1、BRITISH STANDARD BS3531-14.2: 1990 Implants for osteosynthesis Part14: Intramedullary nailing systems Section14.2 Specification for medullary pins (Rush type) and introducer/extractorsBS3531-14.2:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy
2、Committee, waspublished under the authorityof the Board of BSI andcomes into effect on 31August1990 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft announced in BSI News October1989 ISBN 0 580 18357 2 Committees responsible for this Brit
3、ish 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: British Institute of Surgical Technologists British Investment Casting Trade Association British
4、Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Incorporated Department of Health Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of S
5、urgeons of England Royal Veterinary College Scottish Office Coopted members Amendments issued since publication Amd. No. Date of issue CommentsBS3531-14.2:1990 BSI 10-1999 i Contents Page Committees responsible Inside front cover Foreword ii Section 1. General 1 Scope 1 Section 2. Medullary pins (Ru
6、sh type) 2 Materials 1 3 Method of manufacture 1 4 Finish 1 5 Dimensions and design 1 6 Mechanical properties 2 7 Marking and packaging 2 Section 3. Introducer/extractors for use with medullary pins 8 Materials 3 9 Dimensions 3 Figure 1 Medullary pin 2 Figure 2 Introducer/extractor for use with medu
7、llary pins 3 Table 1 Dimensions and range of sizes of medullary pins 1 Table 2 Minimum tensile strength and minimum elongation of pins made of austenitic stainless steel 2 Table 3 Dimensions of introducer/extractors for use with medullary pins 3 Publications referred to Inside back coverBS3531-14.2:
8、1990 ii BSI 10-1999 Foreword This Section of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee and supersedes BS3531-14:1984, which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants”) were first published in1962 as BS3531. In
9、1968 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 of BS3531 were subsequently published, Part14:1984 giving requirements for Rush type m
10、edullary 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, the number BS3531 is
11、reserved for standards for implants for osteosynthesis, BS7251 covers joint prostheses, BS7252 covers metallic materials for surgical implants, BS7253 covers non-metallic materials for surgical implants and BS7254 covers orthopaedic implants i.e.aspects common to both osteosynthesis and joint replac
12、ement. In the restructure, the opportunity has been taken to group together specifications for medullary nailing systems as BS3531-14, which will be published in a number of Sections. This Section of BS3531 introduces editorial changes to reflect this restructuring and up-dates cross-references but
13、otherwise makes no changes to the specification for medullary pins and introducer/extractors first published as BS3531-14:1984. It does not reflect a full review or revision of the standard which will be undertaken in due course. The technical requirements of this Section of BS3531 are based extensi
14、vely on those of ISO5837-2:1980 “Implants for surgery Intramedullary nailing systems Part2: Medullary pins” prepared by Technical Committee150, Implants for surgery, of the International Organization for Standardization (ISO) but with the following additional requirements: a) a maximum value for the
15、 width of the crook end; b) mechanical properties for the pins; c) materials of construction in accordance with BS7252; d) marking and packaging in accordance with BS7254-1; e) restrictions on shape of point; f) dimensions for relevant introducer/extractors. Once implantation has been completed, an
16、implant should never be reused after removal. It is strongly recommended that the products specified in this Section of BS3531 should be manufactured according to the recommendations given in the “Guide to Good Manufacturing Practice for Orthopaedic Implants”. 1) Product certification. Users of this
17、 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 appropriate Part of BS5750. Enquiries
18、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 Association members. 1) Compiled by th
19、e Department of Health and Social Security; published and available from Her Majestys Stationary Office ISBN0 11 320846 4.BS3531-14.2:1990 BSI 10-1999 iii A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their c
20、orrect 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, pagesi toiv, pages1 to4, an inside back cover and a back cover. This standard has been updated (see copyrig
21、ht date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS3531-14.2:1990 BSI 10-1999 1 Section 1. General 1 Scope This Section of BS3531 specifies the main dimensions of, and requirements for, semi-rigid medullary pins of the
22、 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 publications referred to in this standard are listed on the inside
23、 back cover. Section 2. Medullary pins (Rush type) 2 Materials Medullary pins shall be made of wrought austenitic stainless steel complying with BS7252-1 or BS7252-9, or of cold-worked wrought cobalt-chromium-tungsten-nickel alloy complying with BS7252-5 or of wrought titanium alloy complying with B
24、S7252-3. 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 clause2. 3 Method of manufacture The pins shall be manufactured by a cold-drawing or cold-working process. We
25、lding 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 BS5903. Pins made of steel shall be heated at650 C for30min and allowed to cool to a
26、mbient temperature prior to testing. 4 Finish The surface finish shall be in accordance with BS7254-2. NOTEParticular care should be taken with regard to the quality of finish of the inner surface of the curved portion of the hook of the pin. 5 Dimensions and design The dimensions and design shall b
27、e 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 point or domed) are required for the pin. NOTE 2Table 1 also gives the preferre
28、d diameters. Table 1 Dimensions and range of sizes of medullary pins Range of diameter d 1 a Preferred diameter b b 1 b 2 r (minimum) Range of nominal lengths l Tolerance onl mm mm mm mm mm mm mm 2.25 to2.75 5.0 0.5 0.5 actual diameter 25 to100 in steps of 5 2.76 to3.25 6.5 0.5 100 to250 in steps of
29、10 3.75 to4.25 8.0 0.5 160 to300 in steps of10 1.0 4.75 to5.25 10.0 0.5 200 to300 in steps of10 6.15 to6.55 13.0 0.5 280 to420 in steps of10 a d 1is the diameter or largest cross-sectional dimension. b The preferred diameters are in accordance with the preferred number series in BS2045. 2.5 +0 0.1 3
30、.0 +0 0.1 4.0 +0 0.1 3 d 1 +0 0.2 5.0 +0 0.1 6.3 +0 0.1BS3531-14.2:1990 2 BSI 10-1999 6 Mechanical properties 6.1 Pins made of stainless steel 6.1.1 Tensile strength. When tested in accordance with BS4545, the tensile strength of the pin shall be as given in Table 2. Table 2 Minimum tensile strength
31、 and minimum elongation of pins made of austenitic stainless steel 6.1.2 Elongation. When tested in accordance with BS4545, 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
32、 with BS18 using a gauge length of2002mm, the tensile strength shall be not less than1280MPa for all diameters of pin. 6.2.2 Elongation. When tested in accordance with BS18 using a gauge length of2002mm, the elongation shall be not less than7% for all diameters of pin. 6.3 Pins made of titanium allo
33、y 6.3.1 Tensile strength. When tested in accordance with BS18 using a gauge length of2002mm, the tensile strength shall be within the range1150MPa to1400MPa for all diameters of pin. 6.3.2 Elongation. When tested in accordance with BS18 using a gauge length of2002mm, the elongation shall be not less
34、 than3% for all diameters of pin. 7 Marking and packaging Pins shall be marked and packaged in accordance with BS7254-1. NOTEFor alternative ends seeclause5. Figure 1 Medullary pin Range of diameter Minimum tensile strength Minimum elongation mm MPa % 2.25 to2.75 2.76 to3.15 3.75 to4.25 4.75 to5.25
35、6.15 to6.55 1400 1325 1240 1240 1120 3 5 5 5 5BS3531-14.2:1990 BSI 10-1999 3 Section 3. Introducer/extractors for use with medullary pins 8 Materials Introducer/extractors shall be made either of wrought austenitic stainless steel complying with BS7252-1, or of wrought cobalt-chromium-tungsten-nicke
36、l alloy in accordance with BS7252-5. 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 b 2 , in Figure 2) is not specified in this Section of BS3531 but the minimum length should be such a
37、s to allow a pin of the maximum diameter with which the introducer is to be used (seedimension d 1of Table 1) to engage fully with the introducer (seedimension e in Table 3 and Figure 2). Table 3 Dimensions of introducer/extractors for use with medullary pins For use with pins of diameter Width of s
38、lot d 2and diameter of extraction hole d 3 Depth of engagement e mm mm mm 2.25 to2.75 2.5 0.25 2.76 to3.25 3.0 0.25 3.75 to4.25 4.0 0.25 4.75 to5.25 5.0 0.25 6.15 to6.55 6.3 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 designation of dimensions and is not i
39、ntended to be a representation of the design of the instrument. Figure 2 Introducer/extractor for use with medullary pins4 blankBS3531-14.2:1990 BSI 10-1999 Publications referred to BS18, Methods for tensile testing of metals (including aerospace materials). BS2045, Preferred numbers. BS3531, Implan
40、ts for osteosynthesis 2) . BS4545, Methods for mechanical testing of steel wire. BS5750, Quality systems 2) . BS5903, Method for determination of resistance to intergranular corrosion of austenitic stainless steels: copper sulphate-sulphuric acid method (Moneypenny Strauss test). BS7251, Orthopaedic
41、 joint prostheses 2) . BS7252, Metallic materials for surgical implants. BS7252-1, Specification for wrought stainless steel. BS7252-3, Specification for wrought titanium6-aluminium4-vanadium alloy. BS7252-5, Specification for wrought cobalt-chromium-tungsten-nickel alloy. BS7252-9, Specification fo
42、r high-nitrogen stainless steel. BS7253, Non-metallic materials for surgical implants 2) . BS7254, Orthopaedic implants. BS7254-1, Specification for marking, packaging and labelling. BS7254-2, Specification for general requirements for materials and finish. ISO5837, Implants for surgery Intramedulla
43、ry nailing systems. ISO5837-2, Medullary pins 2) . 2) Referred to in the foreword only.BS3531-14.2: 1990 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view on standards in Eu
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