1、BRITISH STANDARD BS 3531-5.1: 1997 ISO 8319-1: 1996 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.1 Specification for keys for use with screws having heads with hexagon socket ICS 11.040.40BS3531-5.1:1997 This British Standard, having been prepared under the direc
2、tion of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15May1997 BSI02-1999 First published April1990 Second edition May1997 The following BSI references relate to the work on this standard: Committee reference CH/22 Draft f
3、or comment 94/501966DC ISBN 0 580 26665 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/22, Implants for osteosynthesis, upon which the following bodies were represented: Association of British Health-Care Industries
4、 British Investment Casting Trade Association British Iron and Steel Producers Association British Medical Association British Orthopaedic Association British Surgical Trades Association Department of Health Institution of Sterile Services Management National Association of Theatre Nurses Royal Coll
5、ege of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-5.1:1997 BSI 02-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword iii Introduction 1 1 Scope 1 2 Normative references 1 3 Di
6、mensions and tolerances 1 4 Material and grades 2 5 Performance requirements 2 6 Torque test 2 7 Marking 2 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools 3 Annex B (informative) Bibliography 4 Figure 1 Designation of dimens
7、ions of screw keys 1 Table 1 Dimensions and tolerances of screw keys 1 Table 2 Hardness of screw keys 2 Table 3 Dimensions and torques used in testing 2BS3531-5.1:1997 ii BSI 02-1999 National foreword This British Standard has been prepared by Technical Committee CH/22. It is identical with ISO8319-
8、1:1996 Orthopaedic instruments Drive connections Part1: Keys for use with screws with hexagon socket heads, published by the International Organization for Standardization (ISO). It supersedes BS3531-5.1:1990 which is withdrawn. In BS3531-5.1:1997 the range for which dimensions and tolerances of scr
9、ew keys are given is increased to 4,5mm. The Technical Committee has reviewed the provisions of ISO6508:1986, 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 standard for ISO6508 is BSEN10109. Product cer
10、tification. 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 continuing product surveillance, which may be coupled with assessment of a suppliers quality system against the appr
11、opriate standard in the BSENISO9000 series. Enquiries as to the availability of third party certification 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
12、list of Association members. 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. Cross-refere
13、nce International standard Corresponding British Standard ISO 5832-5:1993 BS 7252 Metallic materials for surgical implants Part 5:1994 Specification for wrought cobalt-chromium-tungsten-nickel alloy (Identical) ISO 5835:1991 BS 3531 Implants for osteosynthesis Part 5 Bone screws and auxiliary equipm
14、ent Section 5.3:1991 Specification for the dimensions of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical thread (Identical) ISO 7153-1:1991 BS 5194 Surgical instruments Part 1:1991 Specification for stainless steel (Identical) Summary of pages This document compri
15、ses a front cover, an inside front cover, pagesi andii, theISOtitle page, pageii, pages1 to4 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 theinside front cover.BS3531-5.1:1997 ii BSI 0
16、2-1999 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for wh
17、ich a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
18、matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote. International Standard ISO831
19、9-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis. This second edition cancels and replaces the first edition (ISO8319-1:1986), which has been technically revised. ISO 8319 consists of the following parts, under the general title Orthopaedic
20、instruments Drive connections: Part1: Keys for use with screws with hexagon socket heads; Part2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws. Annex A and Annex B of this part of ISO8319 are for information only.BS3531-5.1:1997 BSI 02-1999 1 Intr
21、oduction Essential requirements for all varieties of screw keys are that a) the working end of the screw key should accurately engage the head of the screw; b) the materials used for the manufacture of the screw keys should be satisfactory from all clinical aspects; c) the screw key should have adeq
22、uate strength. The purpose of this part of ISO8319 is to ensure that this is achieved without imposing undue restriction on design features. 1 Scope This part of ISO8319 specifies the dimensions, tolerances, mechanical properties and performance requirements of the working end of keys to be used for
23、 inserting and removing metal bone screws with hexagon drive sockets, used as surgical implants. Screw keys with a working end specified in this part of ISO8319 are suitable for use with screws that conform to ISO5835. 2 Normative references The following standards contain provisions which, through
24、reference in this text, constitute provisions of this part of ISO8319. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO8319 are encouraged to investigate the possibility of applying the most rece
25、nt editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO5832-5:1993, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO5835:1991, Implants for surgery Metal bone screws with
26、 hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions 1) . ISO6508:1986, Metallic materials Hardness test Rockwell test (scales A B C D E F G H K). ISO7153-1:1991, Surgical instruments Metallic materials Part 1: Stainless steel. 3 Dimensions and tolerances The
27、dimensions and tolerances shall be as specified inFigure 1 and Table 1. Table 1 Dimensions and tolerances of screw keys 1) SeeAnnex A for information on the interrelationship between International Standards dealing with bone screws, bone plates and relevant tools. Figure 1 Designation of dimensions
28、of screwkeys Dimensions in millimetres Screws in accordance with ISO 5835 Screw key dimensions s e l nom. max. min. max. min. min. HA 1,5; HA 2,0 1,5 1,500 1,475 1,690 1,650 2 HA 2,7; HA 3,5; HB 4; 2,5 2,500 2,475 2,840 2,800 4 HA 4; HA 4,5; HA 5; HB 6; HB 6,5; 3,5 3,500 3,470 3,980 3,932 5 4,5 4,50
29、0 4,470 5,130 5,082 6BS3531-5.1:1997 2 BSI 02-1999 4 Material and grades Screw keys shall be made of one of the following metals: a) martensitic stainless steel (for example, in accordance with grade reference letters C, D, H orI of ISO7153-1). b) cold-worked wrought cobalt-chromium-tungsten-nickel
30、alloy in accordance with ISO5832-5, or other equivalent cobalt alloy. 5 Performance requirements 5.1 Hardness The Rockwell hardness shall be within the range given inTable 2 when tested in accordance with ISO6508. Table 2 Hardness of screw keys 5.2 Torque test requirements Following the application
31、of the minimum test torque as given in clause6 andTable 3, the key for screws with hexagon socket heads shall not fracture or show permanent deformation. 6 Torque test 6.1 Apparatus 6.1.1 Female hexagon socket adaptor, with an opening in accordance withTable 3. The socket adaptor shall be hardened t
32、o a Rockwell hardness higher than that of the screw key. 6.2 Procedure Insert the working end of the key in the adaptor and apply the corresponding torque as given inTable 3. Do not jerk or strike the key when testing. Apply the load gradually until the minimum testing torque is reached. 7 Marking T
33、he key shall be permanently and legibly marked with the following information: a) size of the screw (code and thread diameter, in accordance with ISO5835) with which it is intended to be used; b) manufacturers name or trademark; c) number of this part of ISO8319, if there is space available; d) mate
34、rial of which it is made, if there is space available. Table 3 Dimensions and torques used in testing Material Rockwell hardness HRC Stainless steel 48 to 54 Wrought cobalt-chromium- tungsten-nickel alloy 45 to 50 Width across flats, s Depth of key engagement Torque Key Female hexagon socket adaptor
35、 nom. nom. tol. min. min. mm mm mm Nm 1,5 1,5 + 0,046 + 0,006 0,9 0,7 2,5 2,5 1,2 3,8 3,5 3,5 + 0,058 + 0,010 2,8 9,7 4,5 4,5 + 0,058 + 0,010 3,8 12BS3531-5.1:1997 BSI 02-1999 3 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tool
36、s It has been decided that the set of International Standards dealing with bone screws, bone plates and relevant tools should be divided into two parallel series, based on the essentially different designs of the threads of the bone screws (HA and HB type screws as opposed to HC to HD type screws).
37、A simplified schematic guide illustrating the interrelationship between screws, plates and tools covered by the two parallel series of International Standards is given below. Screws Thread Head undersurface Drive connection Mechanical requirements ISO 6475 Breaking torque/angle of rotation In prepar
38、ation Holes and slots ISO 5836 ISO 9269 Plates Mechanical requirements In preparation In preparation Driving tools Keys and screwdriversBS3531-5.1:1997 4 BSI 02-1999 Annex B (informative) Bibliography 1 ISO5836:1988, Implants for surgery Metal bone plates Holes corresponding to screws with asymmetri
39、cal thread and spherical under-surface. 2 ISO 6475:1989, Implants for surgery Metal bone screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods. 3 ISO 8319-2:1986, Orthopaedic instruments Drive connections Part2: Screwdrivers for single slot head screws,
40、 screws with cruciate slot and cross-recessed head screws. 4 ISO 9268:1988, Implants for surgery Metal bone screws with conical under-surface of head Dimensions. 5 ISO 9269:1988, Implants for surgery Metal bone plates Holes and slots corresponding to screws with conical under-surface.blankBSI 389 Ch
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