BS 7143-1989 Specification for catheter mounts (flexible adaptors) for use with medical breathing systems《医用呼吸系统导管架(挠性连接器)规范》.pdf

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1、BRITISH STANDARD BS 7143:1989 Incorporating Amendments Nos. 1 and 2 Specification for Catheter mounts (flexible adaptors) for use with medical breathing systems ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS 7143:1989 This British Standard, having been prepare

2、d under the direction of the Health Care Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 29 September 1989 BSI 12 November 2001 The following BSI references relate to the work on this standard: Committee reference HCC/45 Draft for comment 88

3、/50374 DC ISBN 0 580 17426 3 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/45, upon which the following bodies were represented: Association of Anaesthetists of

4、Great Britain and Ireland Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association British Association of Otolaryngologists British Health-Care Trade and Industry Council British Paediatric Association British Rubber

5、 Manufacturers Association British Surgical Trades Association Incorporated Department of Health Medical Sterile Products Association Amendments issued since publication Amd. No. Date of issue Comments 7063 June 1992 13226 12 November 2001 Indicated by a sidelineBS 7143:1989 BSI 12 November 2001 i C

6、ontents Page Committees responsible Inside front cover Foreword ii 1S c o p e 1 2 Definitions 1 3D e s i g n 1 4 Performance 2 5 Electrical conductivity 2 6C o l o u r 2 7M a r k i n g 2 Appendix A Recommendations for materials 4 Appendix B Method of test for disengagement 4 Appendix C Method of tes

7、t for security of attachment of machine and patient ends 4 Appendix D Method of test for resistance to collapse of catheter mounts when flexed 4 Appendix E Method of test for resistance to collapse of catheter mounts when rotated 5 Appendix F deleted Figure 1 Examples of catheter mounts 3 Figure 2 T

8、est rig for measuring resistance to collapse of catheter mounts when flexed 6 Figure 3 Test rig for measuring resistance to collapse of catheter mounts when rotated 7 Figure 4 deleted Publications referred to Inside back coverBS 7143:1989 ii BSI 12 November 2001 Foreword This British Standard has be

9、en prepared under the direction of the Health Care Standards Policy Committee. BS EN 1782, BS EN 1282-1 and BS EN 1282-2 specify requirements for tracheal and tracheostomy tube connectors and are predominantly concerned with connectors having a 15 mm male conical connector, complying with BS EN 1281

10、-1, which can mate directly with the patient connection port of the breathing system of an anaesthetic machine or lung ventilator. This direct method of connection, although widely applicable, may be less satisfactory in certain circumstances, for example, for operations on the face, or when the pat

11、ient is in the prone position, or during prolonged ventilation in an intensive care unit. In these instances it is often preferable to interpose a short length of flexible tubing (known as a catheter mount) between the patient connection port and the tracheal or tracheostomy tube connector. This ind

12、irect method of connection has the additional merit that the flexible tubing helps to absorb the strains caused by inadvertent movement of the patients head or the breathing system, and thus reduces the likelihood of accidental disconnections.Accordingly, this British Standard specifies dimensional

13、requirements for the patient end of catheter mounts to accommodate components of size range 12 mm to 14 mm as well as specifying catheter mounts with a 15 mm female conical connector at the patient end (see 3.2). Provision is also made in this British Standard for detailed variations in design of th

14、e catheter mounts and, in accordance with international agreement, for three types of connector at the machine end. However, experience in the UK has led to a preference for using the 22 mm female conical connector at the machine end. A British Standard does not purport to include all the necessary

15、provisions of a contract. Users of British Standards are responsible for their correct application. 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, pages 1 to

16、8, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Sidelining in this document indicates the most recent changes by amendment.BS 7143:1989 BSI 12 November 2001 1 1 Scope This British Standard specifies requiremen

17、ts for catheter mounts (flexible adaptors) intended to connect anaesthetic or ventilator breathing systems to tracheal or tracheostomy tube connectors. It does not specify requirements for tracheal and tracheostomy tube connectors, these being given in BS EN 1782, BS EN 1282-1 and BS EN 1282-2. Typi

18、cal examples of catheter mounts covered by this British Standard are shown in Figure 1. NOTE 1 Recommendations for materials are given in Appendix A. NOTE 2 The titles of the publications referred to in this standard are listed on the inside back cover. 2 Definitions For the purposes of this British

19、 Standard, the following definitions apply. 2.1 catheter mount a flexible adaptor for joining or connecting the patient connection port of a breathing system to a tracheal or tracheostomy tube connector 2.2 tracheal tube connector a tubular component that fits directly into the tracheal tube 2.3 mac

20、hine end of a catheter mount that end of the catheter mount intended to be connected to the patient connection port of the breathing system 2.4 patient end of a catheter mount that end of the catheter mount intended to be connected to a tracheal tube connector 2.5 patient connection port that openin

21、g at the patient end of a breathing system intended for connection, for example, to a tracheal or tracheostomy tube connector or adaptor, a face mask or a face mask angle-piece 3 Design 3.1 Machine end The machine end of the catheter mount shall have an inside diameter of not less than 11 mm and its

22、 connector shall be one of the following. a) A 22 mm female conical connector complying with BS EN 1281-1. b) A non-conical elastomeric connector of 22 mm axial length and 18 0.5 mm inside diameter, when measured in the unstretched condition, which, when tested as described in Appendix B, shall not

23、become disengaged from the 22 mm male conical connector. c) A 15 mm male conical connector complying with BS 1281-1. 3.2 Patient end The patient end of the catheter mount shall either be a non-conical elastomeric connector having a minimum length of 13 mm and an inside diameter of 9.5 0.5 mm, when m

24、easured in the unstretched condition, or be fitted with a 15 mm female conical connector complying with BS 1281-1. 3.3 Intermediate section The length of the intermediate section shall be not greater than 200 mm. The inside diameter shall be between 11 mm and 19 mm.BS 7143:1989 2 BSI 12 November 200

25、1 4 Performance 4.1 Detachment of ends When tested as described in Appendix C, the connectors at the machine end and at the patient end, if the latter is a 15 mm female conical connector complying with BS EN 1281-1, shall not become detached from the intermediate section. 4.2 Resistance to collapse

26、4.2.1 When tested as described in Appendix D, the increase in pressure shall not exceed 0.4 kPa. 4.2.2 When tested as described in Appendix E, the increase in pressure shall not exceed 0.2 kPa when the catheter mount is rotated through 90 and 0.4 kPa when the catheter mount is rotated through 180 .

27、5 Electrical conductivity The electrical conductivity of catheter mounts that are made of conductive (antistatic) material and are intended for use with flammable anaesthetics shall comply with BS 2050. 6 Colour Catheter mounts made of conductive (antistatic) material shall be black and those made o

28、f non-conductive material shall not be black. NOTE Catheter mounts made of conductive (antistatic) material should bear a conspicuous yellow-coloured marking. 7 Marking 7.1 Marking of catheter mounts Catheter mounts intended for re-use shall be permanently and legibly marked with the following: a) t

29、he name and/or trade mark of the manufacturer; b) an identification reference to the batch or date of manufacture; c) the number and date of this British Standard, i.e. BS 7143:1989 1) . 7.2 Marking of packages 7.2.1 Packages containing catheter mounts intended for single use shall be clearly marked

30、 with the following. a) A description of the contents. b) The words “SINGLE USE”. NOTE The symbol described in BS EN 980 may also be marked on the package. c) The words “STERILE” or “NON-STERILE, as appropriate. d) The name and/or trade mark of the manufacturer or supplier. e) An identification refe

31、rence to the batch or date of manufacture. f) The number and date of this British Standard, i.e. BS 7143:1989 1) . 7.2.2 Packages containing catheter mounts intended for re-use shall be clearly marked with the following: a) a description of the contents; b) the name and/or trade mark of the manufact

32、urer or supplier; c) recommended methods of cleaning and disinfection or sterilization; d) the number and date of this British Standard, i.e. BS 7143:1989 1) . 1) Marking BS 7143:1989 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of

33、 the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is therefore solely the responsibility of the person making the claim. Such a declaration is not be confucsed with third party certification of conformity, which may also be desirable.BS 7143:1989 BS

34、I 12 November 2001 3 7.2.3 Packages containing catheter mounts made of non-conductive material shall be clearly marked with the words “NON-CONDUCTIVE”. Dimensions in millimetres Figure 1 Examples of catheter mounts 18 22 min. Elastomeric Machine ends Patient ends 22 female conical connector complyin

35、g with BS EN 1281-1 15 female conical connector complying with BS EN 1281-1 15 male conical connector complying with BS EN 1281-1 Intermendiate section 200 max. 13 min. Elastomeric 0,5 i.d. + - 9,50,5 i.d. + -BS 7143:1989 4 BSI 12 November 2001 Appendix A Recommendations for materials A.1 Catheter m

36、ounts should be made of materials that are resistant to anaesthetic agents. A.2 Unless marked as being for single use, catheter mounts should be resistant to those methods of cleaning and disinfection or sterilization recommended by the manufacturer or supplier. Catheter mounts not intended for sing

37、le use should withstand normal methods of steam sterilization. NOTE Attention is drawn to the absorption of volatile anaesthetic agents and other substances by catheter mounts. These agents and substances may be subsequently liberated and may pose a hazard. Also, for catheter mounts of a laminated c

38、onstruction, there is a risk of internal delamination and bubble formation when they are exposed to volatile anaesthetic agents. Appendix B Method of test for disengagement B.1 Wet the machine end of the catheter mount with distilled water and engage it by hand with a 22 mm male conical connector ma

39、de of metal, with dimensions as specified in BS EN 1281-1 and having a surface roughness of 0.8 m (roughness number N6) when determined as specified in BS 1134-1. Ensure that engagement is beyond the major diameter of the conical connector. B.2 Apply a tensile load of 40 N for 1 min along the linear

40、 axis of the catheter mount at least 50 mm from the machine end and note whether the catheter mount becomes disengaged from the conical connector. Appendix C Method of test for security of attachment of machine and patient ends C.1 Secure the end of the catheter mount under test such that the connec

41、tor is not distorted. C.2 Apply a tensile load of 80 N for 1 min along the linear axis of the catheter mount at least 50 mm from the end under test and note whether the connector becomes detached from the intermediate section. C.3 Repeat for the other end of the catheter mount. Appendix D Method of

42、test for resistance to collapse of catheter mounts when flexed D.1 Principle The catheter mount is formed into a U shape and fitted between two parallel plates which are progressively closed together causing the tube to bend through 180 around a tightening radius of curvature. The increase in resist

43、ance to an air flow of 60 L/min is measured. D.2 Apparatus D.2.1 Test rig, as shown in Figure 2 capable of controlled closure of the parallel faces of the fixed and moving plates. The inside diameter of the T-piece shall be not less than the minimum inside diameter of the intermediate section of the

44、 catheter mount under test. D.2.2 Metered air supply, capable of delivering a continuous flow of 60 L/min. D.3 Procedure D.3.1 Lay the catheter mount in a straight line. If the catheter mount is intended to be of adjustable length, fully extend it. Connect the catheter mount to the air supply (D.2.2

45、) and adjust the air flow to 60 L/min. Record the pressure indicated on the manometer. D.3.2 Bend the catheter mount into a U shape and fit it into the test rig (D.2.1). Progressively move the moving plate towards the fixed plate until the corrugations or outside surfaces of the catheter mount come

46、into contact with each other. D.3.3 Adjust the flow, if necessary, to 60 L/min and record the pressure indicated on the manometer. D.3.4 Calculate the increase in pressure by subtracting the pressure recorded in D.3.1 from that recorded in D.3.3.BS 7143:1989 BSI 12 November 2001 5 Appendix E Method

47、of test for resistance to collapse of catheter mounts when rotated E.1 Principle One end of the catheter mount is rotated through 90 with the other end fixed and the increase in resistance to an air flow of 60 L/min is measured. This is repeated for an angle of 180 . E.2 Apparatus E.2.1 Test rig, as

48、 shown in Figure 3. The inside diameter of the T-piece shall be not less than the minimum inside diameter of the intermediate section of the catheter mount under test. E.2.2 Metered air supply, capable of delivering a continuous flow of 60 L/min. E.3 Procedure E.3.1 Clamp the catheter mount in the t

49、est rig (E.2.1) ensuring that it is not under longitudinal tension. If the catheter mount is intended to be of adjustable length, fully extend it before it is clamped in the test rig. E.3.2 Connect the catheter mount to the air supply (E.2.2) and adjust the air flow to 60 L/min. Record the pressure indicated on the manometer.BS 7143:1989 6 BSI 12 November Figure 2 Test rig for measuring resistance to collapse of catheter mounts when flexedBS 7143:1989 BSI 12 November 2001 7 E.3.3 Rotate the end of the catheter mount in the sliding clamp through a