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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1282-2 : 1997 The E
2、uropean Standard EN 1282-2 : 1997 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Tracheostomy tubes Part 2. Paediatric tubes Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (
3、c) BSI BS EN 1282-2 : 1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1997 BSI 1997 The following BSI references relate to the work on this stand
4、ard: Committee reference CH/45 Draft for comment 93/505405 DC ISBN 0 580 27916 2 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/45, Tracheal tubes and rela
5、ted equipment, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries British Anaesthetic and Respiratory Equipment Manufacturers Association British Paediatric Association British Surgical Trades Asso
6、ciation Department of Health Medical Sterile Products Association National Association of Theatre Nurses Royal College of Paediatrics and Child Health Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1282-2 : 1997 BSI 1997i Contents Pag
7、e Committees responsibleInside front cover National forewordii Foreword2 Text of EN 1282-23 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1282-2 : 1997 National foreword This British Standard has been prepared by Technica
8、l Committee CH/45 and is the English language version of EN 1282-2 Tracheostomy tubes Part 2 : Paediatric tubes, published by the European Committee for Standardization (CEN). Attention is drawn to BS EN 1282-1 : 1997, which gives requirements for tracheostomy tubes for use with adults, which supers
9、edes BS 6149 : Part 1 : 1987 and Part 2 : 1993. Cross-references Publication referred toCorresponding British Standard EN 556BS EN 556 : 1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled Sterile EN 980BS EN 980 : 1997 Graphical symbols for use in th
10、e labelling of medical devices prEN 1281-1BS EN 1281-1 Anaesthetic and respiratory equipment. Conical connectors Part 1 : 1997 Cones and sockets EN 1282-1 : 1996BS EN 1282 Tracheostomy tubes Part 1 : 1997 Tubes for use with adults EN 20594-1BS EN 20594 Conical fittings with a 6 % (Luer) taper for sy
11、ringes, needles and certain other medical equipment Part 1 : 1994 General requirements EN 30993-1BS EN 30993 Biological evaluation of medical devices Part 1 : 1994 Guidance on selection of tests The Technical Committee has reviewed the provisions of prEN 868-1 and prEN 1782 to which reference is mad
12、e in the text, and has decided that they are acceptable for use in conjunction with this British Standard. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the
13、EN title page, pages 2 to 12, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secr
14、etariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. EN 1282-2 : 1997 E EUROPEAN STANDARDEN 1282-2 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.040.10 Descriptors: Medical equipment, anaesthetic equipment, artificial breathing apparatus, babies, ch
15、ildren, tracheostomy tubes, plastic tubes, rubber hoses, dimensions, designation, design, tests, packing, marking English version Tracheostomy tubes Part2: Paediatric tubes Tubes de trache ostomie Partie 2: Tubes pe diatriques Tracheotomietuben Teil 2: Pa diatrische Tuben This European Standard was
16、approved by CEN on 1997-01-27. 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
17、 standards may be obtained on application to the Central Secretariat 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 notifi
18、ed to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
19、 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 1282-2 : 1997 BSI 1997 Foreword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, the secretariat of which is held by
20、 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 August 1997, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard has been prepared under
21、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 informative annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regula
22、tions, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Th
23、is European Standard applies to tracheostomy tubes and has been prepared in two Parts. This Part addresses tubes for paediatric use; Part 1 specifies requirements for tracheostomy tubes with an inside diameter of 6,5 mm or greater for adult use. This Part of this European Standard differs from Part
24、1 in that it does not require the connector to be permanently attached to the tube. Annexes A and B are normative and form part of this European Standard. Annexes C, D and ZA are for information only. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions4 4Size designatio
25、n and dimensions4 5Materials4 6Design and finish4 7Requirements for tracheostomy tubes supplied sterile6 8Marking6 Annexes A(normative) Method for the security of attachment of permanently attached connector, if provided, and neck-plate to tracheostomy tube8 B(normative) Method for determining the r
26、esting diameter of the cuff8 C(informative) Guidance on materials and design8 D(informative) Bibliography9 ZA(informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives10 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00
27、:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1282-2 : 1997 BSI 1997 1) See ISO/TR 11991. Introduction This European Standard is concerned with the basic requirements and method of size designation of tracheostomy tubes made of plastics materials and/or rubber. This Part of this European Standard s
28、pecifies 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 t
29、herapy. 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 Part of this
30、 European Standard specifies some requirements for cuffs, cuffs are seldom provided on the smaller sizes of paediatric tubes. This Part of this European Standard specifies requirements for those characteristics of tracheostomy tubes that can be standardized and which are important for patient safety
31、. 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 standard makes provision for them. This Part of this European Standard does not limit
32、 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 possib
33、le to a particular patients 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 should be stated for ea
34、ch size of tube. A tracheostomy tube may 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,
35、 for example if flammable anaesthetics, electrosurgical units or lasers are used in oxidant-enriched atmospheres, is a well-recognized hazard1)which is addressed by appropriate clinical management, which is outside the scope of this standard. 1 Scope This Part of this European Standard specifies req
36、uirements 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 specified. Specialized tracheostomy tubes are excluded from the Scope of this standard. 2
37、 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisio
38、ns of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 556Sterilization of medical devices Requirements for medical devices to be labelled STERILE prEN
39、 868-1Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods EN 980Terminology, symbols and information provided with medical devices Graphical symbols for use in the labelling of medical devices prEN 1281-1Anaesthetic and respira
40、tory equipment Conical connectors Part 1: Cones and sockets EN 1282-1 : 1996Tracheostomy tubes Part 1: Tubes for use in adults prEN 1782Tracheal tubes and connectors EN 20594-1 : 1993Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General r
41、equirements (ISO 594-1 : 1986) EN 30993-1Biological evaluation of medical devices Part 1: Guidance on selection of tests (ISO 10993-1 : 1992 + Technical Corrigendum 1 : 1992) Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1282-2 :
42、 1997 BSI 1997 3 Definitions For the purposes of this Part of the standard, the definitions given in EN 1282-1, together with the following definitions, apply. 3.1 paediatric tracheostomy tube Tube designed for insertion into the trachea of an infant or child through a tracheostomy. 3.2 paediatric t
43、racheostomy tube connector Tubular component which fits directly into the paediatric tracheostomy tube. 3.3 machine end of 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.
44、 3.4 patient end of paediatric tracheostomy tube connector End of the component nearest the patient which is inserted into the paediatric tracheostomy tube. 3.5 adaptor Specialized connector to establish functional continuity between otherwise disparate or incompatible components. 4 Size designation
45、 and dimensions 4.1 Designation of the 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
46、6.7.1. 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 prEN 1281-1 (see 6.1a), the size shall be designated by the nominal inside diameter (ID) of the inner tube expressed in millimetres in acc
47、ordance with table 1. Table 1. Size designation, inside diameter and tolerances of paediatric tracheostomy tubes Dimensions in millimetres Designated sizeInside diameter and tolerance 2,0 2,0 0 +0,2 2,5 2,5 0 +0,2 3,0 3,0 0 +0,2 3,5 3,5 0 +0,2 4,0 4,0 0 +0,2 4.5 4,5 0 +0,3 5,0 5,0 0 +0,3 5,5 5,5 0 +
48、0,3 6,0 6,0 0 +0,3 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 wi
49、thin 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 of0,2 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. 4.3 Length 4.3.1 The centre-line length (dimension A + B + C 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.
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