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1、BRITISH STANDARD BS 3348:1961 Specification for Antral trocars and cannulae BS 3348:1961 This British Standard, having been approved by, the Surgical Instruments and Medical Appliances Industry Standards Committee and endorsed by the Chairman of the Chemical Divisional Council, was published under t
2、he authority of the General Council on 6 April 1961 BSI 02-2000 The following BSI references relate to the work on this standard: Committee reference SGC/5 Draft for comment A(SGC) 8449 ISBN 0 580 34495 9 Co-operating organizations The Surgical Instruments and Medical Appliances Industry Standards C
3、ommittee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional and industrial organizations: Admiralty* Air Ministry* Association of Hospital Matrons* British Dental Association British Medical Association
4、British Paediatric Association British Surgical Trades Association, Inc.* Federation of British Rubber and Allied Manufacturers Institute of British Surgical Technicians* Medical and Dental Defence Union of Scotland* Medical Defence Union Medical Protection Society Ministry of Agriculture, Fisheries
5、 and Food Ministry of Health* Queens Institute of District Nursing Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists* Royal College of Physicians of London* Royal College of Surgeons of Edinburgh* Royal College of Surgeons of England* Royal College
6、of Veterinary Surgeons Royal Faculty of Physicians and Surgeons of Glasgow War Office* The Government departments and professional and industrial organizations marked with an asterisk in the above list, together with the following, were directly represented on the committee entrusted with the prepar
7、ation of this British Standard: British Association of Otolaryngologists National Federation of Hospital Officers Amendments issued since publication Amd. No.DateComments BS 3348:1961 BSI 02-2000i Contents Page Co-operating organizationsInside front cover Forewordii 1Scope1 2Size range1 3Form and di
8、mensions of trocar and cannula1 4Materials1 5Cannula1 6Tubing mount1 7Resistance to dry heat1 8Marking1 Figure 1 Antral trocar and cannula2 Table 1 Size range of trocars and cannulae2 BS 3348:1961 ii BSI 02-2000 Foreword This standard makes reference to the following British Standards: BS 18, Tensil
9、e testing of metals. BS 970, Wrought steels. En series. BS 1224, Electroplated coatings of nickel and chromium. BS ., Luer conical fitting (6 per cent taper)1). This British Standard was prepared under the authority of the Surgical Instruments and Medical Appliances Industry Standards Committee. The
10、 specification was prepared primarily to provide means of obtaining uniformity in size. Other essentials of design have been specified including the small Luer conical fitting to be standard for connecting the tubing mount to the cannula. NOTEWhere metric equivalents are stated the figures in Britis
11、h units are to be regarded as the standard. The metric conversions are approximate. More accurate conversions should be based on the tables in BS 350, “Conversion factors and tables”, or in BS 2856, “Precise conversions of inch and metric sizes on engineering drawings”. A British Standard does not p
12、urport to include all the necessary 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 fron
13、t cover, pages i and ii, pages 1 and 2 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. 1) In course of preparation. BS 3348:1961 BSI 02-20001 1 Scope This British
14、Standard specifies requirements for a range of sizes of sets of antral trocars and cannulae of the Lichtwitz type. 2 Size range The size range of trocars and cannulae shall be as given in Table 1. The size shall be designated by the Charrire gauge size relating to the external diameter of the cannul
15、a. 3 Form and dimensions of trocar and cannula The form and dimensions of the trocar and cannula shall be in accordance with Figure 1. The handle shall be hollow. When the cannula is fitted to the trocar the projection of the point shall be 5/32 1/32 in. The cannula shall fit snugly behind the troca
16、r point. 4 Materials a) Trocar i) Blade. The blade of the trocar shall be made of hard drawn stainless steel complying with the requirements of BS 9702), En 57 or En 58A, and having a tensile strength not less than 55 tons/in2 (86.6 kg/mm2) when tested in accordance with BS 183). ii) Handle. The han
17、dle shall be made of stainless steel, nickel silver or brass. If the handle is made of brass, it shall be chromium plated on nickel plate, Classification Ni6C, in accordance with BS 12244). b) Cannula. The cannula shall be made of stainless steel complying with the requirements of BS 9702), En 58B a
18、nd having a tensile strength not less than 50 tons/in2 (78.7 kg/mm2) when tested in accordance with BS 183). 5 Cannula The cannula shall be fitted with the small Luer conical socket fitting (6 per cent taper) complying with the requirements of BS .5). 6 Tubing mount A tubing mount if provided shall
19、have the small Luer male conical fitting (6 per cent taper) complying with the requirements of BS .5). 7 Resistance to dry heat The trocar and cannula shall be capable of withstanding dry heat sterilization in an air oven at 180 5 C without deterioration. 8 Marking Components shall be permanently ma
20、rked with the size number in accordance with Clause 2. The number of this British Standard, i.e. BS 33486) may be permanently marked on the components, if required by the purchaser. 2) BS 970, “Wrought steels. En series”. 3) BS 18, “Tensile testing of metals”. 4) BS 1224, “Electroplated coatings of
21、nickel and chromium”. 5) BS , “Luer conical fitting (6 per cent taper)” (in course of preparation). 6) NOTE The mark BS 3348 on the product is an indication by the manufacturer that the goods purport to comply with the requirements of this British Standard. The British Standards Institution is the o
22、wner of the registered certification trade mark shown below. The presence of the certification mark on a product is an additional and independent assurance that the product does comply with the requirements of the relevant British Standard. This certification mark may be used by the manufacturer onl
23、y under licence from the BSI, and particulars of the conditions under which licences are granted may be obtained from the Director, British Standards House, 2 Park Street London, W.1. BS 3348:1961 2 BSI 02-2000 Table 1 Size range of trocars and cannulae Size designation Tubing for cannulaTrocar Maxi
24、mum clearance between internal diameter of cannula and diameter of trocar blade External diameter (Charrire gauge equivalent) Internal diameter (nominal) Diameter (nominal) Charrire gauge 6 7 8 9 in 0.079 0.092 0.105 0.118 mm 2.00 2.33 2.67 3.00 in 0.063 0.070 0.078 0.086 mm 1.60 1.78 1.98 2.18 S.W.
25、G. 17 16 15 14 in 0.056 0.064 0.072 0.080 mm 1.42 1.63 1.83 2.03 in 0.007 0.006 0.006 0.006 mm 0.18 0.15 0.15 0.15 Dimensions are in inches 1 in = 25.4 mm exactly Figure 1 Antral trocar and cannula blank BS 3348:1961 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is t
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