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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 11.040.40 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00
2、2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1997 BSI 02-1999 First published April 1990 Second ed
3、ition May 1997 The following BSI references relate to the work on this standard: Committee reference CH/22 Draft for comment 94/501966 DC 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
4、for osteosynthesis, upon which the following bodies were represented: Association of British Health-Care Industries British Investment Casting Trade Association British Iron and Steel Producers Association British Medical Association British Orthopaedic Association British Surgical Trades Associatio
5、n Department of Health Institution of Sterile Services Management National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37
6、:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 BSI 02-1999i Contents Page Committees responsibleInside front cover National forewordii Forewordiii Introduction1 1Scope1 2Normative references1 3Dimensions and tolerances1 4Material and grades2 5Performance requirements2 6Torque test2
7、7Marking2 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 dimensions of screw keys1 Table 1 Dimensions and tolerances of screw keys1 Table 2 Hardness of screw ke
8、ys2 Table 3 Dimensions and torques used in testing2 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 ii BSI 02-1999 National foreword This British Standard has been prepared by Technical Committee CH/22. It is identical with
9、ISO 8319-1:1996 Orthopaedic instruments Drive connections Part 1: Keys for use with screws with hexagon socket heads, published by the International Organization for Standardization (ISO). It supersedes BS 3531-5.1:1990 which is withdrawn. In BS 3531-5.1:1997 the range for which dimensions and toler
10、ances of screw keys are given is increased to 4,5 mm. The Technical Committee has reviewed the provisions of ISO 6508:1986, 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 ISO 6508 is BS EN 1
11、0109. Product 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 continuing product surveillance, which may be coupled with assessment of a suppliers quality system
12、 against the appropriate standard in the BS EN ISO 9000 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 approp
13、riate 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 Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal oblig
14、ations. Cross-reference International standardCorresponding British Standard ISO 5832-5:1993BS 7252 Metallic materials for surgical implants Part 5:1994 Specification for wrought cobalt-chromium-tungsten-nickel alloy (Identical) ISO 5835:1991BS 3531 Implants for osteosynthesis Part 5 Bone screws and
15、 auxiliary equipment Section 5.3:1991 Specification for the dimensions of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical thread (Identical) ISO 7153-1:1991BS 5194 Surgical instruments Part 1:1991 Specification for stainless steel (Identical) Summary of pages This
16、 document comprises a front cover, an inside front cover, pages i and ii, the ISO title page, page ii, pages 1 to 4 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.
17、 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 ii BSI 02-1999 Foreword ISO (the International Organization for Stan
18、dardization) 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 which a technical committee has been established has the right
19、 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 matters of electrotechnical standardization. Draft Internati
20、onal 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 ISO 8319-1 was prepared by Technical Committee ISO/TC 150, Implan
21、ts for surgery, Subcommittee SC 5, Osteosynthesis. This second edition cancels and replaces the first edition (ISO 8319-1:1986), which has been technically revised. ISO 8319 consists of the following parts, under the general title Orthopaedic instruments Drive connections: Part 1: Keys for use with
22、screws with hexagon socket heads; Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws. Annex A and Annex B of this part of ISO 8319 are for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontr
23、olled Copy, (c) BSI BS 3531-5.1:1997 BSI 02-19991 Introduction 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 a
24、ll clinical aspects; c) the screw key should have adequate strength. The purpose of this part of ISO 8319 is to ensure that this is achieved without imposing undue restriction on design features. 1 Scope This part of ISO 8319 specifies the dimensions, tolerances, mechanical properties and performanc
25、e requirements of the working end of keys to be used for 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 ISO 8319 are suitable for use with screws that conform to ISO 5835. 2 Normative references
26、The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 8319. 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 ISO 8319 are encoura
27、ged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 5832-5:1993, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel all
28、oy. ISO 5835:1991, Implants for surgery Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions1). ISO 6508:1986, Metallic materials Hardness test Rockwell test (scales A B C D E F G H K). ISO 7153-1:1991, Surgical instruments Metallic mater
29、ials Part 1: Stainless steel. 3 Dimensions and tolerances The dimensions and tolerances shall be as specified in Figure 1 and Table 1. Table 1 Dimensions and tolerances of screw keys 1) See Annex A for information on the interrelationship between International Standards dealing with bone screws, bon
30、e plates and relevant tools. Figure 1 Designation of dimensions of screw keys Dimensions in millimetres Screws in accordance with ISO 5835 Screw key dimensions sel nom.max.min.max.min.min. HA 1,5; HA 2,01,51,5001,4751,6901,6502 HA 2,7; HA 3,5; HB 4;2,52,5002,4752,8402,8004 HA 4; HA 4,5; HA 5; HB 6;
31、HB 6,5;3,53,5003,4703,9803,9325 4,54,5004,4705,1305,0826 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 2 BSI 02-1999 4 Material and grades Screw keys shall be made of one of the following metals: a) martensitic stainless s
32、teel (for example, in accordance with grade reference letters C, D, H or I of ISO 7153-1). b) cold-worked wrought cobalt-chromium-tungsten-nickel alloy in accordance with ISO 5832-5, or other equivalent cobalt alloy. 5 Performance requirements 5.1 Hardness The Rockwell hardness shall be within the r
33、ange given in Table 2 when tested in accordance with ISO 6508. Table 2 Hardness of screw keys 5.2 Torque test requirements Following the application of the minimum test torque as given in clause 6 and Table 3, the key for screws with hexagon socket heads shall not fracture or show permanent deformat
34、ion. 6 Torque test 6.1 Apparatus 6.1.1 Female hexagon socket adaptor, with an opening in accordance with Table 3. The socket adaptor shall be hardened to 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
35、torque as given in Table 3. Do not jerk or strike the key when testing. Apply the load gradually until the minimum testing torque is reached. 7 Marking The key shall be permanently and legibly marked with the following information: a) size of the screw (code and thread diameter, in accordance with I
36、SO 5835) with which it is intended to be used; b) manufacturers name or trademark; c) number of this part of ISO 8319, if there is space available; d) material of which it is made, if there is space available. Table 3 Dimensions and torques used in testing Material Rockwell hardness HRC Stainless st
37、eel48 to 54 Wrought cobalt-chromium- tungsten-nickel alloy 45 to 50 Width across flats, sDepth of key engagement Torque KeyFemale hexagon socket adaptor nom.nom.tol.min.min. mmmmmmNm 1,51,5+ 0,046 + 0,006 0,90,7 2,52,51,23,8 3,53,5 + 0,058 + 0,010 2,89,7 4,54,5 + 0,058 + 0,010 3,812 Licensed Copy: s
38、heffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 BSI 02-19993 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools It has been decided that the set of International Stand
39、ards 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). A simplified schematic guide illustrating the interrelati
40、onship 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 preparation Holes and slotsISO 5836ISO 9269 Plates Mechanical r
41、equirements In preparationIn preparation Driving tools Keys and screwdrivers Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-5.1:1997 4 BSI 02-1999 Annex B (informative) Bibliography 1 ISO 5836:1988, Implants for surgery Metal bone p
42、lates Holes corresponding to screws with asymmetrical 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 connection
43、s Part 2: Screwdrivers for single slot head screws, 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 t
44、o screws with conical under-surface. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 389 Chiswick High Road London W4 4AL |
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