BS 3271-1970 Specification for surgical elastic band trusses《外科用弹性吊带规范》.pdf

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1、BRITISH STANDARD BS 3271:1970 Incorporating Amendment No. 1 Specification for Surgical elastic band trussesBS3271:1970 This British Standard, having been approved by the Surgical Instruments and Medical Appliances Industry Standards Committee, was published under the authority of the Executive Board

2、 on 31 March 1970 BSI 02-2000 First published August 1960 First revision March 1970 The following BSI references relate to the work on this standard: Committee reference HCC/9 (formerly SGC/9/2) Draft for comment 68/8145 ISBN 0 580 05596 5 Co-operating organizations The Surgical Instruments and Medi

3、cal Appliances Industry Standards Committee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional and industrial organizations: Association of Hospital Matrons British Dental Association British Medical Ass

4、ociation* British Surgical Trades Association (Inc.)* British Rubber Manufacturers Association Ltd. Institute of British Surgical Technicians Medical Defence Union Medical and Dental Defence Union of Scotland Medical Protection Society Ministry of Agriculture, Fisheries and Food Ministry of Defence

5、Air Force Department Ministry of Defence Army Department Ministry of Defence Navy Department Department of Health and Social Security* Queens Institute of District Nursing Royal College of Midwives Royal College of Nursing Royal College of Obstetricians and Gynaecologists Royal College of Physicians

6、 and Surgeons of Glasgow Royal College of Physicians of London Royal College of Surgeons of Edinburgh Royal College of Surgeons of England* Royal College of Veterinary Surgeons Royal Institute of Public Health and Hygiene The Government departments and professional and industrial organizations marke

7、d with an asterisk in the above list, together with the following, were directly represented on the Committee entrusted with the preparation of this British Standard: Aluminium Development Association British Investment Casters Technical Association British Orthopaedic Association British Plastics F

8、ederation British Steel Industry Central Council for the Care of Cripples Institution of Production Engineers National Federation of Hospital Officers National Pharmaceutical Union Surgical Appliance Manufacturers Association Individual firms Amendments issued since publication Amd. No. Date of issu

9、e Comments 5867 May 1989 Indicated by a sideline in the marginBS3271:1970 BSI 02-2000 i Contents Page Co-operating organizations Inside front cover Foreword ii 1 Scope 1 2 Terminology 1 3 General requirements for all metal components 1 4 Plate 1 5 Rivets 2 6 Eyelets 2 7 Screws 2 8 Buckles and other

10、fastening equipment 2 9 Elastic band 2 10 Covering of the angled portion of the joint of the elastic band 2 11 Buckle shield 2 12 Outer face covering of pad 2 13 Felling piece 2 14 Plate cover 2 15 Core of the pad 2 16 Padding 3 17 Inner face covering 3 18 Tailstrap 3 19 Understrap buckle piece 3 20

11、 Sewing thread 3 21 Assembly of buckle shield 4 22 Assembly of pad 4 23 Assembly of elastic band trusses with fixed pads 4 24 Assembly of elastic band trusses with detachable pads 5 25 Marking 5 Appendix A Woven webbing materials 6 Appendix B Requirements for leather used in the manufacture of elast

12、ic band trusses 9 Table 1 Woven elastic webbing nominal width 44 mm (1 3 / 4in) 7 Table 2 Woven elastic webbing nominal width 19 mm ( 3 / 4in) 8 Table 3 Non-elastic webbing nominal width 19 mm ( 3 / 4in) 9BS3271:1970 ii BSI 02-2000 Foreword This standard makes reference to the following British Stan

13、dards and BSI publication: BS 57, B.A. screws, bolts and nuts. BS 93, British Association (B.A.) screw threads with tolerances for sizes 0 B.A. to 16 B.A. BS 903, Methods of testing vulcanized rubber. BS 947, Specification for a universal system for designating linear density of textiles (Tex system

14、). BS 1309, Methods of sampling and analysis of vegetable-tanned and chrome-tanned leathers. BS 1449, Steel plate, sheet and strip Part 1: Specification for carbon and carbon-manganese plate, sheet and strip. BS 1470, Wrought aluminium and aluminium alloys for general engineering purposes. Sheet and

15、 strip. BS 1554, Specification for stainless and heat-resisting steel round wire. BS 1897, Woven elastic webbings. BS 2010, Method for determination of the linear density of yarns from packages. BS 2576, Methods for the determination of breaking load and extension of strips of woven textile fabric.

16、BS 2874, Specification for copper and copper alloy rods and sections (other than forging stock). BS 3102, Brass eyelets and washers for general purposes. BS 3144, Methods of sampling and physical testing of leather. BS 4183, Machine screws and machine screw nuts metric series. The first edition of B

17、S 3271 published in 1960 was prepared following a request made by the Ministry of Health and was authorized by the Surgical Instruments and Medical Appliances Industry Standards Committee of the British Standards Institution. This revised edition of BS 3271 brings up to date present requirements for

18、 surgical elastic band trusses with respect to materials and methods of fabrication, together with such dimensions of components as are independent of individual clinical requirements. Provision is made for the use of adhesives in the construction of the pad. Changes have been made to requirements f

19、or elastic webbing and certain details of fabrication. In accordance with prescribed national policy the opportunity has been taken for requirements to be specified in metric units although equivalents in the customary imperial units have been included for convenience during the pending change to ge

20、neral use of the metric system in the United Kingdom. Likewise, provision has been made for use of screws having ISO metric threads which it is intended will ultimately take the place of the BA system of screw threads. Surgical spring trusses are dealt with in BS 2930. NOTEMetric units are to be reg

21、arded as the standard. Where equivalents are given in other units they are approximate. More accurate conversions should be based on the tables in BS 350 “Conversion factors and tables”, or in BS 2856 “Precise conversion of inch and metric sizes on engineering drawings”. Imperial units have been ret

22、ained, however, for certain textile requirements for which it would be currently impracticable to use metric units.BS3271:1970 BSI 02-2000 iii A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct appli

23、cation. 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 to iv, pages1to10, an inside back cover and a back cover. This standard has been updated (see copyright date) a

24、nd may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS3271:1970 BSI 02-2000 1 1 Scope This British Standard specifies the materials used in the manufacture of component parts of surgical elastic band trusses, together with such dim

25、ensions as are independent of the individual clinical requirements. Provision is made for inguinal and scrotal elastic band trusses with fixed pads or adjustable pads (excluding sliding pads). Requirements are included for woven webbing materials for use in the fabrication of elastic band trusses. P

26、rovision is made for elastic webbing of nominal 44 mm (1 3 / 4in) and 19 mm ( 3 / 4in) widths, and non-elastic webbing of nominal19mm width. 2 Terminology The following terms are employed in describing some of the components: 1) Elastic band. 2) Buckle shield, also known as flap or tongue, protectin

27、g the fastening buckle. 3) Shield inner covering, also known as inner lining. The covering of the shield situated nearest to the patients body. 4) Shield outer covering, also known as top leather. The covering of the shield situated away from the patients body. 5) Pad. That part controlling the hern

28、ia or rupture, and comprising: a) Outer face covering, also known as outer covering, head leather or top leather. The covering situated away from the patients body. b) Felling piece. Material stitched beneath the outer face covering to enable this to be stitched to the inner face covering. c) Plate

29、cover. Material encasing the plate. d) Plate. Metal foundation for the pad. e) Core of the pad. Contoured mound situated on the inner face of the plate. f) Padding. Material buffering the core of the pad from the patients body. g) Inner face covering, also known as pad cover, inner covering or inner

30、 lining. Material which is situated next to the patients body. 6) Pad spacer. A short length of material, as used for the elastic band, fixed between the pads on a double, fixed pad truss. 7) Understrap. Otherwise known as perineal strap, leg strap, groin strap or tail. A narrow component which pass

31、es between the patients legs linking the lower portion of the pad to the body band at the rear of the truss. The linkage to the pad, or to the band or both, should permit for length adjustment. 8) Tailstrap. Short length of elastic webbing being the termination of the understrap. 3 General requireme

32、nts for all metal components Metal components shall be free from defects, shall be cleanly finished, and all sharp edges shall be removed. 4 Plate 4.1 Material. The plate shall be made of commercial mild steel, such as grades CR4, CS4, HR4 or HS4 specified in BS 1449-1 1) , or alternatively of alumi

33、nium in the quarter-hard or half-hard condition complying with the requirements of BS 1470 2)SIC. 4.2 Thickness. If made of steel, the thickness of the plate shall be 1.2 mm to 1.6 mm (0.47 in to0.063in) to give adequate strength to meet the requirements of the patient, except that for plates of ver

34、y small sizes required for trusses for babies, a plate thickness of 0.9 mm (0.036 in) may be employed. If made of aluminium, the thickness of the plate shall be not less than 1.60 mm (0.063 in). 4.3 Manufacture. The plate shall be made in one piece and shall be slightly domed by pressing or beating.

35、 4.4 Screw threads. Fixing holes in the plates shall be drilled and tapped with M4.0 or M3.5 screw threads as appropriate (see Clause 7.). 4.5 Bushes or backing plates for fitting screws. Plates made of aluminium for use with adjustable pads with screw attachment, shall be fitted with nickel or cadm

36、ium plate brass bushes attached to the plate or with a metal backing plate to increase the thickness around the screw holes, secured with two rivets. For aluminium plates, the depth of the thread to receive the screw shall be not less than 3.2 mm ( 1 / 8in) see (also 24.3). 1) BS 1449, “Steel plate,

37、 sheet and strip”, Part 1, “Specification for carbon and carbon-manganese plate, sheet and strip”. 2) BS 1470, “Wrought aluminium and aluminium alloys for general engineering purposes. Sheet and strip”.BS3271:1970 2 BSI 02-2000 5 Rivets On fixed pad trusses or in the case of separate understraps, th

38、e attachment of the plate to the elastic webbing shall be by means of tubular or bifurcated rivets made of nickel plated steel and of3.2mm( 1 / 8in) nominal diameter. The nominal length of bifurcated rivets shall be not less than10mm( 3 / 8in). 6 Eyelets Eyelets shall be made of nickel or cadmium pl

39、ated brass of4.8mm ( 3 / 16in) bore, 9.5 mm ( 3 / 8in) external diameter and of suitable length to ensure a secure fitting. Eyelets specified in BS 3102 3)are suitable. Eyelets shall be fitted by machine pressing. 7 Screws 7.1 Design. Adjustable pads shall be fitted by means ofM4.0 orM3.5 raised-cou

40、ntersunk head screws of not less than 12.0 mm nominal length with ISO metric screw threads 4) , normal class fit, in accordance with BS 4183 5) . 7.2 Material. Screws shall be made from free machining brass rod complying with the requirements of BS 2874 6) , of stainless steel complying with the req

41、uirements of BS1554 7) ,420S37 or 431S29, or of carbon steel. 7.3 Finish. Screws shall be cleanly finished. Screws made of brass or of carbon steel shall be nickel plated and polished, or cadmium plated and polished. 8 Buckles and other fastening equipment 8.1 Material. Buckles and other fastening e

42、quipment shall have a nickel plated finish. 8.2 Elastic band. The elastic band shall be fastened by means of a 3-prong protected point buckle and shall also have a quick release catch plate. 8.3 Understrap. The understrap shall be fastened by means of a 2-prong protected point buckle. 9 Elastic band

43、 The elastic band shall be 44 mm (1 3 / 4in) wide woven elastic webbing of the quality specified in Appendix A. The free end of the elastic band shall be shaped to a radius or a point which shall be bound with a fabric binding tape, or over-stitched, or sealed with a suitable latex adhesive. 10 Cove

44、ring of the angled portion of the joint of the elastic band The inner and outer face coverings of the angled portion of the joint of the elastic band for trusses with detachable pads shall be made of undyed soft leather, or strained basil leather which shall be in accordance with Appendix B. 11 Buck

45、le shield The buckle on the body band shall be protected by means of a shield to prevent contact and pressure from the buckle during wear. The buckle shield shall be of a shape and of an area to overlap the buckle by at least 6 mm ( 1 / 4in) at all parts. The inner and outer coverings of the buckle

46、shield shall be made of undyed soft leather, strained basil leather or semi-soft natural hide which shall be in accordance with Appendix B. 12 Outer face covering of pad The outer face covering of the pad shall be textile material complying with the requirements specified for the inner face covering

47、 in Clause 17 or natural strained basil leather in accordance with Appendix B. 13 Felling piece The felling piece, if provided, shall be made of soft chamois leather or of soft gloving leather of suitable quality in accordance with Appendix B. 14 Plate cover The plate cover where used shall be made

48、of calico of suitable quality, or cotton cloth complying with the requirements specified in Clause 17 for the inner face covering. 15 Core of the pad 15.1 Material. The core of the pad shall be made of material selected to suit the requirements of the patient and shall be one of the following: 1) Ru

49、bber or suitable plastics materials. 3) BS 3102, “Brass eyelets and washers for general purposes”. 4) During the transition period for general adoption of the metric system in UK, screws and bosses having 3BA or 4 BA threads, as appropriate, may be used in accordance with BS 57, “B.A. screws, bolts and nuts”. 5) BS 4183, “Machine screws and machine screw nuts metric series”. 6) BS 2874, “Specification for copper and copper alloy rods and sections (other than forging stock)”. 7) BS 1554, “Specification for stainless and heat-resisting steel round wire”.BS3