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1、BRITISH STANDARD BS 3531-14.2: 1990 Implants for osteosynthesis Part 14: Intramedullary nailing systems Section 14.2 Specification for medullary pins (Rush type) and introducer/extractors Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 35
2、31-14.2:1990 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Board of BSI and comes into effect on 31 August 1990 BSI 10-1999 The following BSI references relate to the work on this standard: Comm
3、ittee reference HCC/22 Draft announced in BSI News October 1989 ISBN 0 580 18357 2 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 the following bod
4、ies 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 Incorporated Department of Health Institute of Sterile Services Manage
5、ment Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Coopted members Amendments issued since publication Amd. No.Date of issueComments Licensed Copy: sheffieldun sheffieldun,
6、 na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 BSI 10-1999i Contents Page Committees responsibleInside front cover Forewordii Section 1. General 1Scope1 Section 2. Medullary pins (Rush type) 2Materials1 3Method of manufacture1 4Finish1 5Dimensions and design1 6
7、Mechanical properties2 7Marking and packaging2 Section 3. Introducer/extractors for use with medullary pins 8Materials3 9Dimensions3 Figure 1 Medullary pin2 Figure 2 Introducer/extractor for use with medullary pins3 Table 1 Dimensions and range of sizes of medullary pins1 Table 2 Minimum tensile str
8、ength and minimum elongation of pins made of austenitic stainless steel2 Table 3 Dimensions of introducer/extractors for use with medullary pins3 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 35
9、31-14.2:1990 ii BSI 10-1999 Foreword This Section of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee and supersedes BS 3531-14:1984, which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants”) were first published in 1962 as
10、 BS 3531. In 1968 a 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 14:1984 giving requirem
11、ents for Rush type medullary pins and introducer/extractors. 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, t
12、he number BS 3531 is reserved for standards for implants for osteosynthesis, 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 osteo
13、synthesis and joint replacement. In the restructure, the opportunity has been taken to group together specifications for medullary nailing systems as BS 3531-14, which will be published in a number of Sections. This Section of BS 3531 introduces editorial changes to reflect this restructuring and up
14、-dates cross-references but otherwise makes no changes to the specification for medullary pins and introducer/extractors first published as BS 3531-14:1984. It does not reflect a full review or revision of the standard which will be undertaken in due course. The technical requirements of this Sectio
15、n of BS 3531 are based extensively on those of ISO 5837-2:1980 “Implants for surgery Intramedullary nailing systems Part 2: Medullary pins” prepared by Technical Committee 150, Implants for surgery, of the International Organization for Standardization (ISO) but with the following additional require
16、ments: a) a maximum value for the width of the crook end; b) mechanical properties for the pins; c) materials of construction in accordance with BS 7252; d) marking and packaging in accordance with BS 7254-1; e) restrictions on shape of point; f) dimensions for relevant introducer/extractors. Once i
17、mplantation 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 manufactured according to the recommendations given in the “Guide to Good Manufacturing Practice for Orthopaedic Implants”.1) P
18、roduct 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 suppliers quality systems against the app
19、ropriate 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 appropriate body from the list of As
20、sociation members. 1) Compiled by the Department of Health and Social Security; published and available from Her Majestys Stationary Office ISBN 0 11 320846 4. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 BSI 10-1999iii
21、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 obligations. Summary of pages This document comprises
22、a front cover, an inside front cover, pages i to iv, pages 1 to 4, 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. Licensed Copy: sheffieldun
23、sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 BSI 10-19991 Section 1. General 1 Scope This Section of BS 3531 specifies the main dim
24、ensions of, and requirements for, semi-rigid medullary pins of the type generally referred to as “Rush pins” for use in orthopaedic surgery, and for introducer/extractors for use with such medullary pins. Other types of medullary pin, e.g. flexible or Enders pins, are excluded. NOTEThe titles of the
25、 publications referred to in this standard are listed on the inside back cover. Section 2. Medullary pins (Rush type) 2 Materials Medullary pins shall be made of wrought austenitic stainless steel complying with BS 7252-1 or BS 7252-9, or of cold-worked wrought cobalt-chromium-tungsten-nickel alloy
26、complying with BS 7252-5 or of wrought titanium alloy complying with BS 7252-3. NOTEIt is frequently a contractual requirement for the supplier of the pins to produce evidence that the pins have been manufactured from material complying with the requirements of clause 2. 3 Method of manufacture The
27、pins shall be manufactured by a cold-drawing or cold-working process. Welding methods shall not be used. If local heating is used to reshape the points of pins made of stainless steel, the whole of the finished product shall be free from fissures or cracks when tested in accordance with BS 5903. Pin
28、s made of steel shall be heated at 650 C for 30 min and allowed to cool to ambient temperature prior to testing. 4 Finish The surface finish shall be in accordance with BS 7254-2. NOTEParticular care should be taken with regard to the quality of finish of the inner surface of the curved portion of t
29、he hook of the pin. 5 Dimensions and design The dimensions and design shall be in accordance with Table 1 and Figure 1. The leading end of the pin shall be either a sledge point or a domed end, and shall have no sharp edges. NOTE 1The purchaser should specify which of the two types of end (sledge po
30、int or domed) are required for the pin. NOTE 2Table 1 also gives the preferred diameters. Table 1 Dimensions and range of sizes of medullary pins Range of diameter d1a Preferred diameterb b1b2r (minimum) Range of nominal lengths lTolerance on l mmmmmmmmmmmmmm 2.25 to 2.755.0 0.5 0.5 actual diameter
31、25 to 100 in steps of 5 2.76 to 3.256.5 0.5100 to 250 in steps of 10 3.75 to 4.258.0 0.5160 to 300 in steps of 10 1.0 4.75 to 5.2510.0 0.5200 to 300 in steps of 10 6.15 to 6.5513.0 0.5280 to 420 in steps of 10 a d 1 is the diameter or largest cross-sectional dimension. b The preferred diameters are
32、in accordance with the preferred number series in BS 2045. 2.5 +0 0.1 3.0 +0 0.1 4.0 +0 0.1 3d1 +0 0.2 5.0 +0 0.1 6.3 +0 0.1 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 2 BSI 10-1999 6 Mechanical properties 6.1 Pins mad
33、e of stainless steel 6.1.1 Tensile strength. When tested in accordance with BS 4545, the tensile strength of the pin shall be as given in Table 2. Table 2 Minimum tensile strength and minimum elongation of pins made of austenitic stainless steel 6.1.2 Elongation. When tested in accordance with BS 45
34、45, the minimum elongation of the pin shall be as given in Table 2. 6.2 Pins made of wrought cobalt-chromium-tungsten-nickel alloy 6.2.1 Tensile strength. When tested in accordance with BS 18 using a gauge length of 200 2 mm, the tensile strength shall be not less than 1 280 MPa for all diameters of
35、 pin. 6.2.2 Elongation. When tested in accordance with BS 18 using a gauge length of 200 2 mm, the elongation shall be not less than 7 % for all diameters of pin. 6.3 Pins made of titanium alloy 6.3.1 Tensile strength. When tested in accordance with BS 18 using a gauge length of 200 2 mm, the tensil
36、e strength shall be within the range 1 150 MPa to 1 400 MPa for all diameters of pin. 6.3.2 Elongation. When tested in accordance with BS 18 using a gauge length of 200 2 mm, the elongation shall be not less than 3 % for all diameters of pin. 7 Marking and packaging Pins shall be marked and packaged
37、 in accordance with BS 7254-1. NOTEFor alternative ends see clause 5. Figure 1 Medullary pin Range of diameter Minimum tensile strength Minimum elongation mmMPa% 2.25 to 2.75 2.76 to 3.15 3.75 to 4.25 4.75 to 5.25 6.15 to 6.55 1 400 1 325 1 240 1 240 1 120 3 5 5 5 5 Licensed Copy: sheffieldun sheffi
38、eldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 BSI 10-19993 Section 3. Introducer/extractors for use with medullary pins 8 Materials Introducer/extractors shall be made either of wrought austenitic stainless steel complying with BS 7252-1, or of wrought c
39、obalt-chromium-tungsten-nickel alloy in accordance with BS 7252-5. 9 Dimensions The dimensions of introducer/extractors for use with medullary pins shall be as given in Figure 2 and Table 3. NOTEThe length of the slot (dimension b2, in Figure 2) is not specified in this Section of BS 3531 but the mi
40、nimum length should be such as to allow a pin of the maximum diameter with which the introducer is to be used (see dimension d1 of Table 1) to engage fully with the introducer (see dimension e in Table 3 and Figure 2). Table 3 Dimensions of introducer/extractors for use with medullary pins For use w
41、ith pins of diameter Width of slot d2 and diameter of extraction hole d3 Depth of engagement e mmmmmm 2.25 to 2.752.5 0.25 2.76 to 3.253.0 0.25 3.75 to 4.254.0 0.25 4.75 to 5.255.0 0.25 6.15 to 6.556.3 0.25 3.0 0 +0.1 3.5 0 +0.1 4.5 0 +0.1 5.5 0 +0.1 6.8 0 +0.1 NOTEThis figure depicts the designatio
42、n of dimensions and is not intended to be a representation of the design of the instrument. Figure 2 Introducer/extractor for use with medullary pins Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 blank Licensed Copy: sheffieldun sheffiel
43、dun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2:1990 BSI 10-1999 Publications referred to BS 18, Methods for tensile testing of metals (including aerospace materials). BS 2045, Preferred numbers. BS 3531, Implants for osteosynthesis2). BS 4545, Methods for mechan
44、ical testing of steel wire. BS 5750, Quality systems2). BS 5903, Method for determination of resistance to intergranular corrosion of austenitic stainless steels: copper sulphate-sulphuric acid method (Moneypenny Strauss test). BS 7251, Orthopaedic joint prostheses2). BS 7252, Metallic materials for
45、 surgical implants. BS 7252-1, Specification for wrought stainless steel. BS 7252-3, Specification for wrought titanium 6-aluminium 4-vanadium alloy. BS 7252-5, Specification for wrought cobalt-chromium-tungsten-nickel alloy. BS 7252-9, Specification for high-nitrogen stainless steel. BS 7253, Non-m
46、etallic materials for surgical implants2). BS 7254, Orthopaedic implants. BS 7254-1, Specification for marking, packaging and labelling. BS 7254-2, Specification for general requirements for materials and finish. ISO 5837, Implants for surgery Intramedullary nailing systems. ISO 5837-2, Medullary pi
47、ns2). 2) Referred to in the foreword only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:27:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-14.2: 1990 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for pre
48、paring British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editi
49、ons. 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 British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: 020 8996 9000. Fax: 020 8996 7400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards.
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