BS 3531-5 5-1990 Implants for osteosynthesis - Bone screws and auxiliary equipment - Specification for taps and drills《骨接合术外科植入物 骨螺钉和辅助装置 丝锥和钻头规范》.pdf

1、BRITISH STANDARD BS3531-5.5: 1990 Implants for osteosynthesis Part5: Bone screws and auxiliary equipment Section5.5 Specification for taps and drillsBS3531-5.5:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the au

2、thorityof the Board of BSI andcomes into effect on 30April1990 BSI10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment87/54793 ISBN0 580 17918 4 Committees responsible for this British Standard The preparation of this British Standard

3、 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 Association B

4、ritish 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 Scottish

5、Office Coopted members Amendments issued since publication Amd. No. Date of issue CommentsBS3531-5.5:1990 BSI 10-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Twist drills 1 3 Taps 1 4 Marking 1 5 Packaging 1 Figure 1 Twist drill nomenclature 2 Table 1 Recomm

6、ended sizes of twist drills 1 Publications referred to Inside front coverBS3531-5.5:1990 ii BSI 10-1999 Foreword This Section of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee. It partially supersedes BS3531-5:1982 and comprises similar requirements for th

7、e taps and drills that were previously specified in BS3531-5:1982, which also contained requirements for particular types of bone screw, for screwdrivers and for holes and slots in bone plates. The revision of BS3531-5 offered the opportunity to facilitate the implementation of published and forthco

8、ming International Standards, and to separate, in different Parts of BS3531, requirements for screws and auxiliary equipment from those for bone plates. Accordingly therefore, requirements for bone screws and auxiliary equipment are retained in BS3531-5, which is to be published in separate Sections

9、, whilst requirements for bone plates are specified in BS3531-23, also to be published in Sections. BS3531-5:1982 is withdrawn. The taps and drills specified in this Section of BS3531 are suitable for use with the screws specified in BS3531-5.4, and the requirements differ from those in BS3531-5:198

10、2 only by permitting the use of two grades of stainless steel in place of the single grade in Part5 which is now unobtainable. It is strongly recommended that the products specified in this Section of BS3531 should be manufactured according to the recommendations given in the “Guide to Good Manufact

11、uring 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 BritishStandard based on testing and continuing surveillance, which may be coupled with assessment

12、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 not already exist, users should consider approa

13、ching 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 confer immunity f

14、rom legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 and2, 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 indicated in the amendmen

15、t table on the inside front cover. 1) Compiled by the Department of Health and Social Security; published and available from Her Majestys Stationery Office. ISBN0 11 320846 4.BS3531-5.5:1990 BSI 10-1999 1 1 Scope This Section of BS3531 specifies general requirements for twist drills and taps for use

16、 with bone screws specified in BS3531-5.4. 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 grades420S37 or302S31 in accordance with BS970-1, or of cold worked wrought cobalt-chromium-

17、tungsten-nickel alloy in accordance with BS7252-5. 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 be130 C. Experimental evidence has indicated that optimum results may be obtained with human bone by using a d

18、rill 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 stainless steel of grades420S37

19、or302S31 in accordance with BS970-1, or of cold worked wrought cobalt-chromium-tungsten-nickel alloy in accordance with BS7252-5. 3.2 Design The thread form of taps shall correspond with the thread form of the appropriate screw specified in BS3531-5.4. NOTESeeBS949-1 for nomenclature and designation

20、 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.e.BS3531-5.5 2) . 4.2 Taps Taps sh

21、all be permanently and legibly marked with at least the following information: a) the size of screw in accordance with BS3531-5.4 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.BS3531-5.5 2) . 5 Packaging Twist dri

22、lls and taps shall be packaged and labelled in accordance with BS7254-1. Nominal screw size Twist drill diameter in accordance with BS328 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 (soft bone) 2) Marking BS3531-5.5 on

23、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 person making the claim. Such a declarati

24、on is not to be confused with third party certification of conformity, which may also be desirable.BS3531-5.5:1990 2 BSI 10-1999 Figure 1 Twist drill nomenclatureBS3531-5.5:1990 BSI 10-1999 Publications referred to BS328, Drills and reamers. BS328-1, Specification for twist drills. BS328-2, Combined

25、 drills and countersinks (centre drills). BS949, Screwing taps. BS949-1, Specification for taps for ISO metric threads. BS970, Specification for wrought steels for mechanical and allied engineering purposes. BS970-1, General inspection and testing procedures and specific requirements for carbon, car

26、bon manganese, alloy and stainless steels. BS3531, Implants for osteosynthesis. BS3531-5, Bone screws and auxiliary equipment. BS3531-5.4, Specification for screws having symmetrical thread and conical under-surfaces. BS3531-23, Bone plates 3) . BS5750, Quality systems 3) . BS7252, Metallic material

27、s for surgical implants. BS7252-5, Specification for wrought cobalt-chromium-tungsten-nickel alloy. BS7254, Orthopaedic implants. BS7254-1, Specification for marking, packaging and labelling. 3) Referred to in the foreword only.BS3531-5.5: 1990 BSI 389 Chiswick High Road London W4 4AL BSIBritishStan

28、dardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendment or revision. Users of BritishStand

29、ards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this BritishStandard would inform the Secretary of the technical

30、 committee responsible, the identity of which can be found on the inside front cover. Tel:02089969000. Fax:02089967400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all

31、 BSI, international and foreign standards publications should be addressed to Customer Services. Tel:02089969001. Fax:02089967001. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as BritishStandards, unless otherw

32、ise requested. Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information services are also available which give details on all its products an

33、d services. Contact the Information Centre. Tel:02089967111. Fax:02089967048. Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For details of these and other benefits contact Membership Administration. Te

34、l:02089967002. Fax:02089967001. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publications of the international standardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored i

35、n a retrieval system or transmitted in any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade d

36、esignations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tel:02089967070.