BS-3531-11-1991 ISO-8827-1988.pdf
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1、BRITISH STANDARD BS 3531-11: 1991 ISO 8827:1988 Implants for osteosynthesis Part 11: Specification for staples with parallel legs Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-11:1991 This British Standard, having been prepared und
2、er the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 29 November 1991 BSI 08-1999 First published April 1982 Second edition October 1990 Third edition November 1991 The following BSI references relate to the
3、 work on this standard: Committee reference HCC/22 Draft for comment 87/50453 DC ISBN 0 580 20265 8 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/22, upon which
4、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 Health Institute of Sterile Services Ma
5、nagement Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37
6、:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-11:1991 BSI 08-1999i Contents Page Committees responsibleInside front cover National forewordii 1Scope and field of application1 2References1 3Design1 4Size designation3 5Tolerances3 6Materials3 7Finish5 8Packaging5 9Marking of packages5 Annex A
7、 Guidance on use and selection of staples6 Figure 1 Examples of typical forms of staples for use in orthopaedic surgery2 Figure 2 Parallelism of legs4 Table Tensile properties of wire made from austenitic stainless steel4 Publication(s) referred toInside back cover Licensed Copy: sheffieldun sheffie
8、ldun, na, Wed Nov 29 03:37:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-11:1991 ii BSI 08-1999 National foreword This Part of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee and supersedes BS 3531-11:1990, which is withdrawn. It is identical with
9、ISO 8827:1988 “Implants for surgery Staples with parallel legs for orthopaedic use General requirements”, published by the International Organization for Standardization (ISO). Requirements for orthopaedic implants (then termed “surgical implants”) were first published in 1962 as BS 3531. In 1968 a
10、part revision of BS 3531:1962 was issued as BS 3531-1, which dealt with surgical implants made of all materials. In 1980 the first four Parts of a multi-part version of BS 3531 were published. A further 19 Parts of BS 3531 were subsequently published, Part 11:1982 giving requirements for orthopaedic
11、 staples. In view of the increase in the number of Parts, and with a view to facilitating the implementation of published or forthcoming international implant standards, the British Standard relating to implants has been restructured. Accordingly, the number of BS 3531 now only covers implants for o
12、steosynthesis, BS 7251 covers joint prostheses, BS 7252 covers metallic materials for surgical implants, BS 7253 covers non-metallic materials for surgical implants and BS 7254 covers orthopaedic implants, i.e. aspects common to both osteosynthesis and joint replacement. The revision of BS 3531-11 i
13、n 1990 introduced editorial changes to reflect this restructuring and to update cross-references but otherwise made no changes to the specification for staples which was first published as BS 3531-11:1982 and amended in October 1983. This revision of BS 3531-11 now covers general requirements and th
14、e designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery. 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 BS 3531 should be manufac
15、tured according to the recommendations given in the “Quality System for Orthopaedic Implants 1990 Good Manufacturing Practice”1). The Technical Committee has reviewed the provisions of ISO 5832-3 and ISO 6892 to which reference is made in the text and has decided that they are acceptable for use in
16、conjunction with this Part of BS 3531. A related British Standard to ISO 5832-3 is BS 7252-3. Cross-references International StandardCorresponding British Standard BS 7252 Metallic materials for surgical implants ISO 5832-1:1987Part 1:1990 Specification for wrought stainless steel (Identical) ISO 58
17、32-4:1978Part 4:1990 Specification for cobalt-chromium-molybdenum casting alloy (Identical) IEC 5832-5:1978Part 5:1990 Specification for wrought cobalt-chrominium-tungsten-nickel alloy (Identical) ISO 6018:1987BS 7254 Orthopaedic implants Part 1:1990 Specification for marking, packaging and labellin
18、g (Identical) 1) Compiled by the Department of Health; published and available from HMSO, 49 High Holborn, London WC1 6HB for personal callers, or by post from HMSO, P O Box 276, London SW8 5DT. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:11 GMT+00:00 2006, Uncontrolled Copy, (c) BS
19、I BS 3531-11:1991 BSI 08-1999iii 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 surveillance, which may be coupled with assessment of a supplie
20、rs 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 consider approaching an ap
21、propriate 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 from legal o
22、bligations. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 6, 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 amendment table o
23、n the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-11:1991 BSI 08-19991 1 Scope and field of a
24、pplication This International Standard covers general requirements and the designation of dimensions and tolerances of staples with parallel legs intended for use in orthopaedic surgery. NOTEThe Annex gives guidance on the selection and use of staples and does not form an integral part of this Inter
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