BS 3531-6 1-1990 Implants for osteosynthesis - Skeletal pins and wires - Specification for general requirements《骨接合术用外科植入物 第6部分 骨骼用钉和金属丝 第1节 一般要求规范》.pdf

1、BRITISH STANDARD BS3531-6.1: 1990 Implants for osteosynthesis Part6: Skeletal pins and wires Section6.1 Specification for general requirementsBS3531-6.1:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee waspublished under the authorityo

2、f the Board of BSI comes into effect on 31August1990 BSI09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft announced in BSI News, October1989 ISBN 0 580 18993 7 Committees responsible for this British Standard The preparation of this British St

3、andard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/22, upon which the following bodies were represented: British Institute of Surgical Technologists British Investment Casting Trade Association British Medical Association British Orthopaedic Associa

4、tion British Steel Industry British Surgical Trades Association Incorporated Department of Health Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Sco

5、ttish Office Coopted members Amendments issued since publication Amd. No. Date of issue CommentsBS3531-6.1:1990 BSI 09-1999 i Contents Page Committees responsible Inside front cover Foreword ii Section 1. General 1 Scope 1 2 References 1 3 Materials 1 4 Finish 2 5 Packaging 2 6 Marking of implants 2

6、 Section 2. Skeletal pins 7 Dimensions 2 8 Point 2 9 Head of shank 2 Section 3. Skeletal wires 10 Diameter 2 Section 4. Guide wires 11 Diameter 2 12 Ends 2 13 Graduation marks 2 Section 5. Fixation and threaded pins or wires 14 Dimensions 2 15 Ends 3 16 Nuts 3 Appendix A Information to be supplied b

7、y the purchaser 4 Table 1 Tensile strength of wires made of austenitic stainless steel 1 Table 2 Skeletal pins (e.g. Steinmann pins) 2 Publications referred to Inside back coverBS3531-6.1:1990 ii BSI 09-1999 Foreword This Section of BS3531 has been prepared under the direction of the Health Care Sta

8、ndards Policy Committee and supersedes BS3531-6:1982, which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants”) were first published in1962 as BS3531. In 1968 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with surgical implants made of all mater

9、ials. In1980 the first four Parts of a multi-part version of BS3531 were published. A further19 Parts of BS3531 were subsequently published, Part6:1982 giving requirements for skeletal pins and wires. In view of the increase in the number of Parts, and with a view to facilitating the implementation

10、of published or forthcoming ISO implant standards, the British Standard relating to implants has been restructured. Accordingly, the number BS3531 is reserved for standards for implants for osteosynthesis, BS7251 covers joint prostheses, BS7252 covers metallic materials for surgical implants, BS7253

11、 covers non-metallic materials for surgical implants and BS7254 covers orthopaedic implants i.e.aspects common to both osteosynthesis and joint replacement. This Section of BS3531 introduces editorial changes to reflect this restructuring and up-dates cross-references but otherwise makes no changes

12、to the specification for skeletal pins and wires first published as BS3531-6:1982 and amended in October1983. It does not reflect a full review or revision of the standard which will be undertaken in due course. Metal wires are used in orthopaedic surgery in a variety of ways, for methods of skeleta

13、l traction, for compression arthrodesis, for fixation of fractures, and as guide wires in the insertion of other internal fixation devices. It has been found in clinical practice and in laboratory studies that wires used in these ways are performing close to or beyond the elastic limits of the mater

14、ials at present available, and caution should be used when relying on these devices. Once implantation has been completed, an implant should never be reused after removal. It is strongly recommended that the products specified in this Section of BS3531-6 should be manufactured according to the recom

15、mendations given in the “Guide to Good Manufacturing Practice for Orthopaedic Implants” 1) . Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continued sur

16、veillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availability of third party certification schemes will be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does

17、 not already exist, users should consider approaching an appropriate body from the list of Association members. 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 Briti

18、sh Standard 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 incor

19、porated. This will be indicated in the amendment table on the inside front cover. 1) Compiled by the Department of Health and Social Security; published and available from Her Majestys Stationery Office. ISBN 011 320846 4.BS3531-6.1:1990 BSI 09-1999 1 Section 1. General 1 Scope This Section of BS353

20、1 specifies basic requirements for skeletal pins and wires, made of wrought austenitic stainless steel, wrought cobalt-chromium-tungsten-nickel alloy or of wrought titanium alloy, used in orthopaedic surgery. Provision is made for: a) skeletal pins used for skeletal traction and in compression clamp

21、s, e.g.Steinmann pins; b) skeletal wires used for skeletal traction and fixation, e.g.Kirschner wires; c) guide wires used to aid the insertion of other devices such as cannulated hip nails; d) fixation and threaded pins and wires, used for the fixation of displaced upper femoral epiphysis or in the

22、 treatment of fractures. 2 References The titles of publications referred to in this standard are listed on the inside back cover. 3 Materials 3.1 General. Pins and wires shall be made of austenitic stainless steel, wrought cobalt-chromium-tungsten-nickel alloy or wrought titanium alloy, in accordan

23、ce with3.2 to3.4. 3.2 Austenitic stainless steel 3.2.1 Composition. The material used in making skeletal pins and wires shall be in accordance with composition D or E of BS7252-1 or in accordance with BS7252-9, and shall meet the requirements of the intergranular corrosion test. 3.2.2 Condition. The

24、 wire shall be in the cold drawn condition, but may have received stress relieving heat treatment at a temperature not exceeding450 C. 3.2.3 Tensile strength. When tested in accordance with BS4545, the tensile strength in the as-drawn (coiled) condition and after straightening shall be as given in T

25、able 1. Table 1 Tensile strength of wires made of austenitic stainless steel 3.2.4 Elongation. When tested in accordance with BS4545, the elongation shall be as given in Table 1. 3.2.5 Intergranular corrosion. When tested in accordance with BS5903:1980, finished wires and pins shall be found satisfa

26、ctory according to the criteria given in clause10 of that standard. The wire or pin shall not be heated prior to testing. 3.3 Wrought cobalt-chromium-tungsten-nickel alloy 3.3.1 Composition. The material used in making skeletal pins and wires shall be in accordance with BS7252-5. 3.3.2 Condition. Th

27、e wire shall be in the cold drawn condition, but may have received stress relieving heat treatment in an inert atmosphere. 3.3.3 Tensile strength. When tested in accordance with BS18 using a gauge length of2002mm, the tensile strength shall be not less than1280MPa. 3.3.4 Elongation. When tested in a

28、ccordance with BS18 using a gauge length of200 2mm, the elongation shall be not less than7.0%. 3.4 Titanium alloy 3.4.1 Composition. Wire made of titanium alloy shall be in accordance with the requirements specified in BS7252-3 excluding requirements for tensile strength and elongation for which the

29、 provisions of3.4.3 and3.4.4 shall apply. 3.4.2 Condition. The wire shall be in the cold drawn condition and centreless ground. 3.4.3 Tensile strength. When tested in accordance with BS18 using a gauge length of2002mm, the tensile strength shall be within the range1150MPa to1400MPa. 3.4.4 Elongation

30、. When tested in accordance with BS18 using a gauge length of200 2mm, the elongation shall be not less than3%. Diameter Minimum tensile strength Minimum elongation As-drawn (coiled) condition Straightened condition mm MPa MPa % 1.00 1.60 2.00 2.50 3.15 4.00 4.80 6.30 1550 1550 1550 1550 1400 1400 14

31、00 1240 1400 1400 1400 1400 1325 1240 1240 1120 3 3 3 3 5 5 5 5BS3531-6.1:1990 2 BSI 09-1999 4 Finish There shall be no longitudinal or circumferential marks when observed under 2“ magnification in good lighting conditions by normal or corrected vision. Pointed ends shall be free from feather edges,

32、 burrs, hooks and other defects. NOTESee Appendix A for information to be given by the purchaser with regard to the finish of wires and pins. 5 Packaging Skeletal pins and wires shall be packaged and labelled in accordance with BS7254-1. 6 Marking of implants Wherever possible, skeletal pins and wir

33、es shall be permanently marked at one end with the following: a) the diameter designated in millimetres; b) the name or trademark of the manufacturer; c) the number of this British Standard, i.e.BS3531-6.1 2) . Where this is not possible due to the small diameter of the wire, the manufacturers trade

34、 mark only shall be used. Section 2. Skeletal pins (e.g.Steinmannpins) 7 Dimensions 7.1 Diameter. The diameter shall be designated in millimetres and the size range and tolerances shall be in accordance with Table 2. 7.2 Length. The length shall be designated in millimetres. The size range shall be

35、as given in Table 2. Table 2 Size range of skeletal traction pins 8 Point Pins shall have a trochar point or a diamond point not exceeding the diameter of the pin. The included angle of the point shall be30 5 . 9 Head of shank The end of the pin opposite the point shall have a three-faced shank, sui

36、table for fitting to a three-jawed chuck. The length of this shank shall be not less than15mm. Section 3. Skeletal wires (e.g.Kirschnerwires) 10 Diameter The diameter shall be designated in millimetres. The range shall comprise the following:1.0mm,1.6mm and2.0mm. There shall be a tolerance of 0.04mm

37、. NOTESee Appendix A for information to be supplied by the purchaser with regard to length and end type of wires. Section 4. Guide wires 11 Diameter Guide wires shall have a diameter of2.5 0.04mm. NOTESee Appendix A for information to be supplied by the purchaser with regard to length of wire. 12 En

38、ds One end of the wire shall be flat. The other end shall have a point that shall be either: a) of the trochar pattern not exceeding the diameter of the wire and with three faces set at an angle of30 5 ; or b) a diamond point with an angle of45 . 13 Graduation marks Guide wires shall be graduated at

39、 intervals of10mm. The graduation lines shall be permanently marked by any method which does not introduce a stress raiser or degrade the wire, e.g.by an air-blasting technique using iron-free grit. Section 5. Fixation and threaded pins or wires 14 Dimensions 14.1 Diameter. The diameter shall be des

40、ignated in millimetres. There shall be two sizes, namely2.5mm or3.15mm. 14.2 Length. Pins shall be of length in the range90mm to130mm in10mm steps. 2) Marking BS3531-6.1 on or in relation to a product represents a manufacturers declaration of conformity, i.e.a claim by or on behalf of the manufactur

41、er that the product meets the requirements of the standard. The accuracy of the claim is therefore solely the 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. Diameter Tolerance Length m

42、m mm mm 2.50 3.15 4.00 4.80 0.04 0.04 0.04 0.04 200 200 200 250BS3531-6.1:1990 BSI 09-1999 3 15 Ends The point shall be conical or trochar in shape having a diameter not greater than the diameter of the pin. The end opposite to the point shall be either: a) a three-faced shank suitable for fitting i

43、n a three-jawed chuck with the length of the shank being not less than15mm; or b) threaded with M2.5 0.45 or M3 0.5 medium class fit ISO metric screw threads. 16 Nuts Nuts for use with threaded pins shall have an external form of the hexagon type in accordance with M5 size ISO metric nuts, with a wi

44、dth across the flats of8mm. The internal thread of the nut shall conform with the thread on the appropriate pin.BS3531-6.1:1990 4 BSI 09-1999 Appendix A Information to be supplied by the purchaser A.1 Finish Wires and pins are usually supplied in a polished condition and finished in accordance with

45、BS7254-2. In instances where this is not suitable, the purchaser should specify the type of finish required. A.2 Skeletal wires A.2.1 Length. Skeletal wires are usually supplied in lengths of250mm. Where different lengths are required, they should be specified by the purchaser. A.2.2 Ends. Skeletal

46、wires are usually supplied with trochar or diamond points, having an included angle of45 , at one or both ends. The purchaser should specify whether one or both ends of the wire are to have a point and the type of point(s) required. A.3 Guide wires Guide wires are usually supplied in lengths of230mm

47、. Where other lengths are required, they should be specified by the purchaser.BS3531-6.1:1990 BSI 09-1999 Publications referred to BS18, Methods for tensile testing of metals (including aerospace materials). BS3531, Implants for osteosynthesis 3) . BS4545, Methods for mechanical testing of steel wir

48、e. BS5750, Quality systems 3) . BS5903, Method for determination of resistance to intergranular corrosion of austenitic stainless steels:copper sulphate sulphuric acid method (Moneypenny Strauss test). BS7251, Orthopaedic joint prostheses 3) . BS7252, Metallic materials for surgical implants. BS7252

49、-1, Specification for wrought stainless steel. BS7252-3, Specification for wrought titanium 6-aluminium 4-vanadium alloy. BS7252-5, Specification for wrought cobalt-chromium-tungsten-nickel alloy. BS7252-9, Specification for high-nitrogen stainless steel. BS7253, Non-metallic materials for surgical implants 3) . BS7254, Orthopaedic implants. BS7254-1, Specification for marking, packaging and labelling. BS7254-2, Specification for general requirements for materials and finish. 3) Referred to in the foreword only.BS3531-6.1: 1990 BSI 389