《BS-6155-1990.pdf》由会员分享,可在线阅读,更多相关《BS-6155-1990.pdf(12页珍藏版)》请在三一文库上搜索。
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 LAW Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, U
2、ncontrolled Copy, (c) BSI BS 6155:1990 This British Standard, having been prepared 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 31 May 1990 BSI 08-2001 First published November 1981 First revision Ma
3、y 1990 The following BSI references relate to the work on this standard: Committee reference HCC/45 Draft for 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 (
4、HCC/-) to Technical Committee HCC/45, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health Care Industries Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equ
5、ipment Manufacturers Association British Association of Otolaryngologists British Paediatric Association British Rubber Manufacturers Association British Surgical Trades Association Department of Health Medical Sterile Products Association Amendments issued since publication Amd. No.DateComments 132
6、25August 2001 Indicated by a sideline Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 BSI 08-2001 i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Definitions1 3Materials1 4Size designation1 5Dimensio
7、ns2 6Bevel2 7Cuff2 8Inflating tube2 9Information to be provided by the manufacturer or supplier4 10Marking4 Appendix A Recommendations for materials and design5 Appendix B deleted5 Figure 1 Tracheal tubes for large animals in veterinary anaesthesia3 Figure 2 deleted5 Table 1 Dimensions of tracheal t
8、ubes for veterinary use2 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 ii BSI 08-2001 Foreword This revision of BS 6155 has been prepared under the direction of the Health Care Standar
9、ds 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 practice. b) Requirements for fre
10、edom 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 application. Compliance with a
11、 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 document indicates when the docu
12、ment was last issued. Sidelining in this document indicates the most recent changes by amendment. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 BSI 08-2001 1 1 Scope This British Standard specifies requirements for cuffed oral
13、 tracheal tubes intended for use with large animals in veterinary anaesthesia. NOTE 1Recommendations for materials and design are given in Appendix A. NOTE 2The titles of the publications referred to in this standard are listed on the inside back cover. 2 Definitions For the purposes of this British
14、 Standard, the following definitions apply. 2.1 tracheal (endotracheal) tube 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
15、 end that end of the tracheal tube which is intended to project from the patient 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 sleev
16、e fitted near the patient end of the tracheal tube to provide an effective fit 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
17、 inflation of the cuff 2.10 large animal any animal that requires the use of 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 be
18、ing free from biological hazard when tested in accordance with BS 5736-4 and BS EN ISO 10993-5. 4 Size designation The sizes of tracheal tubes shall be designated by their nominal inside diameter expressed in millimetres. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006
19、, Uncontrolled Copy, (c) BSI 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 veterinary use 5.2 The outside diameter of tracheal tubes shall be within 5 % of the nominal value marked either on the tub
20、e 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 aspect, bevel end uppermost. The angle of the bevel shall be 45?7?. 7 Cuff The inflatable length of the cuff and its di
21、stance 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 and shall be situated on the concave aspect of the tracheal tube. The inflating tube shall not encroach on the lume
22、n of the tracheal tube. 8.1.2 The dimensions of the inflating tube shall be such that dimension S1 (see Figure 1) shall be 75 + 15, 10 % of the length of the tracheal tube and the sum of S1 and S2 shall be not less than the length of the tube. 8.1.3 If the inflating tube is attached externally to th
23、e 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 required. 8.1.4 The inflating tube shall be attached to the tracheal tube such that the angle between the inflating tube
24、 and the machine end of the tracheal tube at the point of separation (see Figure 1) shall not exceed 45?. NOTEThe inflating tube should join the tracheal tube in such a manner to ensure that any projection will not interfere with clinical use of the tube. Designated size (nominal inside diameter) In
25、side diameter Minimum length of tube La Inflatable length of cuff Ca Distance of cuff from the patient end Ba Radius of curvature mmmmmmmmmm 4040 ? 11 200200 ? 2060 ? 21550 ? 100 3535 ? 11 045200 ? 2060 ? 21500 ? 100 3030 ? 0.81 045190 ? 1960 ? 21450 ? 100 2525 ? 0.81 045180 ? 1860 ? 21400 ? 100 202
26、0 ? 0.61 045160 ? 1660 ? 21400 ? 100 1818 ? 0.61 045160 ? 1660 ? 21400 ? 100 16 Standard16 ? 0.6 31060 ? 630 ? 8250 ? 60 Longb16 ? 0.6 55060 ? 630 ? 8250 ? 60 14 Standard14 ? 0.4 31060 ? 625 ? 7250 ? 60 Longb14 ? 0.4 55060 ? 625 ? 7250 ? 60 12 Standard12 ? 0.4 31050 ? 525 ? 7250 ? 60 Longb12 ? 0.4 5
27、5050 ? 525 ? 7250 ? 60 a See Figure 1. b These tubes are required for pigs, deer, antelope and other animals. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 BSI 08-2001 3 8.2 Pilot balloon The inflating tube shall be provided w
28、ith a pilot balloon (see 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 dev
29、ice or valve. If the end 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 val
30、ve or closure device is provided, the length of the free end of the tube (dimension S3 in Figure 1) shall be not less than 40 mm. Figure 1 Tracheal tubes for large animals in veterinary anaesthesia Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c)
31、 BSI BS 6155:1990 4 BSI 08-2001 9 Information to be provided by the manufacturer or supplier For tracheal tubes intended for re-use, the manufacturer or supplier shall provide recommended methods of cleaning and sterilization or disinfection. NOTEThe recommended method(s) should not produce changes
32、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 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) t
33、he designated size of the tube (see clause 4); c) the nominal outside diameter of the tube expressed in millimetres; d) a means of identifying the date of manufacture; e) the number and date of this British Standard, i.e. BS 6155:19901). NOTEThe marking should resist removal by anaesthetic agents an
34、d by the methods of cleaning and disinfection or sterilization recommended by the manufacturer. 10.1.2 The marking shall be situated 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. NOTEThis will permit the machine end of the t
35、ube to be shortened if required without interfering with the marking. 10.2 Marking of packages Packages containing tracheal tubes intended for single use shall be clearly marked with the following: a) a description of the contents; b) the words “SINGLE USE”; NOTEThe symbol described in BS EN 980 may
36、 also be marked on the package. c) the name and/or trademark of the manufacturer or supplier; d) the designated size of the tube (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 Bri
37、tish Standard, i.e. BS 6155:20011). 1)Marking BS 6155:2001 on or in relation to a product represents a manufacturers declaration 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
38、responsibility of the person making the claim. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 BSI 08-2001 5 App
39、endix 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 construction of tubes with the thinnest possible wall which at the same t
40、ime 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 the animal without exerting undue pressure on the body tissues. A.3 Trac
41、heal 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 should be free from sharp edges. A.5 A permanently bonded cuff should be
42、 capable of approximately symmetrical expansion when the cuff is inflated with air. Appendix B deleted Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 6 blank Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Un
43、controlled Copy, (c) BSI BS 6155:1990 BSI 08-2001 Publications referred to BS 3930-1, Specification for general requirements. BS 5736, Evaluation of medical devices for biological hazards. BS 5736-4, Method of test for intracutaneous reactivity of extracts from medical devices. BS EN 980, Graphical
44、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) taper for syringes, needles and certain other medical equipment Part 1: General requirements. BS EN ISO 10993-5, Biological evaluation of medical devices
45、Part 5: Tests for in vitro cytotoxicity. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:28:01 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6155:1990 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing B
46、ritish Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It
47、is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside fron
48、t cover. Tel: 020 8996 9000. Fax: 020 8996 7400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications should be addres
49、sed to Customer Services. Tel: 020 8996 9001. Fax: 020 8996 7001. Standards are also available from the BSI website at http:/www.bsi-. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British Standards, unless otherwise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information
链接地址:https://www.31doc.com/p-3773798.html