BS 6155-1990 Specification for tracheal tubes for large animals in veterinary anaesthesia《大牲畜兽医麻醉用气管插管规范》.pdf

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1、BRITISH STANDARD BS 6155:1990 Incorporating Amendment No. 1 Specification for Tracheal tubes for large animals in veterinary anaesthesia ICS 11.220 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS 6155:1990 This British Standard, having been prepared under the direction of th

2、e Health Care Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 31 May 1990 BSI 08-2001 First published November 1981 First revision May 1990 The following BSI references relate to the work on this standard: Committee reference HCC/45 Draft fo

3、r comment 89/50618 DC ISBN 0 580 18425 0 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 Anaes

4、thetists of Great Britain and Ireland Association of British Health Care Industries Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association British Association of Otolaryngologists British Paediatric Association Bri

5、tish Rubber Manufacturers Association British Surgical Trades Association Department of Health Medical Sterile Products Association Amendments issued since publication Amd. No. Date Comments 13225 August 2001 Indicated by a sidelineBS 6155:1990 BSI 08-2001 i Contents Page Committees responsible Insi

6、de front cover Foreword ii 1S c o p e 1 2 Definitions 1 3M a t e r i a l s 1 4 Size designation 1 5D i m e n s i o n s 2 6B e v e l 2 7C u f f 2 8 Inflating tube 2 9 Information to be provided by the manufacturer or supplier 4 10 Marking 4 Appendix A Recommendations for materials and design 5 Append

7、ix B deleted 5 Figure 1 Tracheal tubes for large animals in veterinary anaesthesia 3 Figure 2 deleted 5 Table 1 Dimensions of tracheal tubes for veterinary use 2 Publications referred to Inside back coverBS 6155:1990 ii BSI 08-2001 Foreword This revision of BS 6155 has been prepared under the direct

8、ion of the Health Care Standards Policy Committee. It supersedes BS 6155:1981, which is withdrawn. The principal differences from the 1981 edition of this British Standard are as follows. a) The dimensions of the tubes have been amended to bring them in line with those of tubes currently used in pra

9、ctice. b) Requirements for freedom from biological hazard have been specified by reference to the methods given in BS 5736-4 and BS EN ISO 10993-5. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct

10、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 6, an inside back cover and a back cover. The BSI copyright notice displayed in this do

11、cument indicates when the document was last issued. Sidelining in this document indicates the most recent changes by amendment.BS 6155:1990 BSI 08-2001 1 1 Scope This British Standard specifies requirements for cuffed oral tracheal tubes intended for use with large animals in veterinary anaesthesia.

12、 NOTE 1 Recommendations for materials and design 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 Standard, the following definitions apply. 2.1 tracheal (endotracheal) tube

13、 tube intended for insertion through the larynx into the trachea to convey gases and vapours to and from the trachea 2.2 patient end that end of the tracheal tube which is intended to be inserted into the trachea 2.3 machine end that end of the tracheal tube which is intended to project from the pat

14、ient 2.4 bevel slanted portion at the patient end of the tracheal tube 2.5 angle of bevel acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end 2.6 cuff inflatable sleeve fitted near the patient end of the tracheal tube to provide an effective f

15、it between the tube and the trachea 2.7 bonded cuff cuff permanently attached to the tracheal tube 2.8 inflating tube tube through which the cuff is inflated 2.9 pilot balloon balloon fitted to the inflating tube to indicate inflation of the cuff 2.10 large animal any animal that requires the use of

16、 tubes larger than those specified in BS EN 1782, and including the larger breeds of dog, such as greyhound, Alsatian and Great Dane 3 Materials The materials of the tracheal tube, including the cuff, shall be assessed as being free from biological hazard when tested in accordance with BS 5736-4 and

17、 BS EN ISO 10993-5. 4 Size designation The sizes of tracheal tubes shall be designated by their nominal inside diameter expressed in millimetres.BS 6155:1990 2 BSI 08-2001 5 Dimensions 5.1 The dimensions of tracheal tubes shall be as given in Table 1. Table 1 Dimensions of tracheal tubes for veterin

18、ary use 5.2 The outside diameter of tracheal tubes shall be within 5 % of the nominal value marked either on the tube see 10.1.1c) or on the package see 10.2e). 6 Bevel Tracheal tubes shall have a bevel with the opening to the left when the tube is viewed from the machine end towards the concave asp

19、ect, bevel end uppermost. The angle of the bevel shall be 45 7 . 7 Cuff The inflatable length of the cuff and its distance from the patient end of the tracheal tube shall be as given in Table 1. 8 Inflating tube 8.1 General 8.1.1 The inflating tube shall have an outside diameter not exceeding 4.5 mm

20、 and shall be situated on the concave aspect of the tracheal tube. The inflating tube shall not encroach on the lumen of the tracheal tube. 8.1.2 The dimensions of the inflating tube shall be such that dimension S 1(see Figure 1) shall be 75 + 15, 10 % of the length of the tracheal tube and the sum

21、of S 1and S 2shall be not less than the length of the tube. 8.1.3 If the inflating tube is attached externally to the tracheal tube between the cuff and the point of separation (see Figure 1), the attachment shall be such that the inflating tube can be partly stripped from the tracheal tube, if requ

22、ired. 8.1.4 The inflating tube shall be attached to the tracheal tube such that the angle between the inflating tube and the machine end of the tracheal tube at the point of separation (see Figure 1) shall not exceed 45 . NOTE The inflating tube should join the tracheal tube in such a manner to ensu

23、re that any projection will not interfere with clinical use of the tube. Designated size (nominal inside diameter) Inside diameter Minimum length of tube L a Inflatable length of cuff C a Distance of cuff from the patient end B a Radius of curvature mm mm mm mm mm 40 40 1 1 200 200 20 60 21 550 100

24、35 35 1 1 045 200 20 60 21 500 100 30 30 0.8 1 045 190 19 60 21 450 100 25 25 0.8 1 045 180 18 60 21 400 100 20 20 0.6 1 045 160 16 60 21 400 100 18 18 0.6 1 045 160 16 60 21 400 100 16 Standard 16 0.6 310 60 6 30 8 250 60 Long b 16 0.6 550 60 6 30 8 250 60 14 Standard 14 0.4 310 60 6 25 7 250 60 Lo

25、ng b 14 0.4 550 60 6 25 7 250 60 12 Standard 12 0.4 310 50 5 25 7 250 60 Long b 12 0.4 550 50 5 25 7 250 60 a See Figure 1. b These tubes are required for pigs, deer, antelope and other animals.BS 6155:1990 BSI 08-2001 3 8.2 Pilot balloon The inflating tube shall be provided with a pilot balloon (se

26、e Figure 1). The pilot balloon shall be so constructed as to give an indication of the inflation of the cuff and shall not prevent evacuation of the cuff. 8.3 Free end of the inflating tube The free end of the inflating tube shall either be open or be fitted with a closure device or valve. If the en

27、d is open, either it shall accept a male conical fitting with a 6 % (Luer) taper complying with BS EN 20594-1 or the inflating tube shall be fitted with an insert having a female conical fitting with a 6 % (Luer) taper complying with BS EN 20594-1. Except when an inflation valve or closure device is

28、 provided, the length of the free end of the tube (dimension S 3in Figure 1) shall be not less than 40 mm. Figure 1 Tracheal tubes for large animals in veterinary anaesthesiaBS 6155:1990 4 BSI 08-2001 9 Information to be provided by the manufacturer or supplier For tracheal tubes intended for re-use

29、, the manufacturer or supplier shall provide recommended methods of cleaning and sterilization or disinfection. NOTE The recommended method(s) should not produce changes in the tube material which will give rise to a biological hazard (see clause 3). 10 Marking 10.1 Marking of tracheal tubes 10.1.1

30、Tracheal tubes intended for re-use shall be permanently and legibly marked with at least the following: a) the name and/or trademark of the manufacturer or supplier; b) the designated size of the tube (see clause 4); c) the nominal outside diameter of the tube expressed in millimetres; d) a means of

31、 identifying the date of manufacture; e) the number and date of this British Standard, i.e. BS 6155:1990 1) . NOTE The marking should resist removal by anaesthetic agents and by the methods of cleaning and disinfection or sterilization recommended by the manufacturer. 10.1.2 The marking shall be sit

32、uated on the bevelled side of the tube as shown in Figure 1 and shall read from the patient end to the machine end of the tube. NOTE This will permit the machine end of the tube to be shortened if required without interfering with the marking. 10.2 Marking of packages Packages containing tracheal tu

33、bes intended for single use shall be clearly marked 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 name and/or trademark of the manufacturer or supplier; d) the designated size of the t

34、ube (see clause 4); e) the nominal outside diameter of the tube expressed in millimetres; f) a means of identifying the date of manufacture; g) the number and date of this British Standard, i.e. BS 6155:2001 1) . 1) Marking BS 6155:2001 on or in relation to a product represents a manufacturers decla

35、ration of conformity, i.e. a claim by or on behalf of 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 to be confused with third party certification of

36、conformity, which may also be desirable.BS 6155:1990 BSI 08-2001 5 Appendix A Recommendations for materials and design A.1 Tracheal tubes should be resistant to deterioration resulting from use with anaesthetic vapours and gases. A.2 The tube material should have sufficient rigidity to allow the con

37、struction of tubes with the thinnest possible wall which at the same time maintain a degree of resistance to kinking. When not in use, the specified radius of curvature of the tube should be approximately maintained. When in place it should be flexible and soft enough to conform to the anatomy of th

38、e animal without exerting undue pressure on the body tissues. A.3 Tracheal tubes should be readily detectable by X-ray either by the nature of the material of which they are made or by provision of a marker at the patient end. A.4 The end of the tube at the bevel should be rounded and the orifice sh

39、ould be free from sharp edges. A.5 A permanently bonded cuff should be capable of approximately symmetrical expansion when the cuff is inflated with air. Appendix B deleted6 blankBS 6155:1990 BSI 08-2001 Publications referred to BS 3930-1, Specification for general requirements. BS 5736, Evaluation

40、of medical devices for biological hazards. BS 5736-4, Method of test for intracutaneous reactivity of extracts from medical devices. BS EN 980, Graphical symbols for use in the labelling of medical devices. BS EN 1782, Tracheal tubes and connectors. BS EN 20594-1, Conical fittings with a 6 % (Luer)

41、taper for syringes, needles and certain other medical equipment Part 1: General requirements. BS EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.BS 6155:1990 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the indepen

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