EN 1282-2-2005 en Tracheostomy tubes - Part 2 Paediatric tubes (Incorporates Amendment A1 2009)《气管造口插管 第2部分 儿科用管 包含修改件A1-2009》.pdf

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1、BS EN 1282-2:2005+A1:2009ICS 11.140.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDTracheostomy tubesPart 2: Paediatric tubes (ISO 5366-3:2001, modified)This British Standard was published under the authority of the Standards Policy and Strategy Committee on

2、31 January 2010 BSI 2010ISBN 978 0 580 53770 7Amendments/corrigenda issued since publicationDate CommentsBS EN 1282-2:2005+A1:2009National forewordThis British Standard is the UK implementation of EN 1282-2:2005+A1:2009. It is derived from ISO 5366-3:2001. It supersedes BS EN 1282-2:1997 which is wi

3、thdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted t

4、o Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations 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

5、its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1282-2:2005+A1 August 2009 ICS 11.040.10 Supersedes EN 1282-2:2005English Version Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:20

6、01, modified) Tubes de trachostomie - Partie 2: Tubes pdiatriques (ISO 5366-3:2001, modifie) Tracheotomietuben - Teil 2: Pdiatrische Tuben (ISO 5366-3:2001, gendert) This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1 approved by CEN on 16 July 2009. CEN members are

7、bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to th

8、e 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same

9、status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

10、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved

11、 worldwide for CEN national Members. Ref. No. EN 1282-2:2005+A1:2009: EBS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Size designation and dimensions 6 4.1 Designation of size of tube .6

12、4.2 Outside diameter6 4.3 Length .7 4.4 Angle 8 5 Materials .8 6 Design and finish .8 6.1 Machine end .8 6.2 Paediatric tracheostomy tube connector 8 6.3 Inner tube 9 6.4 Neck-plate 10 6.5 Cuff . 10 6.6 Inflating tubes for cuffs 10 6.7 Patient end . 10 6.8 Introducer 10 7 Requirements for tracheosto

13、my tubes supplied sterile . 11 7.1 Sterility assurance 11 7.2 Packaging for tracheostomy tubes supplied sterile . 11 8 Marking 11 8.1 Marking of tracheostomy tube 11 8.2 Marking of tracheostomy tube connectors 11 8.3 Marking of unit packs . 11 9 Adaptor 13 Annex A (normative) Test for security of at

14、tachment of permanently attached connector, if provided, and neck-plate to tracheostomy tube . 14 A.1 Principle . 14 A.2 Apparatus 14 A.3 Procedure 14 A.4 Expression of results . 15 Annex B (normative) Test method for determining the resting diameter of the cuff 16 B.1 Principle . 16 B.2 Apparatus 1

15、6 B.3 Procedure 16 B.4 Expression of results . 16 Annex C (informative) Guidance on materials and design 17 C.1 Materials 17 C.2 Design 17 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices . 18 Bibliography . 2

16、0 BS EN 1282-2:2005+A1:2009EN 1282-2:2005+A1:2009 (E) 3 Foreword The text of the International Standard ISO 5366-3:2001, including Corrigendum 1:2003 from Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) has been taken

17、 over as a European Standard by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI, with common modifications which are indicated by a straight line in the margin of the text. This European Standard shall be given the status of a national

18、standard, either by publication of an identical text or by endorsement, at the latest by February 2010 and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent righ

19、ts. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1 approved by CEN on 16 July 2009. This document supersedes !EN 1282-2:2005“. The start and finish of text introduced

20、 or altered by amendment is indicated in the text by tags !“. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informativ

21、e Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Fra

22、nce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 4 Introduction ISO 5366 is concerned w

23、ith the basic requirements and method of size designation of tracheostomy tubes made of plastics materials and/or rubber. EN ISO 5366-1 gives requirements for adult tracheostomy tubes made of plastics materials and/or rubber. This document gives requirements for paediatric tracheostomy tubes with an

24、 inside diameter from 2,0 mm to 6,0 mm. Paediatric tracheostomy 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 s

25、ize but especially with regard to airway anatomy and respiratory physiology; 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 document gives some requirements for cuffs, cuffs are seldom provided on th

26、e smaller sizes of paediatric tubes. This document gives requirements for those characteristics of tracheostomy tubes that can be standardized and which are important for patient safety. It does not require the connector to be permanently attached to the tube, as this may be impractical with infants

27、 and small children. Other acceptable methods of connecting these components are available, and this document makes provision for them. This document does not limit the range of tube designs needed to match the variety of paediatric anatomy, lesions and space limitations encountered. The method of d

28、escribing tube dimensions and configuration has been devised with the aim of assisting the clinician in the selection of a suitable tube to conform as far as possible to a particular patients anatomy. Size is designated by inside diameter, which is important because of its relation to resistance to

29、gas flow. Because the stomal and tracheal diameters are important when selecting tubes, it is considered essential that the outside diameter be stated for each size of tube. A tracheostomy tube can increase resistance to gas flow. For tubes with a given outside diameter, differences in wall thicknes

30、s have a major influence on the resistance to gas flow, especially in the smaller sizes of paediatric tracheostomy tubes. Flammability of tracheostomy tubes, for example if flammable anaesthetics, electrosurgical units or lasers are used in oxidant-enriched atmospheres, is a well-recognized hazard1a

31、ddressed by appropriate clinical management, which is outside the scope of this document. 1See ISO/TR 11991. BS EN 1282-2:2005+A1:2009EN 1282-2:2005+A1:2009 (E) 5 1 Scope This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having i

32、nside diameters from 2,0 mm to 6,0 mm. Requirements for paediatric tracheostomy tube connectors and adaptors are also given. This document is not applicable to specialized tracheostomy tubes. 2 Normative references The following referenced documents are indispensable for the application of this docu

33、ment. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556-1:2001, Sterilization of medical devices Requirements for medical devices to be labelled “STERILE” EN ISO 5356-1, Anaesthetic a

34、nd respiratory equipment Conical connectors Part 1: Cones and sockets (ISO 5356-1:2004) EN ISO 5366-1:2004, Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evalu

35、ation and testing (ISO 10933-1:2003) EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 5361, Anaesthetic and respiratory equipment Tracheal tubes and connectors ISO 11607, Packaging for terminally sterilize

36、d medical devices 3 Terms and definitions For the purposes of this European Standard, the terms and definitions given in EN ISO 5366-1:2004 and the following apply. 3.1 paediatric tracheostomy tube tube designed for insertion into the trachea of an infant or child through a tracheostomy 3.2 paediatr

37、ic tracheostomy tube connector tubular component which fits directly into the paediatric tracheostomy tube 3.3 machine end (paediatric tracheostomy tube connector) end of the component nearest the machine which is intended to mate with the breathing system of an anaesthetic machine or lung ventilato

38、r 3.4 patient end (paediatric tracheostomy tube connector) end of the component nearest the patient which is inserted into the paediatric tracheostomy tube BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 6 3.5 adaptor specialized connector to establish functional continuity between otherwise di

39、sparate or incompatible components 4 Size designation and dimensions 4.1 Designation of size of tube 4.1.1 The size of a tracheostomy tube (outer tube) shall be designated by the nominal inside diameter (ID) of the tube expressed in millimetres, as measured at the minimum diameter, in accordance wit

40、h Table 1, excluding any encroachment allowed by 6.6.1. 4.1.2 For tracheostomy tubes provided with an inner tube to which is attached an 8,5 mm or 15 mm male conical connector complying with the requirements of EN ISO 5356-1 see 6.1 a), the size shall be designated by the nominal inside diameter (ID

41、) of the inner tube expressed in millimetres in accordance with Table 1. Table 1 Size designation, inside diameter and tolerances of paediatric tracheostomy tubes Dimensions in millimetresDesignated size Inside diameter Tolerance 2,0 2,0 +0,2 0 2,5 2,5 3,0 3,0 3,5 3,5 4,0 4,0 4,5 4,5 + 0,3 0 5,0 5,0

42、 5,5 5,5 6,0 6,0 4.2 Outside diameter 4.2.1 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 0,1 mm. NOTE The marked outside diameter relates to that portion of the tube intended to be withi

43、n the 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 outside diameter subject to a tolerance of 0,2 mm. 4.2.3 The actual outside diameter of section C shall be the marked outside diameter subject to a tolerance o

44、f 0,5 mm. BS EN 1282-2:2005+A1:2009EN 1282-2:2005+A1:2009 (E) 7 a) Paediatric tracheostomy tube b) Patient end Key 1 Neck-plate 2 Datum plane 3 Tip rounded 4 Bevel, if present aObtuse angle formed between the long axes of the tube at the machine and patient ends. Figure 1 Basic dimensions of paediat

45、ric tracheostomy tubes 4.3 Length 4.3.1 The nominal length (l1 + l2+ l3in Figure 1) shall be measured from the patient side of the neck-plate to the patient end, including the bevel if present (see Figure 1), and expressed in millimetres. 4.3.2 The actual nominal length (l1 + l2+ l3 in Figure 1) sha

46、ll be the marked nominal length subject to a tolerance of 1,5 mm for tubes with a marked inside diameter of less than 4,5 mm, or subject to a tolerance of 2 mm for tubes with a marked inside diameter of 4,5 mm or greater. BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 8 4.3.3 For tubes with an

47、 adjustable neck-plate, the range of measurements for nominal length (see Figure 1) shall be expressed in millimetres. 4.3.4 Dimensions l1, l2 and l3shall be expressed in millimetres see Figure 1 a). NOTE Dimensions l1and/or l2can be, or approach, zero. 4.4 Angle The angle (see Figure 1) shall be ex

48、pressed in degrees. 5 Materials Tracheostomy tubes, including cuffs and tracheostomy tube connectors provided with the tube, in their ready-for-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in EN ISO 10993-1

49、. !NOTE 1“ See Annex C for guidance on materials and design. !If phthalates are incorporated in parts of the medical devices coming directly or indirectly into contact with the patient the medical device shall be labelled accordingly. NOTE 2 Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction.“ 6 Design and finish 6.1 Machine end The machine end of a paediatric tracheostomy tube shall a) have a permanently attached 8,5 mm or 15 mm male conical connector complying with the requirements of EN ISO