partie 1: Tubes et raccords pour adultes(ISO 5366-1:2000)Ansthesie- und Beatmungsgerte - Tracheotomietuben -Teil 1: Tuben und Verbindungsstcke zur Anwendung beiErwachsenen
7、 (ISO 5366-1:2000)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibli
8、ographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of
9、a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland,
10、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000
11、Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 5366-1:2009: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009EN ISO 5366-1:2009 (E) 3 Foreword
12、 The text of ISO 5366-1:2000 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 5366-1:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”
13、 the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention
14、 is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5366-1:2004. This document has been prepared under a mandate gi
15、ven to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the nationa
16、l standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol
17、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 5366-1:2000 has been approved by CEN as a EN ISO 5366-1:2009 without any modification. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontroll
18、ed Copy, (c) BSIBS EN ISO 5366-1:2009EN ISO 5366-1:2009 (E) 4 Annex ZA (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European
19、Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at lea
20、st one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence betwe
21、en this European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 1 N/A 2 N/A 3 N/A 4 1, 2 a), 3 5 1, 2 a), 3, 7.1 a), 7.1 b), 7.2 6 1, 2, 3, 9.2 a) 6.1 4, 9.1, 9.3 6.1.1 7.5 6.1.4 7.5 6.2 4 6.3 9.1, 9.3 6.4.1
22、4 6.4.2 4 6.5.2.1 2 b) 6.5.3 9.1 6.7 4 7.1 8.1, 8.3, 8.4 7.2.2 5, 8.1, 8.3 8.1 13.2, 13.3 g) m), 13.4 8.2 13.1 8.2.1 a) 13.3 b) 8.2.1 b) 13.3 b), 2 c) 8.2.1 c) 13.3 a) 8.3 13.1, 13.3 e) 8.3.1 13.2 8.3.2 a) 13.3 b), 13.4 8.3.2 b) 13.3 b) 8.3.2 d) 13.3 b) 8.3.2 e) 13.3 b) 8.3.2 f) 13.3 b) Licensed Cop
23、y: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009EN ISO 5366-1:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 8.3.2 g) 13.3 a) 8.3.2 h) 13.3 d), 13.5 8.3.2 i) 8.6, 1
24、3.6 h) 8.3.2 j) 8.1, 8.3, 8.7, 13.2, 13.3 b), c) 8.3.2 k) 13.3 b) 8.3.2 l) 2 c), 13.3 b) 8.3.3 13.3 e) 8.3.3 a) 13.3 b), 13.4 8.3.3 b) 13.3 b) 8.3.3 c) 13.3 b) 8.3.3 d) 13.3 a) 8.3.3 e) 13.3 d), 13.5 8.3.3 f) 8.6, 13.6 h) 8.3.3 g) 8.1, 8.3, 8.7, 13.2, 13.3 b), c) 8.3.3 h) 13.3 b), d) f), 13.5 Annex
25、C 4, 7.1 b), 7.3, 9.2 a) C.1.2 13.6 h) C.1.3 9.3 - 1 (2nd paragraph, 1st dash) (2nd paragraph, 2nd dash) These parts of this Essential Requirement are not addressed in this Standard - 6a) This part of this Essential Requirement is not addressed in this Standard - 7.1 (3rd dash) This part of this Ess
26、ential Requirement is not addressed in this Standard - 7.5 (1st paragraph) This part of this Essential Requirement is not fully addressed in this European Standard - 7.5 (2nd paragraph) This part of this Essential Requirement is not fully addressed in this European Standard - 13.3 (a): This relevant
27、 Essential Requirement is not fully addressed in this European Standard - 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009EN ISO 5366-
28、1:2009 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes - 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 13.6 (h)(3rd paragraph) This relevant Essential Requirement is
29、 not addressed in this European Standard - 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard N/A = not applicable WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. Licensed Copy: Wa
30、ng Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009ISO 5366-1:2000(E) ISO 2000 All rights reserved iiiContents Page1 Scope . 12 Normative references . 13 Terms and definitions 14 Size designation and dimensions . 45 Materials . 66 Design and finish
31、 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 tracheostomy tube 10A.1 Principle 10A.2 Apparatus 10A.3 Procedure . 10A.4 Expression of results . 10B Test method for determining th
32、e 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 Design . 12Bibliography. 13Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSI
33、BS EN ISO 5366-1:2009ISO 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 technica
34、l 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 closely wi
35、th 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 the me
36、mber 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 for id
37、entifying 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 the secon
38、d 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 tracheostom
39、y tubesAnnexes A and B form a normative part of this part of ISO 5366. Annex C is for information only.Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009ISO 5366-1:2000(E) ISO 2000 All rights reserved vIntroductionISO 5366-1 is on
40、e of a series of International Standards dealing with anaesthetic equipment, and is concerned withthe basic requirements 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 intende
41、d for spontaneously breath-ing patients, and those with reinforced walls or tubes made of metal are excluded from 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 tracheos
42、tomy tubes with an inside diameter from to for paediatricuse.The method of describing tube dimensions and configuration 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 d
43、iameter, which is important because of its relation to resistance to gas flow. Because the stomal and trachealdiameters 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 combinat
44、ion of the tube inside and outside diameters and bythe cuff resting diameter.The relationship of cuff and tracheal 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
45、meet the particular clinical requirements. This part of ISO 5366 requires thatthe resting diameter of the cuff is 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 trac
46、heostomy tubes, as for tra-cheal tubes, to ensure compatibility with the breathing system of an anaesthetic machine 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
47、 tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units, or lasers are usedin oxidant-enriched 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,
48、0 mm15 mmLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIThis page deliberately left blankLicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 15/10/2009 02:44, Uncontrolled Copy, (c) BSIBS EN ISO 5366-1:2009INTERNATIONAL STANDARD ISO 5366-1:2000(
49、E) ISO 2000 All rights reserved 1Anaesthetic and respiratory equipment 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-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 flammabili
