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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1282-1 : 1997 The E
2、uropean Standard EN 1282-1 : 1996 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Anaesthetic and respiratory equipment Tracheostomy tubes Part 1. Tubes for use in adults Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28
3、05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1282-1 : 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 May 1997 BSI 1997 The following BSI
4、 references relate to the work on this standard: Committee reference CH/45 Draft for comment 93/509494 DC ISBN 0 580 27119 6 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Techni
5、cal Committee CH/45, Tracheal tubes and related 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 Paediat
6、ric Association British Surgical Trades Association Department of Health Medical Sterile Products Association National Association of Theatre Nurses Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1282-1 : 1997 BSI 1997i Contents Page
7、Committees responsibleInside front cover National forewordii Foreword2 Text of EN 1282-13 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1282-1 : 1997 National foreword This British Standard has been prepared by Technical
8、Committee CH/45 and is the English language version of EN 1282-1 : 1996 Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes for use in adults published by the European Committee for Standardization (CEN). It supersedes BS 6149 : Part 1 : 1987 and BS 6149 : Part 2 : 1993, which are
9、 withdrawn. BS 6149 was originally published in two parts, Part 1 covering connectors and Part 2 covering tracheostomy tubes for use in adults. This revision will also comprise two Parts, Part 1 covering tubes for use in adults and Part 2 covering tubes for paediatric use, each Part incorporating sp
10、ecifications for the relevant connectors. EN 1282-2, for paediatric tubes, is in preparation and, when published, will be implemented as BS EN 1282-2. Cross-references Publication referred toCorresponding British Standard EN 556 : 1994BS EN 556 : 1995 Sterilization of medical devices. Requirements f
11、or terminally-sterilized devices to be labelled Sterile EN 980 : 1996BS EN 980 : 1997 Graphical symbols for use in the labelling of medical devices EN 20594-1 : 1993BS EN 20594 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1 : 1994 General requ
12、irements EN 30993-1 : 1993BS EN 30993 Biological evaluation of medical devices Part 1 : 1994 Guidance on selection of tests 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, pag
13、es i and ii, an EN title page, pages 2 to 12, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Norm
14、ung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN members Ref. No. EN 1282-1 : 1996 E EUROPEAN STANDARDEN 1282-1 NORME EUROPE ENNE EUROPA ISCHE NORM October 1996 ICS 11.040.10 Descriptors: medical equipment, anaesthetic equipment, artificial breathing appara
15、tus, tracheostomy tubes, plastic tubes, rubber tubes, specifications, dimensions, designation, design, tests, marking, packing, labelling English version Anaesthetic and respiratory equipment Tracheostomy tubes Part1: Tubes for use in adults Mate riel respiratoire et danesthe sie Tubes de trache ost
16、omie Partie 1: Tubes pour adultes Ana sthesie- und Beatmungsgera te Tracheotomietuben Teil 1: Tuben zur Anwendung bei Erwachsenen This European Standard was approved by CEN on 1996-10-04. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giv
17、ing 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 Central Secretariat or to any CEN member. This European Standard exists in three official vers
18、ions (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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,
19、Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 1282-1 : 1996 BSI 1997 Fo
20、reword This European Standard has been prepared by Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, 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
21、 the latest by April 1997, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard is based on ISO 5366-1 : 1986, Tracheostomy tubes Part 1: Connectors, and ISO 5366-2 : 1985 Tracheostomy tubes Part 2: Basic requirements. It is one of two parts dealin
22、g with tracheostomy tubes and connectors. EN 1282-2 specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports
23、 essential requirements of EU Directive(s). For relationship with EU Directives, see informative annex ZA, which is an integral part of this standard. Annexes A and B are normative and form part of this European Standard. Annexes C, D and ZA are for information only. According to the CEN/CENELEC Int
24、ernal Regulations, 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
25、 Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Size designation and dimensions6 5Materials6 6Design and finish6 7Requirements for tracheostomy tubes supplied sterile7 8Marking and labelling7 Annexes A(normative) Test method for the security of attachmen
26、t of connector and neck-plate to tracheostomy tube9 B(normative) Test method for determining the resting diameter of the cuff9 C(informative) Guidance on materials and design9 D(informative) Bibliography10 ZA(informative) Clauses of this European Standard addressing essential requirements or other p
27、rovisions of EU Directives11 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1282-1 : 1996 BSI 1997 1)See ISO/TR 11991. Introduction EN 1282-1 is one of a series dealing with anaesthetic equipment and lung ventilators, and is conce
28、rned with the basic requirements and method of size designation of tracheostomy tubes made of plastics materials and/or rubber. Specialized tubes, for example those without a connector at the machine end intended for spontaneously breathing patients, and those with reinforced walls or tubes made of
29、metal are excluded from the scope of this European Standard. This Part of EN 1282 specifies requirements for tracheostomy tubes with an inside diameter of 6,5 mm or greater. EN 1282-2 specifies requirements for tracheostomy tubes with an inside diameter from 2,0 to 6,0 mm for paediatric use. The met
30、hod 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 patients anatomy. Size is designated by inside diameter, which is important because of its relation to resist
31、ance to gas flow. Because the stomal and tracheal diameters are important when selecting tubes, it was considered essential that the outside diameter should be stated for each size of tube. Cuffed tracheostomy tubes can be characterized by a combination of the tube inside and outside diameters and b
32、y the cuff resting diameter. The relationship of cuff and tracheal diameters dictates the intra-cuff pressures required to provide a seal. Excessive pressure on the tracheal wall can obstruct capillary blood flow. A range of cuff designs is available to meet the particular clinical requirements. Thi
33、s Part of EN 1282 requires that the resting diameter of the cuff is marked on the unit package as this information allows the clinician to match the product to the application. A 15 mm male conical connector in accordance with prEN 1281-1 should be used for tracheostomy tubes, as for tracheal tubes,
34、 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 inadvertent disconnection of the connector from the tube. Flammability of tracheostomy tubes, for example if
35、flammable anaesthetics, electrosurgical units, or lasers are used in oxidant-enriched atmospheres, is a well-recognized hazard1)that is addressed by appropriate clinical management, and is outside the scope of this standard. 1 Scope This Part of EN 1282 specifies requirements for tracheostomy tubes
36、made of plastics materials and/or rubber having inside diameters of 6,5 mm or greater. Such tubes are primarily designed for patients who require anaesthesia, artificial ventilation or other respiratory support, but need not be restricted to these uses. This standard does not apply to specialized tu
37、bes. 2 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 r
38、evisions 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 556 : 1994Sterilization of medical devices Requirements for medical devices to be labelled
39、 STERILE prEN 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 1281-1Anaestheti
40、c and respiratory equipment Conical connectors Part 1: Cones and sockets prEN 1782Tracheal tubes and connectors EN 20594-1Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements (ISO 594-1 : 1986) EN 30993-1Biological evaluation
41、 of medical devices Part 1: Guidance on selection of tests (ISO 10993-1 : 1992 + Technical Corrigendum 1 : 1992) 3 Definitions For the purposes of this European Standard, the following definitions apply. 3.1 tracheostomy tube Tube designed for insertion into the trachea through a tracheostomy. (EN I
42、SO 4135 : 1996) NOTE. See figures 1a and 1b for an illustration of a typical tracheostomy tube and the associated nomenclature. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1282-1 : 1996 BSI 1997 a) View 1 b) View 2 1. 2. 3. 4.
43、5. 6. Inflating tube Neck plate Cuff, if present Patient end Alternative integral pilot balloon/valve assembly 15 mm male conical fitting in accordance with prEN 1281-1 7. 8. 9. 10. 11. 12. Machine end Outer tube Pilot balloon Inflation valve or closure device Tip rounded Bevel, if present Figure 1.
44、 Typical tracheostomy tube Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:27 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 1282-1 : 1996 BSI 1997 1. Centre-line 2. Neck-plate 3. Datum plane NOTE. The angle u is the obtuse angle formed between the long axes of the tube at the mac
45、hine and patient ends. Figure 2. Basic dimensions of tracheostomy tubes 3.2 machine end a) That end of the tracheostomy tube which is intended to project from the neck of a patient; or b) That end of the connector or the adaptor intended to mate with the breathing system of an anaesthetic machine or
46、 ventilator. (EN ISO 4135 : 1996) 3.3 patient end That end of the tracheostomy tube which is intended to be inserted into the trachea. (EN ISO 4135 : 1996) 3.4 centre-line length Distance from the patient side of the neck-plate to the patient end along the centre-line (see figure 2). NOTE. If the ne
47、ck-plate is adjustable, the centre-line length is variable. 3.5 outer tube That part of the tracheostomy tube which is normally in contact with the tissues. (EN ISO 4135 : 1996) 3.6 inner tube Tube which fits closely to the inside contours of the outer tube (i.e. a tracheostomy tube). (EN ISO 4135 :
48、 1996) 3.7 cuff Inflatable balloon fitted near the patient end of the tracheostomy tube to provide an effective seal between the tube and the trachea. (EN ISO 4135 : 1996) 3.8 inflating tube Tube through which a cuff is inflated. (EN ISO 4135 : 1996) 3.9 pilot balloon Balloon fitted to an inflating
49、tube to indicate inflation of a cuff. (EN ISO 4135 : 1996) 3.10 neck-plate; shield That part of a tracheostomy tube which approximates to the contour of a patients neck and is used to secure a tube in position. (EN ISO 4135 : 1996) 3.11 introducer; obturator Specially adapted stylet to facilitate the introduction of the outer tube into the trachea. (EN ISO 4135 : 1996) 3.12 bevel Slanted portion at the patient end of the tracheostomy tube. (EN ISO 4135 : 1996) 3.13 angle of bevel Acute angle between the plane of the bevel and
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