BS 3507-1976 Specification - Orthodontic wire and tape and dental ligature wire《整牙线带及牙科用结扎线规范》.pdf

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1、BRITISH STANDARD BS 3507:1976 Specification for Orthodontic wire and tape and dental ligature wire UDC 616.314089.23:669.14.018.8476BS3507:1976 This British Standard, having been prepared under the directionof the Dental Industry Standards Committee, was published under the authority ofthe Executive

2、 Board on 30April1976 BSI 10-1999 First published June1962 First revision April1976 The following BSI references relate to the work on this standard: Committee reference DNS/1/4 Draft for comment75/60059 DC ISBN 0 580 09442 1 Co-operating organizations The Dental Industry Standards Committee, under

3、whose supervision this British Standard was prepared, consists of representatives from the following Government departments and professional organizations: Association of Dental Hospitals of Great Britain and Northern Ireland British Dental Association British Dental Trade Association Dental Educati

4、on Advisory Council Department of Health and Social Security* Department of Trade and Industry-Laboratory of the Government Chemist* Department of Trade and Industry-National Engineering Laboratory Ministry of Defence Royal Society of Medicine Scottish Home and Health Department The Government depar

5、tments 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 Institute of Surgical Technicians British Society for the Study of Orthodontics British Steel Industry Dental Laboratorie

6、s Association Amendments issued since publication Amd. No. Date of issue CommentsBS3507:1976 BSI 10-1999 i Contents Page Co-operating organizations Inside front cover Foreword ii 1 Scope 1 2 References 1 3 General 1 4 Hard drawn wire 1 5 Extra hard drawn wire 2 6 Multi-strand wire 2 7 Orthodontic st

7、ainless steel tape 3 8 Ligature wire (soft wire) for use in dentistry 3 9 Test methods 3 10 Marking 4 Figure 1 Diagram illustrating suitable apparatus fordeterminationofresistance to failure on bending 4 Table 1 Hard drawn wire. Size range and tensile strength 1 Table 2 Hard drawn wire. Resistance t

8、o failure on bending 1 Table 3 Extra hard drawn steel wire. Size range 2 Table 4 Extra hard drawn steel wire. Resistance to failure on bending 2 Table 5 Multi-strand wire. Size range 2 Table 6 Minimum elastic radius 2 Table 7 Ligature wire (soft wire). Size range 3 Publications referred to Inside ba

9、ck coverBS3507:1976 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 standardiz

10、e 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 in1962. A number of developments in orthodontic techniques have, however, taken plac

11、e 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 their

12、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 their

13、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 toleranc

14、e. 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. Throughou

15、t this British Standard, SI units and their multiples and submultiples have been used. Information on the International System of units (SI) is given in BS3763 “The International System of units (SI)” and PD5686 “The use of SI units”. Tables of conversion are given in Supplement No.1 “Additional tab

16、les for SI conversions” to BS350 “Conversion factors and tables Part2 “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 British Standard

17、does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 to4, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. Thi

18、s will be indicated in the amendment table on the inside front cover.BS3507:1976 BSI 10-1999 1 1 Scope This British Standard relates to a) hard drawn wire for orthodontic use; b) extra hard drawn wire for orthodontic use; c) multi-strand wire for orthodontic use; d) tape for orthodontic use; e) soft

19、 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 Defects. The wire or tape shall be manufactured in accordance with good practice and shall be free from harmful defects such as

20、 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 shall be clearly indicated. 4 Hard drawn wire 4.1 Materials. The wire shall be made from a suitable austenitic stainless stee

21、l that has a chromium content of not less than13% by mass, or an alloy other than stainless steel of suitable corrosion resistance. NOTEGrade302S25 stainless steel specified in BS970-4 would be suitable. If an alloy other than stainless steel is used, the manufacturer shall be able to produce, on re

22、quest, 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 be designated in millimetres and the size range shall be in accordance with Table 1. 4.3 Tensile strength. When tested in accord

23、ance with BS4545, 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 described in clause9, hard drawn wire shall withstand without breaking the number of complete bending cycles specified in Table

24、 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 andtensile strength Table 2 Hard drawn wire. Resistance to failure on bending Diameter Tolerance Tensile strength mm mm N/mm 2 1.5 1.25 1.15 0.

25、025 1500to1700 1.0 0.9 0.8 0.012 1700to1900 0.7 0.6 0.5 0.012 1850to2050 0.45 0.4 0.35 0.30 0.012 0.012 0.012 0.006 2000to2200 0.25 0.20 0.15 0.006 2200 to2400 Size Deflection from zero position, angle (seeFigure 1) Minimum number of bending cycles mm degrees 1.5 1.25 1.15 30 4 1.0 0.9 0.8 0.7 30 12

26、 0.6 0.5 0.45 0.4 0.35 0.3 40 15 0.25 0.20 0.15 40 20BS3507:1976 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 than13% by mass, or an alloy other than stainless steel of suitable corrosion

27、 resistance. NOTEGrade302S25 stainless steel specified in BS970-4 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

28、 oral environment. 5.2 Size range. The diameter shall be designated in millimetres and the size range shall be in accordance with Table 3. 5.3 Tensile strength. When tested in accordance with BS4545, the tensile strength of extra hard drawn wire shall be not less than2500N/mm 2 . 5.4 Resistance to f

29、ailure on bending. When tested in accordance with the method described in clause9, extra hard drawn wire shall withstand without breaking the number of complete bending cycles specified in Table 4 (seealso9.1.3). 5.5 Condition. The wire shall be in the cold drawn condition. 5.6 Finish. The wire shal

30、l have a clean smooth finish. Table 3 Extra hard drawn steelwire.Sizerange 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

31、be used. When the wire is cut, the individual 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 than13% by mass, or an alloy other than stainless steel of suitable corrosion resistance. NOTEGrade302S25 st

32、ainless steel specified in BS970-4 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. 6.3 Size rang

33、e. The effective diameter 1)shall be designated in millimetres and the size range shall be in accordance with Table 5. 6.4 Flexural rigidity. When tested in accordance with9.2, the flexural rigidity of a wire shall be within 10% of the value stated by the manufacturer (see10.2). 6.5 Minimum elastic

34、radius. When tested in accordance with9.3 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

35、show no significant spiral. Table 5 Multi-strand wire. Size range Table 6 Minimum elastic radius Diameter Tolerance mm mm 0.55 0.50 0.45 0.40 0.35 0.30 0.012 Size Deflection from zero position, angle (seeFigure 1) Minimum number of bending cycles mm degrees 0.55 0.50 0.45 0.40 0.35 0.30 40 15 1) Eff

36、ective diameter is the internal diameter of the smallest tube through which the wire would pass. Diameter Tolerance mm mm 0.55 0.50 0.45 0.40 0.375 +0 0.025 Diameter Radius of mandrel mm mm 0.55 0.50 0.45 0.40 0.375 20 15 12 11 10BS3507:1976 BSI 10-1999 3 7 Orthodontic stainless steel tape 7.1 Mater

37、ial. The tape shall be made from a suitable austenitic stainless steel that has a chromium content of not less than13% by mass or an alloy other than stainless steel of suitable corrosion resistance. 7.2 Size range. The size (width and thickness) shall be designated in millimetres and shall be withi

38、n the following tolerances: a) width b) thickness 7.3 Tensile strength. When tested in accordance with BS4545, the tensile strength of the tape shall be not more than850N/mm 2 . 7.4 Condition. The tape shall be in the fully softened condition. 7.5 Finish. The tape shall have a high polish on one sid

39、e 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-surgical” procedures. Ligature wire used in a submucous or subcutaneou

40、s 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 purposes. 8.1 Material. The material shall comply with the formulatio

41、n of304S15 or316S16 stainless steel specified in BS970-4, 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 request, evidence of adequate clinical trials having been carried out t

42、o establish the alloys suitability for usein 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 range 8.3 Tensile strength. When tested in accordance with BS4545 and usi

43、ng a test specimen of250mm gauge length, the tensile strength of the wire shall be not more than850N/mm 2 . The elongation shall be not less than30%. 8.4 Condition. The wire shall have a clean smooth surface and be in the fully softened condition. 9 Test methods 9.1 Determination of resistance to fa

44、ilure 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 with the upper edges of the jaws radiused to0.5mm; b) a protractor scale which

45、 can be used for measuring the bending angle; c) a pin vice. 9.1.2 Procedure. Use a wire test piece of approximately7mm length and grip one end firmly in the pin vice so that at least4mm of wire is left exposed. Grip this exposed wire firmly in the jaws of the vice so that the distance between the t

46、op surface of the vice and the end of the (pin vice) chuck is1.0mm 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 angle specified in Table 2 or Table 4. The cycle from left deflection to right and ba

47、ck 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 including8.0mm 0.1mm above8.0mm 0.125mm up to and including0.15mm 0.004mm above0.15mm 0.006mm Diameter

48、Tolerance mm mm 0.70 0.60 0.50 0.45 0.40 0.012 0.30 0.25 0.20 0.15 0.006BS3507:1976 4 BSI 10-1999 9.1.3 Retests. If the original specimen selected does not pass this test, two further specimens representing the same batch shall be tested in the same manner. The wire shall be deemed to comply with th

49、e requirements of this specification only if both additional test specimens meet the relevant requirements. 9.2 Procedure for determining flexural rigidity (EI). Determine the flexural rigidity using a cantilever beam test as follows: Use a straight wire test piece of not less than120mm length and put a small V-shaped kink as near one end as possible. Clamp the other end in a rigid framework so that the wire is horizontal with the V kink vertical and its apex1001mm from the jaws of the clamp. Suspend a piece of wi