BS-3531-5.6-1991 ISO-6475-1989.pdf
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1、BRITISH STANDARD BS 3531-5.6: 1991 ISO 6475:1989 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.6 Specification for the mechanical requirements and test methods for screws having asymmetrical thread and spherical undersurface Licensed Copy: sheffieldun sheffieldun,
2、 na, Wed Nov 29 03:37:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.6:1991 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 30 August 1991 BSI 09-
3、1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment 86/55442 DC ISBN 0 580 19966 5 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee to
4、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 British Steel Industry British Surgical Trades Association Department of
5、Health Institute of Sterile Services Management Medical Sterile Products Association National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office The following body was also represented in the drafting of the standard, through subcommittees and
6、 panels: Department of Trade and Industry (National Engineering Laboratory) Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.6:1991 BSI 09-1999i Contents Page Committees respo
7、nsibleInside front cover National forewordii Introduction1 1Scope1 2Normative references1 3Test method1 4Test report1 Annex A (normative) Mechanical requirements for stainless steel bone screws2 Annex B (informative) Interrelationship of International Standards dealing with bone screws, bone plates
8、and relevant tools3 Annex C (informative) Bibliography: International Standards referred to in table of Annex B4 Table A.1 Minimum breaking torque and minimum angle of rotation at failure2 Publication(s) referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:09 GMT
9、+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.6:1991 ii BSI 09-1999 National foreword This Section of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO 6475 “Implants for surgery Metal bone screws with asymmetrical thread and sp
10、herical under-surface Mechanical requirements and test methods”, published by the International Organization for Standardization (ISO). BS 3531-5 was first published in 1982 and gave requirements for particular types of bone screw, for taps, drills and screwdrivers, and for holes and slots in bone p
11、lates. The revision of BS 3531-5 offered the opportunity to facilitate the implementation of published and forthcoming International Standards, and to separate, in different Parts of BS 3531, requirements for screws and auxiliary equipment from those for bone plates. Requirements for bone screws and
12、 their auxiliary equipment are retained in BS 3531-5, which is now published in a number of Sections, whilst requirements for bone plates are specified in BS 3531-23, also published in Sections. BS 3531-5:1982 is withdrawn. This standard is for use with screws specified in BS 3531-5.3. It is strongl
13、y recommended that the products specified in this Section of BS 3531 should be manufactured according to the recommendations given in the “Quality Systems for Orthopaedic Implants 1990 Good Manufacturing Practice”1). Product certification. Users of this British Standard are advised to consider the d
14、esirability of third party certification of product conformity with this British Standard based on testing and continued surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS 5750. Enquiries as to the availability of third party certific
15、ation will be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does 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 provis
16、ions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, and inside front cover, pages i and ii, pages 1 to 4, an
17、 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 amendment table on the inside front cover. Cross-references International StandardCorresponding British Standard ISO 5832-1:1987BS 7252 Met
18、allic materials for surgical implants Part 1:1990 Specification for wrought stainless steel (Identical) ISO 5835:1991BS 3531 Implants for osteosynthesis Section 5.3:1991 Specification for dimensions of screws having hexagonal drive connection spherical under-surfaces and asymmetrical thread (Identic
19、al) 1) Compiled by the Department of Health; published and available from Her Majestys Stationery Office, 49 High Holborn, London WC1 6HB for personal callers or by post from HMSO, PO Box 276, London SW8 5DT. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:09 GMT+00:00 2006, Uncontrolle
20、d Copy, (c) BSI BS 3531-5.6:1991 BSI 09-19991 Introduction This International Standard does not purport to address all of the safety problems associated with its use. It is the responsibility of whoever uses it to consult and establish appropriate safety and health practices and determine the applic
21、ability of regulatory limitations prior to use. The results obtained in this method bear no direct correlation to the use of the subject bone screw. This test method is used only for purposes of maintaining the uniformity of the product tested. 1 Scope This International Standard specifies the test
22、methods for determining breaking torque and angle of rotation at failure for metal bone screws for surgery. Mechanical requirements for bone screws are specified in Annex A. NOTE 1At present data are only available for bone screws with dimensions according to ISO 5835 and made from stainless steel a
23、ccording to ISO 5832-1. If data become available for bone screws made from other materials and/or with other standardized dimensions, they will be added in further annexes. NOTE 2The interrelationship of International Standards dealing with bone plates, bone screws and relevant tools is shown for in
24、formation in Annex B. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to ag
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