1、BRITISH STANDARD BS3531-6.2: 1991 ISO5838-2: 1991 Implants for osteosynthesis Part6: Skeletal pins and wires Section6.2 Specification for dimensions of Steinmann skeletal pinsBS3531-6.2:1991 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee,
2、 waspublished under the authorityof the Standards Boardand comes into effect on 30 September1991 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft announced in BSI News March1989 ISBN 0 580 19937 1 Committees responsible for this British S
3、tandard 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: British Institute of Surgical Technologists British Investment Casting Trade Association British Medica
4、l Association British Orthopaedic Association British Steel Industry British Surgical Trades Association 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
5、Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-6.2:1991 BSI 09-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope 1 2 Dimensions 1 3 Ends 2 4 Marking of packages 2 Figure 1 Main dimensions of skeletal
6、 pins 1 Figure 2 Recommended point of Steinmann skeletal pin 2 Figure 3 Form A: Circular end 2 Figure 4 Form B: Square end 2 Figure 5 Triangular end 2 Table 1 Main dimensions of skeletal pins 1 Table 2 Dimensions of form B end 2 Table 3 Dimensions of form C end 2 Publication(s) referred to Inside ba
7、ck coverBS3531-6.2:1991 ii BSI 09-1999 National foreword This Section of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee and is identical with ISO5838-2:1991 “Implants for surgery Skeletal pins and wires Part 2: Steinmann skeletal pins Dimensions”, publishe
8、d by the International Organization for Standardization(ISO). Requirements for orthopaedic implants(then termed “surgical implants”) were first published in1962 as BS3531. In1986 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with surgical implants made of all materials. In1980 t
9、he first four Parts of a multi-part version of BS3531 were published. A further19 Parts of BS3531 were subsequently published, BS3531-6:1982, which is now withdrawn, giving requirements for skeletal pins and wires. In view of the increase in the number of Parts, and with a view to facilitating the i
10、mplementation of published or forthcoming ISO implants standards, the British Standard relating to implants has been restructured. BS3531 now only covers implants for osteosynthesis, BS7251 covers joint prostheses, BS7252 covers metallic materials for surgical implants, BS7253 covers non-metallic ma
11、terials for surgical implants and BS7254 covers orthopaedic implants, i.e.aspects common to both osteosynthesis and joint replacement. General 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 should
12、 be manufactured according to the recommendations given in the “Quality Systems for Orthopaedic Implants1990 Good Manufacturing Practice”. 1) Cross-references. The Technical Committee has reviewed the provisions of ISO5838-1:1983, to which reference is made in the text, and has decided that they are
13、 acceptable for use in conjunction with this standard. A related British Standard to ISO5838-1:1983 is BS3531-6.1:1990 in that as well as specifying general material and mechanical requirements, additional provision is made for the skeletal pins, skeletal wires, guide wires, fixation and threaded pi
14、ns and wires. Textual error. When adopting the text of the International Standard the following error was discovered. The4mm diameter features in Table 2 and Table 3 but has been omitted from Table 1. Although this standard requires only the length, diameter and end shape of the skeletal pin to be m
15、arked on the packaging, attention is drawn to BS7254-1 which gives requirements for marking, packaging and labelling of orthopaedic implants. Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this Br
16、itish Standard based on testing and continued 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 will be forwarded by BSI to the Association of Certification B
17、odies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. 1) Compiled by the Department of Health; published and available from Her Majestys Stationery Office,49 High Holborn, London WC16HB, for pe
18、rsonal callers, or by post from HMSO, PO Box276, London SW85DT.BS3531-6.2:1991 BSI 09-1999 iii 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
19、not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi toiv, 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 wil
20、l be indicated in the amendment table on the inside front cover.iv blankBS3531-6.2:1991 BSI 09-1999 1 1 Scope This part of ISO5838 specifies the dimensions of Steinmann skeletal pins. Material and mechanical requirements are covered by ISO5838-1. NOTE 1Attention is drawn to the possible need for dif
21、ferent designs of points depending on such factors as the method of insertion, and the site of insertion, i.e.whether the bone is cancellous or cortical. 2 Dimensions Dimensions shall be in accordance with Figure 1 to Figure 5 and Table 1 to Table 3. All dimensions in this part of ISO5838 are given
22、in millimetres. Table 1 Main dimensions of skeletal pins Diameter d Length l 2 3,5 4,5 125to300 5 0 0,048 Figure 1 Main dimensions of skeletal pinsBS3531-6.2:1991 2 BSI 09-1999 3 Ends 3.1 General One end of the pin shall be formed into a point. The end opposite the point shall comply with one of the
23、 forms A, B or C as given in3.2, 3.3 and3.4. NOTE 2It is recommended that the pointed end is as shown in Figure 2. 3.2 Form A Plain 3.3 Form B Square Table 2 Dimensions of form B end 3.4 Form C Triangular Table 3 Dimensions of form C end 4 Marking of packages The length and diameter of Steinmann ske
24、letal pins and the shape of the end(i.e.circular, square, triangular) shall be stated on the packaging. Figure 2 Recommended point of Steinmann skeletal pin Figure 3 Form A: Circular end Figure 4 Form B: Square end Diameter d s 3,5 2,7 4 3,15 4,5 3,55 5 4 Figure 5 Triangular end Diameter d h 3,5 3,2
25、 4 3,7 4,5 4,2 5 4,7 0 0,048 0 001 , 0 0,048 0 001 , BS3531-6.2:1991 BSI 09-1999 Publication(s) referred to Seenational foreword.BS3531-6.2: 1991 ISO5838-2: 1991 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing Bri
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