Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BRITISH STANDARD Tracheostomy tubes Part 2: Paediatric tubes (ISO 5366-3:2001, modified) ICS 11.140.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 1282-2:2005 +A1:2009 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 National foreword This 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UK implementation of EN 1282-2:2005+A1:2009 It is derived from ISO 5366-3:2001 It supersedes BS EN 1282-2:1997 which is withdrawn The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the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 to 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 its correct application Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2010 Amendments/corrigenda issued since publication Date Comments © BSI 2010 ISBN 978 580 53770 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 1282-2:2005+A1 NORME EUROPÉENNE EUROPÄISCHE NORM August 2009 ICS 11.040.10 Supersedes EN 1282-2:2005 English Version Tracheostomy tubes - Part 2: Paediatric tubes (ISO 53663:2001, modified) Tubes de trachéostomie - Partie 2: Tubes pédiatriques (ISO 5366-3:2001, modifiée) Tracheotomietuben - Teil 2: Pädiatrische Tuben (ISO 53663:2001, geändert) This European Standard was approved by CEN on 25 April 2005 and includes Amendment approved by CEN on 16 July 2009 CEN members are 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 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 1282-2:2005+A1:2009: E Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions 4.1 4.2 4.3 4.4 Size designation and dimensions Designation of size of tube Outside diameter Length .7 Angle θ Materials 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 Design and finish Machine end Paediatric tracheostomy tube connector Inner tube Neck-plate 10 Cuff 10 Inflating tubes for cuffs 10 Patient end 10 Introducer 10 7.1 7.2 Requirements for tracheostomy tubes supplied sterile 11 Sterility assurance 11 Packaging for tracheostomy tubes supplied sterile 11 8.1 8.2 8.3 Marking 11 Marking of tracheostomy tube 11 Marking of tracheostomy tube connectors 11 Marking of unit packs 11 Adaptor 13 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Annex A (normative) Test for security of attachment 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 16 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 20 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 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 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 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 rights 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 approved by CEN on 16 July 2009 This document supersedes !EN 1282-2:2005" The start and finish of text introduced 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) ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ For relationship with EU Directive(s), see informative 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Introduction ISO 5366 is concerned with 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 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 size 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 the 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 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 describing 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 patient's anatomy Size is designated by inside diameter, which is important because of its relation to resistance to 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 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ A tracheostomy tube can increase resistance to gas flow For tubes with a given outside diameter, differences in wall thickness 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 hazard addressed by appropriate clinical management, which is outside the scope of this document 1See ISO/TR 11991 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Scope This European Standard specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside 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 Normative references The following referenced documents are indispensable for the application of this document 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 and 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: Evaluation and testing (ISO 10933-1:2003) EN 20594-1, Conical fittings with a % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ ISO 5361, Anaesthetic and respiratory equipment — Tracheal tubes and connectors ISO 11607, Packaging for terminally sterilized medical devices 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 paediatric 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 ventilator 3.4 patient end (paediatric tracheostomy tube connector) end of the component nearest the patient which is inserted into the paediatric tracheostomy tube Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 3.5 adaptor specialized connector to establish functional continuity between otherwise disparate or incompatible components 4.1 Size designation and dimensions 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 with 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) of the inner tube expressed in millimetres in accordance with Table Table — Size designation, inside diameter and tolerances of paediatric tracheostomy tubes Dimensions in millimetres Designated size Inside diameter 2,0 2,0 2,5 2,5 Tolerance 3,5 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 4,0 4,0 4,5 4,5 5,0 5,0 + 0,3 5,5 5,5 6,0 6,0 +0,2 3,0 4.2 3,0 3,5 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 within 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 of ± 0,5 mm 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) a) Paediatric tracheostomy tube ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ b) Patient end Key Neck-plate Datum plane Tip rounded Bevel, if present a Obtuse angle formed between the long axes of the tube at the machine and patient ends Figure — Basic dimensions of paediatric tracheostomy tubes 4.3 Length 4.3.1 The nominal length (l1 + l2 + l3 in 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) shall 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 ± mm for tubes with a marked inside diameter of 4,5 mm or greater Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 4.3.3 For tubes with an 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 l3 shall be expressed in millimetres [see Figure a)] NOTE Dimensions l1 and/or l2 can be, or approach, zero 4.4 Angle θ The angle θ (see Figure 1) shall be expressed in degrees Materials Tracheostomy tubes, including cuffs and tracheostomy tube connectors provided with the tube, in their ready-foruse state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in EN ISO 10993-1 !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 Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction." 6.1 Design and finish Machine end ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 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 5356-1, or NOTE In this context, permanently attached means it does not become detached when subject to the forces described in the test method given in Annex A b) accept a paediatric tracheostomy tube connector in accordance with 6.2 or c) mate with an adaptor in accordance with Clause 6.2 Paediatric tracheostomy tube connector 6.2.1 The nominal size of a paediatric tracheostomy tube connector shall be designated by its inside diameter in accordance with Table NOTE A connector is intended to fit a tracheostomy tube of the same designated size 6.2.2 The connector supplied with a tracheostomy tube shall have an inside diameter not less than the inside diameter of that tube as stated by the manufacturer [see 8.1 a)] 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Table — Size designation, inside diameter and tolerances of paediatric tracheostomy tube connectors Dimensions in millimetres Designated size Inside diameter of patient end ± 0,15 2,0 2,0 2,5 2,5 3,0 3,0 3,5 3,5 4,0 4,0 4,5 4,5 5,0 5,0 5,5 5,5 6,0 6,0 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 6.2.3 The machine end shall be an 8,5 mm or 15 mm male conical connector complying with EN ISO 5356-1 The inside diameter of the conical connector at the machine end shall be not less than that allowed by Table for the patient end 6.2.4 Any transition from one inside diameter to another shall be tapered to give an adequate lead-in for passage of a suction catheter !6.2.5 The manufacturer shall address in a usability engineering process the risk resulting from poor usability (see IEC 60601-1-6 / 62366) Check compliance by inspection of the usability engineering file 6.2.6 A clinical evaluation shall be performed and documented in the risk management file Check compliance by inspection of the risk management file 6.2.7 Where appropriate, validated biophysical or modelling research shall be carried out Check compliance by inspection of the technical file." 6.3 Inner tube 6.3.1 The inner tube, if provided with the outer tube, shall extend to within 1,0 mm of the patient end of the tracheostomy (outer) tube and not more than 1,0 mm beyond the patient end 6.3.2 The machine end of the inner tube shall either comply with 6.1 or shall not prevent the tracheostomy (outer) tube connector or adaptor, if provided, mating with the breathing system of an anaesthetic machine or lung ventilator Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 6.4 Neck-plate 6.4.1 tube Tracheostomy tubes shall have a neck-plate that shall be either adjustable or permanently attached to the 6.4.2 The neck-plate shall be provided with holes or other means to permit attachment to the patient 6.4.3 If a tracheostomy tube has an adjustable neck-plate, it shall be securable to the tube (but see C.2.4) 6.4.4 When tested in accordance with Annex A, the neck-plate shall not move longitudinally relative to the tube 6.5 Cuff 6.5.1 A cuff, if provided, shall be permanently attached to the tube 6.5.2 Cuffs of tracheostomy tubes shall satisfy the requirements of ISO 5361 6.5.3 The cuff resting diameter shall be within ± 15 % of the marked value [see 8.3.2 m)] when determined in accordance with Annex B 6.6 Inflating tubes for cuffs 6.6.1 Inflating tubes The inflating tube, if fitted, shall have an outside diameter of not more than 2,5 mm The wall around the inflation lumen shall not encroach on the lumen of the tracheostomy tube by more than 10 % of the inside diameter of the tracheostomy tube ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ The intentional deflation of the cuff shall not be prevented by the inflating tube, inflating valve or any closure device 6.6.2 Pilot balloon The inflating tube shall have a pilot balloon and/or other device to indicate inflation/deflation of the cuff NOTE This (these) device(s) can also serve as a pressure-indicating or -limiting device 6.6.3 Free end of inflating tubes for cuffs The end of the inflating tube shall be either open or sealed with a closure device or inflation valve, but in all instances it shall be capable of accepting a male conical fitting with a % taper (Luer), complying with the requirements specified in EN 20594-1 The length [see Figure a), dimension l1 of EN ISO 5366-1:2004] of the free end of the inflating tube shall be not less than 40 mm unless an inflation valve or closure device is provided If an inflation valve or closure device is provided, the length [see Figure b), dimension l2 of EN ISO 5366-1:2004] between the pilot balloon (or other device) and the female fitting which accepts a male Luer conical fitting shall be not less than 10 mm unless the pilot balloon and valve or closure device are integral NOTE This is to facilitate clamping of the inflating tube 6.7 Patient end If a bevel is present, the angle of the bevel β shall be not less than 50º [see Figure b)] 6.8 Introducer If provided, the introducer, when correctly seated, shall not fall out of the paediatric tracheostomy tube under its own weight when the tube is held by the neck-plate with the patient end uppermost 10 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) The introducer should be freely removable in use Requirements for tracheostomy tubes supplied sterile 7.1 Sterility assurance Tracheostomy tubes supplied and marked “STERILE” shall satisfy the requirements of 4.1 of EN 556-1:2001 7.2 Packaging for tracheostomy tubes supplied sterile 7.2.1 The following information shall be apparent on visual examination of the intact unit container: a) the size and pre-formed shape of the tube; b) whether a cuff is provided; c) whether a connector or adaptor is provided NOTE For example, the unit container can be transparent and the tube visible, or a drawing to scale (preferably full-scale) can be used 7.2.2 Each tracheostomy tube supplied and marked “STERILE” shall be contained in a unit container The container shall serve as an effective barrier to the penetration of microorganisms and particulate material, in accordance with ISO 11607 The pack shall permit the aseptic extraction of the contents and shall not be capable of re-closure without clearly revealing that it has been opened Marking 8.1 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Marking of tracheostomy tube The following information shall be marked on the neck-plate and/or tube and shall be visible from the machine end of the tube: a) the designated size (nominal inside diameter) expressed in millimetres in accordance with 4.1; b) the nominal outside diameter expressed in millimetres in accordance with 4.2; c) the name and/or trade mark of the manufacturer 8.2 Marking of tracheostomy tube connectors The tracheostomy tube connector, if not permanently attached to the tracheostomy tube, shall be marked with its designated size (see 6.2.1) 8.3 8.3.1 Marking of unit packs General Marking of unit packs and of shelf or multi-packs and information to be supplied by the manufacturer should comply with EN 1041 The requirements of 8.3.2 and 8.3.3 may be met by use of appropriate symbols as given in EN 980 !For single use devices the manufacturer shall disclose in the instructions for use or upon request the risks associated with reuse." 11 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 8.3.2 Marking of tracheostomy tube unit packs Unit containers or a package insert shall be clearly marked to indicate the following: a) a description of contents; b) the designated size, expressed in millimetres in accordance with 4.1; c) the nominal outside diameter, expressed in millimetres (see 4.2); d) the nominal length, expressed in millimetres (see 4.3.1) For tubes with an adjustable neck-plate, the range of nominal lengths shall be given; e) if a connector or adaptor (see 6.1) is not provided, a statement to this effect shall be marked on the unit container; f) dimension A as shown in Figure 1; for tubes with a fixed neck-plate, dimension B; for tubes with an adjustable neck-plate, the maximum dimension B; g) the angle θ in accordance with 4.4; h) the name and/or trademark of the manufacturer and/or supplier; !in addition, the name and address of the authorized representative if the manufacturer does not have a registered place of business in the Community;" i) the batch number; ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ j) unless the tracheostomy tube is intended and marked as being for single use, instructions for cleaning and disinfection or sterilization; k) the word “STERILE” if appropriate (see EN 1041); l) for tubes not intended for re-use, the words “single use” or equivalent; !NOTE The attention of manufacturers is drawn to consistent use of indication across the Community for single use devices." m) for cuffed tubes, the resting diameter of the cuff, determined in accordance with Annex B and expressed in millimetres to two significant figures; n) if an inner tube is provided in the unit container, the nominal inside diameter of the inner tube; o) the presence of natural rubber (latex), if present in the device It is strongly recommended that the use-by date be given 8.3.3 Marking of inner tube unit packs Inner tube unit packs shall be clearly marked to indicate the following: a) a description of contents; b) the designated size (nominal inside diameter) of the tracheostomy tube (outer tube) into which it is designed to fit; c) the nominal inside diameter of the inner tube; d) the name and/or trademark of the manufacturer and/or supplier; 12 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) e) the batch number; f) unless the tracheostomy tube is intended and marked as being for single use, instructions for cleaning and disinfection or sterilization; g) the word “STERILE” if appropriate (see EN 1041); h) for inner tubes not intended for re-use, the words “single use”, or equivalent; i) the presence of natural rubber (latex), if present in the device It is strongly recommended that the use-by date be given Adaptor 9.1 If supplied with the tube (see 6.1 c)), the adaptor shall have at its machine end an 8,5 mm or 15 mm male conical connector complying with the requirements of EN ISO 5356-1 9.2 Any transition from one inside diameter to another shall be tapered to give an adequate lead-in for passage of a suction catheter 9.3 The adaptor shall have an inside diameter not less than that given in Table for the patient end of the connector of the same designated size as that of the tube as stated by the manufacturer (see 8.1 a)) ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 13 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Annex A (normative) Test for security of attachment of permanently attached connector, if provided, and neck-plate to tracheostomy tube A.1 Principle The security of attachment of the neck-plate to the tracheostomy tube is tested by applying an axial separation force to the tube, relative to the neck-plate If a permanently attached connector is provided, the security of attachment to the tracheostomy tube is tested by applying an axial separation force to the tube, relative to the connector A.2 Apparatus A.2.1 24 h Means of conditioning the tracheostomy tube at (37 ± 2) ºC at not less than 80 % relative humidity for A.2.2 Means of securing the connector, if provided, and the tracheostomy tube and applying an axial -1 separation force of (50 ± 5) N at a rate of (50 ± 5) mm·min ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ A.2.3 Means of securing the neck-plate and the tracheostomy tube and applying an axial separation force of -1 (15 ± 1,5) N or (50 ± 5) N at a rate of (50 ± 5) mm·min A.3 Procedure A.3.1 Condition the tracheostomy tube at (37 ± 2) ºC at not less than 80 % relative humidity for 24 h A.3.2 Remove the tracheostomy tube from the conditioning chamber and separately secure the connector and tracheostomy tube (A.2.2) NOTE For tracheostomy tubes with the conical connector permanently attached to the inner tube, the mechanism which secures the inner tube within the outer (tracheostomy) tube should first be engaged in accordance with manufacturers' instructions before securing the connector and tracheostomy tube A.3.3 Within 10 of removing the tracheostomy tube from the conditioning chamber, apply an axial separation -1 force of (50 ± 5) N to the tracheostomy tube, relative to the connector at a rate of (50 ± 5) mm·min A.3.4 Having already removed the tracheostomy tube from the conditioning chamber, secure the neck-plate and tracheostomy tube (A.2.3) A.3.5 Within 10 of removing the tracheostomy tube from the conditioning chamber, apply an axial separation force to the tracheostomy tube, relative to the neck-plate as follows: a) for tracheostomy tubes with an adjustable neck-plate, apply an axial force of (15 ± 1,5) N at a rate of -1 (50 ± 5) mm·min ; b) for tracheostomy tubes with a permanently attached neck-plate, apply an axial force of (50 ± 5) N at a rate of -1 (50 ± 5) mm·min 14 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) A.4 Expression of results Record whether or not the connector, if provided, or neck-plate moves longitudinally relative to the tracheostomy tube ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 15 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Annex B (normative) Test method for determining the resting diameter of the cuff B.1 Principle The resting diameter of the cuff is measured when the cuff is inflated with a pressure which is intended to remove creases but to minimize stretching of its walls B.2 Apparatus B.2.1 Means to inflate the cuff with sufficient air to create an internal overpressure of 2,0 kPa ± % B.3 Procedure B.3.1 Inflate the cuff with sufficient air to create an internal overpressure of 2,0 kPa ± % and leave to stabilize for at (23 ± 2) ºC, at not less than 80 % relative humidity, maintaining that overpressure B.3.2 Locate the plane of maximum cuff diameters perpendicular to the axis of the tube Measure the four cuff diameters at intervals of 45º in the located plane ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ B.4 Expression of results Calculate the arithmetic mean of the measurements obtained in B.3.2 and express the result in millimetres 16 标准分享网 www.bzfxw.com 免费下载 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) Annex C (informative) Guidance on materials and design C.1 Materials C.1.1 The materials used for the manufacture of the tubes should have sufficient rigidity to allow the construction of a tube with the thinnest possible wall which, at the same time, maintains resistance to kinking When in place it should be flexible and soft enough to conform to the patient's anatomy without exerting undue pressure on the body tissues C.1.2 Unless intended and marked for single use, tracheostomy tubes should be reasonably resistant to deterioration by methods of cleaning, disinfection and sterilization as recommended by the manufacturer Such tubes should withstand accepted methods of steam sterilization The recommended method or methods of sterilization should not produce changes in the tube material which will compromise the biological safety of the tracheostomy tube (see Clause 5) C.1.3 Tracheostomy tubes under normal conditions of use should be reasonably resistant to deterioration by clinically used concentrations of anaesthetic vapours and gases ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ C.1.4 Tracheostomy tubes should be readily detectable by X-ray either by the nature of the material of which they are made or by the provision of a marker at the patient end C.1.5 When not in use the tracheostomy tube should maintain its intended shape when stored in accordance with the manufacturer's instructions C.2 Design C.2.1 Tracheostomy tubes, including the neck-plate, should have smooth external and internal surfaces The cuff should have a smooth surface C.2.2 The patient end of the tracheostomy tube should be free from sharp edges C.2.3 neck The neck-plate should be rounded at the edges, and its shape should adapt to the contour of the patient's C.2.4 For tracheostomy tubes with an adjustable neck-plate, use of the mechanism for securing the neck-plate should not cause a significant reduction of the inside diameter of the tube C.2.5 A retaining or latching device can be incorporated in the design to provide added security of attachment of the conical connectors Such a device can, however, introduce other hazards such as accidental extubation It should, therefore, be as light and compact as possible Any projections (for example hooks, lugs or studs) should be designed so as to minimize the risk of catching on surgical dressings or other equipment 17 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 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 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 Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA 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 — Correspondence between this European Standard and Directive 93/42/EEC Medical devices Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes EN of Directive 93/42/EEC 1, 2, 1, 2, 3, 7.1, 7.2 !5 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 7.5 (1st paragraph) 7.5 (2nd paragraph) 1, 2, 3, 9.2 6.1 4, 7.5, 9.1, 9.3 6.2 9.1, 9.3 !6.2.5 " (2nd paragraph, 1st dash) 6.2.6 (2nd paragraph, 2nd dash) 6a) 6.2.7 7.1 (3rd dash) 6.3 9.1, 9.3 6.4 6.5.1 6.5.2 6.6 6.6.3 9.1 6.8 1, 2, 18 标准分享网 www.bzfxw.com 免费下载 " Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 7.1 8.1, 8.3, 8.4 7.2.2 5, 8.1, 8.3 1, 2, 8.1 13.1 8.1 a) 13.3 b) 8.1 b) 2, 13.3 b) 8.1 c) 13.3 a) 8.2 13.1, 13.3 b) 8.3 13.1 8.3.1 13.2, 13.3 g), h), i), j), k), l), m), 13.4 !8.3.1 13.6 (h) (2nd paragraph) 8.3.2 13.3 e) 8.3.2 a) 13.3 b), 13.4 8.3.2 b) 13.3 b) 8.3.2 c) 13.3b) 8.3.2 d) 13.3 b) 8.3.2 e) 13.3 b) 8.3.2 f) 13.3 b) 8.3.2 g) 13.3 b) 8.3.2 h) 13.3 a) 8.3.2 i) 13.3 d), 13.5 8.3.2 j) 8.6 8.3.2 k) 8.1, 8.3, 8.7, 13.2, 13.3 b), 13.3 c) 8.3.2 l) 13.3 b), 13.3 f) 8.3.2 m) 13.3 b) 8.3.2 o) 7.1 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) 2, 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 8.3.3 g) 8.1, 8.3, 8.7, 13.2, 13.3 b), 13.3 c) " 19 Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005+A1:2009 EN 1282-2:2005+A1:2009 (E) 8.3.3 h) 13.3 b), 13.3 f) 8.3.3 i) 7.1 9.1, 9.3 WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard Bibliography [1] ISO 4135, Anaesthetic and respiratory equipment — Vocabulary [2] ISO/TR 11991, Guidance on airway management during laser surgery of upper airway [3] EN 980, Graphical symbols for use in the labelling of medical devices [4] EN 1041, Information supplied by the manufacturer with medical devices 20 标准分享网 www.bzfxw.com 免费下载 This page has been intentionally left blank Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI Licensed Copy: athen reading, Reading University Library, 31/01/2010 05:17, Uncontrolled Copy, (c) BSI BS EN 1282-2:2005 +A1:2009 BSI - 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