1、BRITISH STANDARD BS3531-6.3: 1994 ISO5838-3: 1993 Implants for osteosynthesis Part6: Skeletal pins and wires Section 6.3 Specification for Kirschner skeletal wires UDC 616.71-089.843-74:615.465BS3531-6.3:1994 This British Standard, having been prepared under the directionof the Health Care Standards
2、 Policy Committee, waspublished under the authorityof the Standards Boardand comes intoeffecton 15January1994 BSI 08-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment92/52887 DC ISBN 0 580 22784 7 Committees responsible for this Briti
3、sh Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/22, upon which the following bodies were represented: Association of British Health-care Industries British Institute of Surgical Technologists British
4、Investment Casting Trade Association British Medical Association British Steel Industry British Surgical Trades Association Department of Health Institute of Sterile Services Management Medical Sterile Products Association National Association of Theatre Nurses Royal College of Surgeons of England R
5、oyal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-6.3:1994 BSI 08-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope 1 2 Normative references 1 3 Dimensions 1 4 Ends 1 5 Marking and packaging 1 Annex A (i
6、nformative) Points and blunt ends 2 Figure 1 Main dimensions of Kirschner wires 1 Figure 2 Form A: trocar point 1 Figure A.1 Points and blunt ends 2 Table 1 Main dimensions of Kirschner wires 1 List of references Inside back coverBS3531-6.3:1994 ii BSI 08-1999 National foreword This Section of BS353
7、1 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO5838-3:1993 Implants for surgery Skeletal pins and wires Part3: Kirschner skeletal wires, published by the International Organization for Standardization (ISO). Requirements for orthopaedic
8、 implants (then termed “surgical implants”) were first published in1962 as BS3531. In1968 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with surgical implants made of all materials. In1980 the first four Parts of a multi-Part version of BS3531 were published. A further19 Parts o
9、f BS3531 were subsequently published, Part6:1982, which is now withdrawn, giving requirements for skeletal pins and wires. As a result of the development of so many disparate Parts of BS3531 and because of the anticipated need to implement a number of published and forthcoming ISO standards that wou
10、ld have increased the diversity of BS3531 still further, it was decided that BS3531 should be restructured as five distinct standards which would enable the various aspects to be clearly differentiated. BS3531 itself was limited to standards specific to implants for osteosynthesis and its title chan
11、ged accordingly. Four new standards were published, incorporating Parts of BS3531 as well as new ISO standards. These are: BS7251, Orthopaedic joint prostheses. BS7252, Metallic materials for surgical implants. BS7253, Non-metallic materials for surgical implants. BS7254, Orthopaedic implants. Gener
12、al requirements for skeletal pins and wires are published as BS3531-6.1. It is strongly recommended that the products specified in this Section of BS3531-6 should be manufactured according to the recommendations given in Quality Systems for Orthopaedic Implants1990 Good Manufacturing Practice 1) . T
13、he Technical Committee has reviewed the provisions of ISO5838-1:1983, to which normative reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. A related British Standard to ISO5838-1:1983 is BS3531-6.1:1990 which, as well as specifying gen
14、eral material and mechanical requirements, makes additional provision for skeletal pins, skeletal wires, guide wires, fixation and thread pins and wires. Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity
15、with this British Standard based on testing and continuing surveillance 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 are forwarded by BSI to the Association of Certifi
16、cation Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. Cross-references International Standard Corresponding British Standard ISO6018:1987 BS7254 Orthopaedic implants Part1:1990 Specific
17、ation for marking, packaging and labelling (Identical) 1) Compiled by the Department of Health; published and available from HMSO,49 High Holborn, London WC1 for personal callers, or by post from HMSO, PO Box276, London SW85DT.BS3531-6.3:1994 BSI 08-1999 iii A British Standard does not purport to in
18、clude 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 obligations. Summary of pages This document comprises a front cover, an inside front cover, pag
19、esi toiv, pages1 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 indicated in the amendment table on the inside front cover.iv blankBS3531-6.3:1994 BSI 08-1999 1 1 Scope This part of ISO5838 spec
20、ifies the characteristics of skeletal wires of the Kirschner type. Material and mechanical requirements are covered by ISO5838-1. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO5838. At the time of pub
21、lication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO5838 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers o
22、f currently valid International Standards. ISO5838-1:1983, Implants for surgery Skeletal pins and wires Part1: Material and mechanical requirements. ISO6018:1987, Orthopaedic implants General requirements for marking, packaging and labelling. 3 Dimensions The dimensions shall be in accordance with F
23、igure 1 and Figure 2, and Table 1. 4 Ends One or both ends of the wire shall be formed into a point. If the point is a trocar point, then the angles of the flats forming the point shall be as shown in Figure 2. NOTE 1Annex A illustrates different points and blunt ends which may be used. 5 Marking an
24、d packaging Skeletal wires of the Kirschner type shall be packaged and marked as specified in ISO6018. The packaging shall show the length and diameter of the wires, expressed in millimetres, and indicate the type of the ends. Table 1 Main dimensions of Kirschner wires Dimensions in millimetres Diam
25、eter Length L 2 0,8u d u 1,3 70u L u 310 1,4u d u 2,5 150 u L u 310 d=3,0 150 u L u 310 d 0 0,04 Figure 1 Main dimensions of Kirschner wires Figure 2 Form A: trocar pointBS3531-6.3:1994 2 BSI 08-1999 Annex A (informative) Points and blunt ends NOTE 2Wires may be smooth shank or threaded. NOTE 3Point
26、 angle and helix angle, where applicable, is as specified by the manufacturer. NOTE 4Optional designs: both ends pointed or point with suture hole are also possible. Figure A.1 Points and blunt endsBS3531-6.3:1994 BSI 08-1999 List of references See national foreword.BS3531-6.3: 1994 ISO5838-3: 1993
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