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1、BRITISH STANDARD BS 3507:1976 Specification for Orthodontic wire and tape and dental ligature wire UDC 616.314 089.23:669.14.018.8 476 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3507:1976 This British Standard, having been prepared u
2、nder the direction of the Dental Industry Standards Committee, was published under the authority of the Executive Board on 30 April 1976 BSI 10-1999 First published June 1962 First revision April 1976 The following BSI references relate to the work on this standard: Committee reference DNS/1/4 Draft
3、 for comment 75/60059 DC ISBN 0 580 09442 1 Co-operating organizations The Dental Industry Standards Committee, under whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional organizations: Association of Dental Hosp
4、itals of Great Britain and Northern Ireland British Dental Association British Dental Trade Association Dental Education Advisory Council Department of Health and Social Security* Department of Trade and Industry-Laboratory of the Government Chemist* Department of Trade and Industry-National Enginee
5、ring Laboratory Ministry of Defence Royal Society of Medicine Scottish Home and Health Department The Government departments marked with an asterisk in the above list, together with the following, were directly represented on the committee entrusted with the preparation of this standard: British Ins
6、titute of Surgical Technicians British Society for the Study of Orthodontics British Steel Industry Dental Laboratories Association Amendments issued since publication Amd. No.Date of issueComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Copy, (c)
7、 BSI BS 3507:1976 BSI 10-1999i Contents Page Co-operating organizationsInside front cover Forewordii 1Scope1 2References1 3General1 4Hard drawn wire1 5Extra hard drawn wire2 6Multi-strand wire2 7Orthodontic stainless steel tape3 8Ligature wire (soft wire) for use in dentistry3 9Test methods3 10Marki
8、ng4 Figure 1 Diagram illustrating suitable apparatus for determination of resistance to failure on bending4 Table 1 Hard drawn wire. Size range and tensile strength1 Table 2 Hard drawn wire. Resistance to failure on bending1 Table 3 Extra hard drawn steel wire. Size range2 Table 4 Extra hard drawn s
9、teel wire. Resistance to failure on bending2 Table 5 Multi-strand wire. Size range2 Table 6 Minimum elastic radius2 Table 7 Ligature wire (soft wire). Size range3 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Co
10、py, (c) BSI BS 3507:1976 ii BSI 10-1999 Foreword This British Standard was prepared under the authority of the Dental Industry Standards Committee as part of a programme for preparation of standards relating to dental materials, instruments and equipment. The purpose of the specification is to stand
11、ardize a range of sizes and to specify the quality of wire and tape used for orthodontics, particularly in relation to strength and ductility, and in this respect little has changed since publication of the first edition in 1962. A number of developments in orthodontic techniques have, however, take
12、n place and these, together with the increase in experience pertaining to the testing of the wires and tapes, have prompted the present complete revision of this standard. The use of multi-strand wires in orthodontics has become much more popular in the UK during recent years and sufficient data on
13、their physical characteristics have now been obtained to include a separate section giving relevant performance and dimensional requirements. These wires have certain very special properties, and a new approach to testing has been developed to give the type of information that is of significance in
14、their clinical application. Because of the continuing use of a wide variety of tape sizes, it has been decided that consumer interest would be served best by omitting any specific range of nominal dimensions and requiring only that the sizes stated by the manufacturer conform to certain limits on to
15、lerance. The introduction of new corrosion-resistant alloys for use in orthodontics is now a very real possibility. With this in mind the various references to stainless steel, which formed part of the previous edition of this standard, have been modified to permit the use of alternative alloys. Thr
16、oughout this British Standard, SI units and their multiples and submultiples have been used. Information on the International System of units (SI) is given in BS 3763 “The International System of units (SI)” and PD 5686 “The use of SI units”. Tables of conversion are given in Supplement No. 1 “Addit
17、ional tables for SI conversions” to BS 350 “Conversion factors and tables Part 2 “Detailed conversion tables”. 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 Britis
18、h 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 4, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments in
19、corporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3507:1976 BSI 10-19991 1 Scope This British Standard relates to a) hard drawn wire for orthodontic use; b
20、) extra hard drawn wire for orthodontic use; c) multi-strand wire for orthodontic use; d) tape for orthodontic use; e) soft wire (ligature wire) for use in dentistry. 2 References The titles of the British Standards referred to in this standard are listed on the inside back cover. 3 General 3.1 Defe
21、cts. The wire or tape shall be manufactured in accordance with good practice and shall be free from harmful defects such as seams and laps. 3.2 Coils. Wire supplied in coils shall lie flat without any substantial corkscrew set. 3.3 Weldability. If the wire or tape is not suitable for welding this sh
22、all be clearly indicated. 4 Hard drawn wire 4.1 Materials. The wire shall be made from a suitable austenitic stainless steel that has a chromium content of not less than 13 % by mass, or an alloy other than stainless steel of suitable corrosion resistance. NOTEGrade 302S25 stainless steel specified
23、in BS 970-4 would be suitable. If an alloy other than stainless steel is used, the manufacturer shall be able to produce, on request, evidence of adequate clinical trials having been carried out to establish the alloys suitability for use in the oral environment. 4.2 Size range. The diameter shall b
24、e designated in millimetres and the size range shall be in accordance with Table 1. 4.3 Tensile strength. When tested in accordance with BS 4545, the tensile strength shall be in accordance with Table 1 of this standard. 4.4 Resistance to failure on bending. When tested in accordance with the method
25、 described in clause 9, hard drawn wire shall withstand without breaking the number of complete bending cycles specified in Table 2. 4.5 Condition. The wire shall be in the cold drawn condition. 4.6 Finish. The wire shall have a clean smooth finish. Table 1 Hard drawn wire. Size range and tensile st
26、rength Table 2 Hard drawn wire. Resistance to failure on bending DiameterToleranceTensile strength mmmmN/mm2 1.5 1.25 1.15 0.025 1 500 to 1 700 1.0 0.9 0.8 0.0121 700 to 1 900 0.7 0.6 0.5 0.0121 850 to 2 050 0.45 0.4 0.35 0.30 0.012 0.012 0.012 0.006 2 000 to 2 200 0.25 0.20 0.15 0.0062 200 to 2 400
27、 SizeDeflection from zero position, angle (see Figure 1) Minimum number of bending cycles mmdegrees 1.5 1.25 1.15 304 1.0 0.9 0.8 0.7 3012 0.6 0.5 0.45 0.4 0.35 0.3 4015 0.25 0.20 0.15 4020 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
28、3507:1976 2 BSI 10-1999 5 Extra hard drawn wire 5.1 Material. The wire shall be made from a suitable austenitic stainless steel that has a chromium content of not less than 13 % by mass, or an alloy other than stainless steel of suitable corrosion resistance. NOTEGrade 302S25 stainless steel specifi
29、ed in BS 970-4 would be suitable. If an alloy other than stainless steel is used, the manufacturers shall be able to produce, on request, evidence of adequate clinical trials having been carried out to establish the alloys suitability for use in the oral environment. 5.2 Size range. The diameter sha
30、ll be designated in millimetres and the size range shall be in accordance with Table 3. 5.3 Tensile strength. When tested in accordance with BS 4545, the tensile strength of extra hard drawn wire shall be not less than 2 500 N/mm2. 5.4 Resistance to failure on bending. When tested in accordance with
31、 the method described in clause 9, extra hard drawn wire shall withstand without breaking the number of complete bending cycles specified in Table 4 (see also 9.1.3). 5.5 Condition. The wire shall be in the cold drawn condition. 5.6 Finish. The wire shall have a clean smooth finish. Table 3 Extra ha
32、rd drawn steel wire. Size range Table 4 Extra hard drawn steel wire. Resistance to failure on bending 6 Multi-strand wire 6.1 Formation. Multi-strand wire shall be formed from a number of individual strands evenly twisted together. A non-toxic adhesive may be used. When the wire is cut, the individu
33、al strands shall not unravel. 6.2 Material. The wire shall be made from a suitable austenitic stainless steel that has a chomium content of not less than 13 % by mass, or an alloy other than stainless steel of suitable corrosion resistance. NOTEGrade 302S25 stainless steel specified in BS 970-4 woul
34、d be suitable. If an alloy other than stainless steel is used, the manufacturer shall be able to produce, on request, evidence of adequate clinical trials having been carried out to establish the alloys suitability for use in the oral environment. 6.3 Size range. The effective diameter1) shall be de
35、signated in millimetres and the size range shall be in accordance with Table 5. 6.4 Flexural rigidity. When tested in accordance with 9.2, the flexural rigidity of a wire shall be within 10 % of the value stated by the manufacturer (see 10.2). 6.5 Minimum elastic radius. When tested in accordance wi
36、th 9.3 the radius of the mandrel round which a suitable length of wire may be wrapped without acquiring a permanent set shall be not greater than that stated in Table 6 for the relevant wire diameter. 6.6 Finish. The wire shall be supplied in straight lengths that show no significant spiral. Table 5
37、 Multi-strand wire. Size range Table 6 Minimum elastic radius DiameterTolerance mmmm 0.55 0.50 0.45 0.40 0.35 0.30 0.012 SizeDeflection from zero position, angle (see Figure 1) Minimum number of bending cycles mmdegrees 0.55 0.50 0.45 0.40 0.35 0.30 4015 1) Effective diameter is the internal diamete
38、r of the smallest tube through which the wire would pass. DiameterTolerance mmmm 0.55 0.50 0.45 0.40 0.375 + 0 0.025 DiameterRadius of mandrel mmmm 0.55 0.50 0.45 0.40 0.375 20 15 12 11 10 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:22:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3
39、507:1976 BSI 10-19993 7 Orthodontic stainless steel tape 7.1 Material. The tape shall be made from a suitable austenitic stainless steel that has a chromium content of not less than 13 % by mass or an alloy other than stainless steel of suitable corrosion resistance. 7.2 Size range. The size (width
40、and thickness) shall be designated in millimetres and shall be within the following tolerances: a) width b) thickness 7.3 Tensile strength. When tested in accordance with BS 4545, the tensile strength of the tape shall be not more than 850 N/mm2. 7.4 Condition. The tape shall be in the fully softene
41、d condition. 7.5 Finish. The tape shall have a high polish on one side and a clean smooth finish on the other side. 8 Ligature wire (soft wire) for use in dentistry The composition and performance requirements for ligature wire described in this clause are intended to cover its application to “non-s
42、urgical” procedures. Ligature wire used in a submucous or subcutaneous situation becomes, in practical terms, an implant and as such there are obviously a number of other special qualities that this specification would have to take into account, were it intended to be applied to wires used for such
43、purposes. 8.1 Material. The material shall comply with the formulation of 304S15 or 316S16 stainless steel specified in BS 970-4, or be an alloy other than stainless steel of suitable corrosion resistance. If any alloy other than stainless steel is used, the manufacturer shall be able to produce, on
44、 request, evidence of adequate clinical trials having been carried out to establish the alloys suitability for use in the oral environment. 8.2 Size range. The diameter shall be designated in millimetres and the size range shall be in accordance with Table 7. Table 7 Ligature wire (soft wire). Size
45、range 8.3 Tensile strength. When tested in accordance with BS 4545 and using a test specimen of 250 mm gauge length, the tensile strength of the wire shall be not more than 850 N/mm2. The elongation shall be not less than 30 %. 8.4 Condition. The wire shall have a clean smooth surface and be in the
46、fully softened condition. 9 Test methods 9.1 Determination of resistance to failure on bending. 9.1.1 Apparatus. An apparatus of the type illustrated in Figure 1, which can be used for gripping a wire test piece and bending it through a specified angle. The apparatus illustrated comprises a) a vice
47、with the upper edges of the jaws radiused to 0.5 mm; b) a protractor scale which can be used for measuring the bending angle; c) a pin vice. 9.1.2 Procedure. Use a wire test piece of approximately 7 mm length and grip one end firmly in the pin vice so that at least 4 mm of wire is left exposed. Grip
48、 this exposed wire firmly in the jaws of the vice so that the distance between the top surface of the vice and the end of the (pin vice) chuck is 1.0 mm as set by a slotted slip gauge. Starting with the specimen upright in a position of zero deflection, bend first left and then right to the relevant
49、 angle specified in Table 2 or Table 4. The cycle from left deflection to right and back to left again shall constitute one bending cycle. Carry out this bending at a rate of half a cycle per second and in such a manner as to prevent rotation and collapse of the specimen. up to and including 8.0 mm 0.1 mm above 8.0 mm 0.125 mm up to and including 0.15 mm 0.004 mm above 0.15 mm 0.006 mm DiameterTolerance mmmm 0.70 0.60 0.50 0.45 0.40 0.012 0.30 0.25 0.20 0.15 0.006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 2