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1、BRITISH STANDARD BS 3531-5.5: 1990 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.5 Specification for taps and drills BS 3531-5.5:1990 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under
2、 the authority of the Board of BSI and comes into effect on 30 April 1990 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment 87/54793 ISBN 0 580 17918 4 Committees responsible for this British Standard The preparation of this Br
3、itish Standard 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
4、 Association 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 Col
5、lege Scottish Office Coopted members Amendments issued since publication Amd. No.Date of issueComments BS 3531-5.5:1990 BSI 10-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Twist drills1 3Taps1 4Marking1 5Packaging1 Figure 1 Twist drill nomenclature2 Table 1 Recomm
6、ended sizes of twist drills1 Publications referred toInside front cover BS 3531-5.5:1990 ii BSI 10-1999 Foreword This Section of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee. It partially supersedes BS 3531-5:1982 and comprises similar requirements for
7、the taps and drills that were previously specified in BS 3531-5:1982, which also contained requirements for particular types of bone screw, for screwdrivers and for holes and slots in bone plates. The revision of BS 3531-5 offered the opportunity to facilitate the implementation of published and for
8、thcoming International Standards, and to separate, in different Parts of BS 3531, requirements for screws and auxiliary equipment from those for bone plates. Accordingly therefore, requirements for bone screws and auxiliary equipment are retained in BS 3531-5, which is to be published in separate Se
9、ctions, whilst requirements for bone plates are specified in BS 3531-23, also to be published in Sections. BS 3531-5:1982 is withdrawn. The taps and drills specified in this Section of BS 3531 are suitable for use with the screws specified in BS 3531-5.4, and the requirements differ from those in BS
10、 3531-5:1982 only by permitting the use of two grades of stainless steel in place of the single grade in Part 5 which is now unobtainable. It is strongly recommended that the products specified in this Section of BS 3531 should be manufactured according to the recommendations given in the “Guide to
11、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 continuing surveillance, which may be coupled wit
12、h assessment of a suppliers quality systems against the appropriate Part of BS 5750. 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 not already exist, users should c
13、onsider 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 British Standard does not of itself con
14、fer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 and 2, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicat
15、ed 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 0 11 320846 4. BS 3531-5.5:1990 BSI 10-19991 1 Scope This Section of BS 3531 specifies general requirements for twist dr
16、ills and taps for use with bone screws specified in BS 3531-5.4. NOTEThe titles of the publications referred to in this standard are listed on the inside back cover. 2 Twist drills Twist drills shall be made of stainless steel of grades 420S37 or 302S31 in accordance with BS 970-1, or of cold worked
17、 wrought cobalt-chromium-tungsten-nickel alloy in accordance with BS 7252-5. NOTE 1The recommended diameters of the twist drills are given in Table 1. NOTE 2It is recommended that the point angle of the drill should be 130 C. Experimental evidence has indicated that optimum results may be obtained w
18、ith human bone by using a drill with a self-centering tip (e.g. having a spiral point and with cutting lands). NOTE 3Elements of the design and nomenclature relating to twist drills are given in Figure 1. Table 1 Recommended sizes of twist drills 3 Taps 3.1 Material Taps shall either be made of stai
19、nless steel of grades 420S37 or 302S31 in accordance with BS 970-1, or of cold worked wrought cobalt-chromium-tungsten-nickel alloy in accordance with BS 7252-5. 3.2 Design The thread form of taps shall correspond with the thread form of the appropriate screw specified in BS 3531-5.4. NOTESee BS 949
20、-1 for nomenclature and designation of dimensions of taps. 4 Marking 4.1 Twist drills Twist drills shall be permanently and legibly marked with at least the following information: a) the diameter in millimetres; b) the name or trade mark of the manufacturer; c) the number of this British Standard, i
21、.e. BS 3531-5.52). 4.2 Taps Taps shall be permanently and legibly marked with at least the following information: a) the size of screw in accordance with BS 3531-5.4 for which the tap is intended to be used; b) the name or trade mark of the manufacturer; c) the number of this British Standard, i.e.
22、BS 3531-5.52). 5 Packaging Twist drills and taps shall be packaged and labelled in accordance with BS 7254-1. Nominal screw size Twist drill diameter in accordance with BS 328 For use with self-tapping screws To prepare pilot hole for taps mm 4.0 3.5 3.0 mm 3.2 3.0 2.4 mm 3.5 3.0 2.4 (hard bone) 2.2
23、 (soft bone) 2) Marking BS 3531-5.5 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is therefore solely the responsibility of the p
24、erson making the claim. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. BS 3531-5.5:1990 2 BSI 10-1999 Figure 1 Twist drill nomenclature BS 3531-5.5:1990 BSI 10-1999 Publications referred to BS 328, Drills and reamers. BS 328-1, Spe
25、cification for twist drills. BS 328-2, Combined drills and countersinks (centre drills). BS 949, Screwing taps. BS 949-1, Specification for taps for ISO metric threads. BS 970, Specification for wrought steels for mechanical and allied engineering purposes. BS 970-1, General inspection and testing p
26、rocedures and specific requirements for carbon, carbon manganese, alloy and stainless steels. BS 3531, Implants for osteosynthesis. BS 3531-5, Bone screws and auxiliary equipment. BS 3531-5.4, Specification for screws having symmetrical thread and conical under-surfaces. BS 3531-23, Bone plates3). B
27、S 5750, Quality systems3). BS 7252, Metallic materials for surgical implants. BS 7252-5, Specification for wrought cobalt-chromium-tungsten-nickel alloy. BS 7254, Orthopaedic implants. BS 7254-1, Specification for marking, packaging and labelling. 3) Referred to in the foreword only. BS 3531-5.5: 19
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