1、BRITISH STANDARD BS3531-11: 1991 ISO8827:1988 Implants for osteosynthesis Part11: Specification for staples with parallel legsBS3531-11:1991 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Standards
2、Boardand comes into effect on 29November 1991 BSI08-1999 First published April1982 Second edition October1990 Third edition November1991 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment87/50453DC ISBN 0 580 20265 8 Committees responsible
3、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 bodies were represented: British Institute of Surgical Technologists British Investment Casting Trade Associa
4、tion British Medical 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 S
5、urgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-11:1991 BSI 08-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope and field of application 1 2 References 1 3 Design 1 4 Size designat
6、ion 3 5 Tolerances 3 6 Materials 3 7 Finish 5 8 Packaging 5 9 Marking of packages 5 Annex A Guidance on use and selection of staples 6 Figure 1 Examples of typical forms of staples for use in orthopaedic surgery 2 Figure 2 Parallelism of legs 4 Table Tensile properties of wire made from austenitic s
7、tainless steel 4 Publication(s) referred to Inside back coverBS3531-11:1991 ii BSI 08-1999 National foreword This Part of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee and supersedes BS3531-11:1990, which is withdrawn. It is identical with ISO8827:1988 “I
8、mplants 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 in1962 as BS3531. In1968 a part revision of BS
9、3531:1962 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, Part11:1982 giving requirements for orthopaedic staples. In view of the i
10、ncrease 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 BS3531 now only covers implants for osteosynthesis, BS7251 cover
11、s 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 replacement. The revision of BS3531-11 in1990 introduced editorial change
12、s to reflect this restructuring and to update cross-references but otherwise made no changes to the specification for staples which was first published as BS3531-11:1982 and amended in October 1983. This revision of BS3531-11 now covers general requirements and the designation of dimensions and tole
13、rances 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 BS3531 should be manufactured according to the recommendation
14、s given in the “Quality System for Orthopaedic Implants1990 Good Manufacturing Practice” 1) . The Technical Committee has reviewed the provisions of ISO5832-3 and ISO6892 to which reference is made in the text and has decided that they are acceptable for use in conjunction with this Part of BS3531.
15、A related BritishStandard to ISO5832-3 is BS7252-3. Cross-references International Standard Corresponding British Standard BS7252 Metallic materials for surgical implants ISO5832-1:1987 Part1:1990 Specification for wrought stainless steel (Identical) ISO5832-4:1978 Part4:1990 Specification for cobal
16、t-chromium-molybdenum casting alloy (Identical) IEC5832-5:1978 Part5:1990 Specification for wrought cobalt-chrominium-tungsten-nickel alloy (Identical) ISO6018:1987 BS7254 Orthopaedic implants Part1:1990 Specification for marking, packaging and labelling (Identical) 1) Compiled by the Department of
17、Health; published and available from HMSO,49 High Holborn, London WC16HB for personal callers, or by post from HMSO, P O Box276, London SW85DT.BS3531-11:1991 BSI 08-1999 iii Product certification. Users of this British Standard are advised to consider the desirability of third party certification of
18、 product conformity with this BritishStandard 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
19、 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. A British Standard does not purport to include all the necessary provisions of a contract. Users of British
20、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, pagesi toiv, pages1to6, an inside back cover and a back cover. This st
21、andard 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 blankBS3531-11:1991 BSI 08-1999 1 1 Scope and field of application This International Standard covers general requirements and the designa
22、tion 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 International Standard. 2 References ISO5832, Implants for surgery Metallic materials P
23、art1: Wrought stainless steel Part3: Wrought titanium 6-aluminium4-vanadium alloy Part4: Cobalt-chromium-molybdenum casting alloy Part5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO6018, Implants for surgery General requirements for marking, packaging and labelling. ISO6892, Metallic materials
24、 Tensile testing. 3 Design 3.1 Radius of curvature The internal radius of curvature of staples made from wire shall be not less than2mm or the diameter of the wire, whichever is the greater. Thecurve shall have a smooth contour. 3.2 Points Points of staples shall be conical, trocar-shaped, spear-sha
25、ped or flattened (i.etapered in one plane). 3.3 Legs The legs shall be parallel. NOTE 1Examples of typical forms of staples used in orthopaedic surgery are illustrated in Figure 1. Figure 1 shows the designation of dimensions and gives nomenclature; it does not purport to specify design requirements
26、 and does not otherwise form part of the requirements for staples as laid down in this International Standard. NOTE 2Staples are commonly of circular, oval or modified rectangular cross-section, although other forms may be used. If staples are made from wire, wire2,5mm in diameter is commonly used.
27、Greater strength may be achieved by using an oval cross-section, generally of the order of4mm 2mm, or by reinforcing the bend area with webs see Figure 1b). The legs may be plain, or have barbs or other surface features or treatments.BS3531-11:1991 2 BSI 08-1999 Figure 1 Examples of typical forms of
28、 staples for use in orthopaedic surgeryBS3531-11:1991 BSI 08-1999 3 4 Size designation The size of staples shall be designated by effective length, l, effective width, b, and diameter, d, respectively (see Figure 1), expressed in millimetres, as follows: 25 20 1 Staples with legs of unequal length s
29、hall have the effective length of each leg stated. Staples of oval or modified rectangular cross-section shall have the major and minor cross-sectional dimensions stated. 5 Tolerances The effective length and effective width of staples shall be in accordance with the nominal dimensions 1mm. The axis
30、 of one leg of the staple shall be parallel, with respect to the axis of the other leg, within a cylindrical tolerance zone0,5mm in diameter (seeFigure 2). In the case of table staples see Figure 1i), the parallelism tolerances shall apply to each and every pair of legs. 6 Materials 6.1 General Stap
31、les shall be made from austenitic stainless steel, cast cobalt-chromium-molybdenum alloy, wrought cobalt-chromium-tungsten-nickel alloy, or wrought titanium alloy. When produced from wire or by casting, the material shall satisfy the requirements laid down in6.2, 6.3, 6.4 and6.5. NOTEThe figures ill
32、ustrate various types of staple for the purpose of defining the relevant dimensions and features, but the illustrations do not otherwise form part of the requirements for staples as laid down in this International Standard. Figure 1 Examples of typical forms of staples for use in orthopaedic surgery
33、 (concluded)BS3531-11:1991 4 BSI 08-1999 6.2 Austenitic stainless steel wire 6.2.1 Composition Wire used in the manufacture of staples shall be made from austenitic stainless steel in accordance with ISO5832-1 and shall comply with the requirements of the corrosion resistance test specified in ISO58
34、32-1. 6.2.2 Tensile properties When tested in accordance with ISO6892, the tensile properties of the wire in the as-drawn (coiled) condition and after straightening shall be as given in the table. Table Tensile properties of wire made from austenitic stainless steel NOTEThe wire may have been subjec
35、ted to a stress-relieving heat treatment at a temperature not exceeding450 C. 6.3 Cast cobalt-chromium-molybdenum alloy 6.3.1 Composition Cast cobalt-chromium-molybdenum alloy used in the manufacture of staples shall comply with the requirements laid down in ISO5832-4, except for the tensile propert
36、ies of the material which shall comply with the requirements laid down in6.3.2. 6.3.2 Tensile properties When tested in accordance with ISO6892, the tensile strength of the staples in the as-cast condition shall be not less than700N/mm 2 , the proof stress of non-proportional elongation R p0,2shall
37、be not less than500N/mm 2and the percentage elongation after fracture shall be not less than8%. 6.4 Wrought cobalt-chromium-tungsten-nickel alloy 6.4.1 Composition Wrought cobalt-chromium-tungsten-nickel alloy used in the manufacture of staples shall comply with the requirements laid down in ISO5832
38、-5, except for the tensile properties of the material which shall comply with the requirements laid down in6.4.2. 6.4.2 Tensile properties When tested in accordance with ISO6892, the tensile strength of the cold drawn wire used for staples shall be not less than1280N/mm 2and the percentage elongatio
39、n after fracture shall be not less than7%. Figure 2 Parallelism of legs Diameter Minimum tensile strength Percentage elongation after fracture min. As-drawn (coiled) condition Straightened condition mm N/mm 2 N/mm 2 % 1 1,6 2 2,5 3,15 4 1550 1550 1550 1550 1400 1400 1400 1400 1400 1400 1325 1240 3 3
40、 3 3 5 5BS3531-11:1991 BSI 08-1999 5 6.5 Wrought titanium alloy 6.5.1 Composition Wire made of wrought titanium6-aluminium4-vanadium alloy shall comply with the requirements laid down in ISO5832-3, except for the tensile properties of the material which shall comply with the requirements laid down i
41、n6.5.2. 6.5.2 Tensile properties When tested in accordance with ISO6892, the tensile strength of the wires used for staples shall be within the range from1150N/mm 2to1400N/mm 2and the percentage elongation after fracture shall be not less than3%. 7 Finish The surface finish shall be free from burrs,
42、 scratches and other defects visible to the naked eye. NOTEParticular care should be taken with regard to the quality of the surface finish of the curved portions of staples. 8 Packaging Packaging shall be in accordance with ISO6018. 9 Marking of packages Packages shall be marked in accordance with
43、ISO6018. The size of the staples shall be marked in accordance with clause4 of this International Standard.BS3531-11:1991 6 BSI 08-1999 Annex Guidance on use and selection of staples (This Annex does not form an integral part of the Standard.) In clinical practice, these devices may be found to brea
44、k or open out under load. This tendency may be reduced by selecting staples a) of larger cross-sectional area; b) with webs as illustrated in Figure 1b) and Figure 1d); c) made by casting in cobalt-chromium-molybdenum alloy or by forging in other suitable alloys. Extra strength is most important whe
45、n staples are used for epiphyseal arrest, when the number and location of the staples needs special consideration in order to distribute the load. The staples should be inserted with the legs of the staple parallel to the epiphyseal cartilage plate; oblique or stepped (offset) staples are intended t
46、o facilitate this where the bone surface is flared. In order to obtain improved holding, optional surface features, such as barbs or coatings, may be added. The legs of the staple should not be weakened by incorporating these features which may themselves cause problems when the staples are removed
47、at a later stage.BS3531-11:1991 BSI 08-1999 Publication(s) referred to See national foreword.BS3531-11: 1991 ISO8827:1988 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view o
48、n standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendment or revision. Users of BritishStandards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the qua
49、lity of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this BritishStandard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel:02089969000. Fax:02089967400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications sho
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