EN 1782-1998 en Tracheal Tubes and Connectors (Incorporates Amendment A1 2009)《气管导管和连接器 包含修改件A1-2009》.pdf

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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1782:1998 Incorpora

2、ting Corrigendum ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Tracheal tubes and connectors September 1998 + A1:2009 National foreword This British Standard is the UK implementation of EN 1782:1998+A1:2009. It supersedes BS EN 1782:1998 which is withdrawn. The

3、 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 Technic

4、al Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport to include all the nec

5、essary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. BS EN 1782:1998+A1:2009 Amendments/corrigenda issued since publication Amd. No. Date Comments 10173 Corr. No. 1 September 1998 Superse

6、ssion text amended 31 December 2009 Implementation of CEN amendment A1:2009 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 August 1998 BSI 2009 ISBN 978 0

7、 580 68433 3 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1782:1998+A1 August 2009 ICS 11.040.10 Supersedes EN 1782:1998 English Version Tracheal tubes and connectors Tubes trachaux et raccords Trachealtuben und Verbindungsstcke This European Standard was approved by CEN on 2 March 1998 and

8、includes Amendment 1 approved by CEN on 23 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 c

9、oncerning 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 it

10、s 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, Li

11、thuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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 200

12、9 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1782:1998+A1:2009: EEN 1782:1998+A1:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Definitions 5 4 General requirements for tracheal tubes

13、and tracheal tube connectors .7 5 Additional requirements for tracheal tubes with a Murphy eye . 13 6 Requirements for tracheal tubes and tracheal tube connectors supplied sterile . 13 7 Marking 13 Annex A (normative) Test method for determining the resting diameter of the cuff 21 Annex B (normative

14、) Test method for tube collapse 22 Annex C (normative) Test method for cuff herniation 25 Annex D (informative) Guidance on materials and design 27 Annex E (informative) Bibliography . 29 Annex ZA (informative) ! ! ! !Relationship between this European Standard and the Essential Requirements of EU D

15、irective 93/42/EEC“ “ “ “ . 30 BS EN 1782:1998+A1:2009EN 1782:1998+A1:2009 (E) 3 Foreword This document (EN 1782:1998+A1:2009) has been prepared by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI. This European Standard is based on: ISO

16、 5361-1, Tracheal tubes Part 1: General requirements ISO 5361-2, Tracheal tubes Part 2: Oro-tracheal and naso-tracheal tubes of Magill type (plain and cuffed) ISO 5361-3, Tracheal tubes Part 3: Murphy type ISO 5361-5, Tracheal tubes Part 5: Requirements and methods of test for cuffs and tubes ISO 72

17、28, Tracheal tube connectors prepared by the International Organisation for Standardisation (ISO). This European Standard differs from ISO 7228 and the ISO 5361 series in that it permits the use of 8,5 mm connectors for the smaller sizes of tracheal tubes. Annexes A, B and C are normative and form p

18、art of this European Standard. Annexes D, E and ZA are for information only. 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

19、 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 document includes Amendment 1, approved by CEN on 2009

20、-07-23. This document supersedes EN 1782:1998. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports e

21、ssential 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 Regulations, the national standards organizations of the following countries are bound to implement this Europe

22、an 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 Kingd

23、om. BS EN 1782:1998+A1:2009EN 1782:1998+A1:2009 (E) 4 Introduction This European Standard specifies the dimensions, basic properties and method of size designation of the most commonly used types of tracheal tubes made of plastic materials and/or rubber. Tubes with walls reinforced with, e.g. metal

24、or nylon, tubes with shoulders, tapering tubes and the many other types of tubes devised for specialized applications are not specifically covered, although most can be classified by their inside diameter as required by this standard. While the inside diameter has been specified for size designation

25、, the outside diameter should also be marked, since this information is of clinical importance. Clinical considerations have also dictated the apparently excessive specified length of tubes because long tubes, sometimes of relatively narrow diameter, can be urgently required and therefore should be

26、readily available. Provision has also been included for pre-cut tracheal tubes. Cuffed tracheal tubes can be characterized by a combination of the tube inside and outside diameters and by the cuff resting diameter. For tubes intended for re-use, information on the cuff resting diameter should be mar

27、ked on the package or insert but not on the tube itself. This is because re-use may alter the elastic properties, and thereby the diameter, of the cuff. The relationship of cuff and tracheal diameters dictates the intra-cuff pressures required to provide a seal. Excessive pressure on the tracheal wa

28、ll can obstruct capillary blood flow. Tracheal tubes are intended to conform, when in position, as closely as possible to human anatomy. WARNING Whatever type of cuff is used, it is the responsibility of the user to ensure that at any particular time it is inflated with no more than the minimum amou

29、nt of air required to provide an effective seal at the desired lung inflation pressure. A range of cuff designs is available to meet particular clinical requirements. The resting diameter of the cuff should be marked on the unit package as this information allows the clinician to match the product t

30、o the application. Herniation in relation to cuffs is a term widely understood in clinical anaesthetic practice. It is used to describe a cuff which protrudes excessively at its patient end so that it partially or completely occludes the orifice at the bevel. Herniation can be due to a variety of ca

31、uses, singly or in combination: these can include over-inflation of the cuff, traction of the tube when the cuff is inflated or deterioration of the material of the cuff. It should be noted that although certain requirements for cuffs would apply to tubes with an inside diameter of 2,0 to 4,5, cuffs

32、 are infrequently used on these smaller sizes of tubes. Tracheal tube connectors should incorporate 8,5 mm or 15 mm male conical connectors in accordance with EN 1281-1, in order to mate with the appropriate female conical connector of the patient connection port of the breathing system of an anaest

33、hetic machine or ventilator. The designated size of each tracheal tube connector should be not less than that of the tracheal tube with which it is designed to fit, thereby avoiding unnecessary restriction of the gas flow and minimising the risk of inadvertent disconnection. BS EN 1782:1998+A1:2009E

34、N 1782:1998+A1:2009 (E) 5 Flammability of tracheal tubes, for example if flammable anaesthetics, electrosurgical units or lasers are used, is a well-recognised hazard 1)that is addressed by appropriate clinical management, outside the scope of this standard. 1 Scope This European Standard specifies

35、requirements for oro-tracheal and naso-tracheal tubes (plain and cuffed) made of plastics materials and/or rubber and requirements for tracheal tube connectors. Specialized tubes are excluded from the scope of this standard. 2 Normative references This European Standard incorporates by dated or unda

36、ted reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the cited publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only

37、 when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 556:1994, Sterilization of medical devices Requirements for medical devices to be labelled sterile EN 868-1, Packaging materials and systems for medical devices whi

38、ch are to be sterilized Part 1: General requirements and test methods EN 980, Graphical symbols for use in the labelling of medical devices EN 1281-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes,

39、 needles and certain other medical equipment Part 1: General requirements (ISO 594-1:1986) EN 30993-1, Biological evaluation 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 followi

40、ng definitions apply: 3.1 angle of bevel acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end EN ISO 4135:1996 3.2 bevel slanted portion at the patient end of the tracheal tube EN ISO 4135:1996 3.3 cuff inflatable balloon permanently attached a

41、round the tracheal tube near the patient end to provide a seal between the tube and the trachea 1) See ISO/TR 11991. BS EN 1782:1998+A1:2009EN 1782:1998+A1:2009 (E) 6 3.4 inflating tube tube through which the cuff is inflated EN ISO 4135:1996 3.5 inflation lumen lumen within the wall of the tracheal

42、 tube for inflating the cuff 3.6 machine end a) that end of a tracheal tube which is intended to project from a patient EN ISO 4135:1996; or b) that portion of a tracheal tube connector intended to mate with the breathing system of an anaesthetic machine or ventilator. 3.7 Murphy eye hole through th

43、e wall of a tracheal tube near the patient end and on the side opposite to the bevel 3.8 naso-tracheal tube tracheal tube for insertion through the nose into the trachea EN ISO 4135:1996 3.9 oro-tracheal tube tracheal tube for insertion through the mouth into the trachea EN ISO 4135:1996 3.10 patien

44、t end a) that end of a tracheal tube which is intended to be inserted into the trachea EN ISO 4135:1996; or b) that end of a tracheal tube connector nearest to the patient, which is inserted into the tracheal tube. 3.11 pilot balloon balloon fitted to an inflating tube to indicate inflation of a cuf

45、f EN ISO 4135:1996 3.12 tracheal tube tube designed for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea EN ISO 4135:1996 3.13 tracheal tube connector tubular component that fits directly into a tracheal tube EN ISO 4135:1996 3.14 tracheal tube of the

46、 “Magill“ type tracheal tube with a radius of curvature (see 4.7) BS EN 1782:1998+A1:2009EN 1782:1998+A1:2009 (E) 7 4 General requirements for tracheal tubes and tracheal tube connectors 4.1 Size designation The size of tracheal tubes and tracheal tube connectors shall be designed by the nominal ins

47、ide diameter expressed in millimetres in accordance with table 1 for tracheal tubes and table 2 for tracheal tube connectors. 4.2 Dimensions 4.2.1 Tracheal tubes 4.2.1.1 The basic dimensions of tracheal tubes shall be in accordance with table 1. 4.2.1.2 The actual inside diameter shall be the marked

48、 inside diameter subject to a tolerance of 0,15 mm for size 6,0 and smaller, or subject to a tolerance of 0,20 mm for size 6,5 and larger. 4.2.1.3 The actual outside diameter (OD) shall be the marked outside diameter (OD) subject to a tolerance of 0,15 mm for size 6,0 and smaller, or subject to a to

49、lerance of 0,20 mm for size 6,5 and larger (see 7.2.1.1 b). BS EN 1782:1998+A1:2009EN 1782:1998+A1:2009 (E) 8 Table 1 Basic dimensions of tracheal tubes Dimensions in millimetres Designated size (nominal inside diameter) Minimum length of tube A (see figures 1 a) and 1 b) Maximum distance C from the patient end of the tube to the machine end of the inflatable length of the cuff 2)Minimum distance of point of separation of the inflating tube from the patie