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1、 IS0 8317-1 96 m 4051903 0660325 36T = INTERNATIONAL STANDARD IS0 8319-1 Second edition 1996-05-1 5 Orthopaedic instruments - Drive connections - Part 1: Keys for use with screws with hexagon socket heads Instruments orthopdiques - Raccords dentranement - Partie 7: Cls utiliser pour les vis tte six
2、pans creux Reference number IS0 831 9-1 1 1 996(E) IS0 8319-1 9b m 4851903 Ob60326 2Tb m IS0 831 9-1 :1996( E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards i
3、s normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be rep- resented on that committee. International organizations, governmental and non-governmental, in liaison with KO, also take pa
4、rt in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Stan
5、dard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 831 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 (IS0 831 9-1 :1986), whi
6、ch has been technically revised. IS0 8319 consists of the following parts, under the general title Ortho- paedic instruments - Drive connections: - - Part 1: Keys for use with screws with hexagon socket heads Part.?: Screwdrivers for single slot head screws, screws with cru- ciste slot and cross-rec
7、essed head screws Annexes A and B of this part of IS0 8319 are for information only. IS0 1996 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, withou
8、t permission in writing from the publisher, International Organization for Standardization Case postale 56 CH-1 21 1 Genve 20 Switzerland Printed in Switzerland -,-,- IS0 8319-1 96 W 4853903 0bb0327 132 0 IS0 IS0 8319-1:1996(E) Introduction Essential requirements for all varieties of screw keys are
9、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 adequate strength. The purpose of this part of IS08319 is to ensure that
10、 this is achieved without imposing undue restriction on design features. . 111 IS0 8319-1 96 4851903 O660328 079 INTERNATIONAL STANDARD IS0 IS0 8319-1:1996(E) Orthopaedic instruments - Drive connections - Part 1: Keys for use with screws with hexagon socket heads 1 Scope This part of IS0 8319 specif
11、ies the dimensions, tol- erances, mechanical properties and performance 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 IS0 8319 are suitable
12、 for use with screws that conform to IS0 5835. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 8319. At the time of publication, the editions indicated were valid. All standards are subject to revision
13、, and parties to agreements based on this part of IS0 8319 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 5832-5: 1993, Implants for surgery
14、 - Metallic materials - Part 5: Wrought cobalt-chromium- tungsten-nickel alloy. IS0 5835:1991, Implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Di- mensionsi ). IS0 6508: 1986, Metallic materials - Hardness test - Rockwe
15、ll test (scales A - B - C- D - E - F - G - H - K). IS0 7 1 53-1 :I 991, Surgical instruments - Metallic materials - Part 7: Stainless steel. 3 Dimensions and tolerances The dimensions and tolerances shall be as specified in figure 1 and table 1. r L Shank and handle contiguration optional Y Edaes ma
16、y be rounded L - or chamfered e s I Peak-to-peak diameter of the hexagon Width across flats of the hexagon Length of the hexagonal part Figure 1 - Designation of dimensions of screw keys 1) See annex A for information on the interrelationship between International Standards dealing with bone screws,
17、 bone dates and relevant tools. 1 IS0 8319-1 96 Y851903 0660329 TO5 Width across flats, s I Female hexagon socket adaptor Key IS0 831 9-1 :1996(E) Depth of key engagement (9 IS0 tol. I “Orn. mm I Table 1 - Dimensions and tolerances of screw keys Dimensions in millimetres Screws in accordance with IS
18、0 5835 I min. min. mm N.m 4 Material and grades 1 3 2.5 3 . 5 4.5 Screw keys shall be made of one of the following metals: a) martensitic stainless steel (for example, in accord- ance with grade reference letters C, D, H or I of b) cold-worked wrought cobalt-chromium-tungsten- nickel alloy in accord
19、ance with IS0 5832-5, o r other equivalent cobalt alloy. IS0 7 1 53-1 1. 1.5 + 0,046 0 . 9 0 . 7 2 . 5 1,2 3 . 8 + 0,006 + 0,058 + 0,058 4 . 5 + 0,010 3,8 3 . 5 + 0,010 2 . 8 9.7 12 5.2 Torque test requirements Following the application of the minimum test torque as given in clause 6 and table 3, th
20、e key for screws with hexagon socket heads shall not fracture or show permanent deformation. 6 Torquetest 6.1 Apparatus 5 Performance requirements 5.1 Hardness The Rockwell hardness shall be within the range given in table 2 when tested in accordance with IS0 6508. Table 2 - Hardness of screw keys I
21、 I Rockwell hardness HRC Material I Stainless steel 48 to 54 45 to 50 Wrought cobalt-chromium- tungsten-nickel alloy 6.1.1 Female hexagon socket adaptor, with an opening in accordance with table 3. The socket adap- tor shall be hardened to a Rockwell hardness higher than that of the screw key. 6.2 P
22、rocedure Insert the working end of the key in the adaptor and apply the corresponding 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. Table 3 - Dimensions and torques used in testing - - - Torque 2 -,-,- IS
23、0 IS0 8319-1 96 m 4851903 Ob60330 727 m IS0 8319-1:1996(E) 7 Marking The key shall be permanently and legibly marked with the following information: available; b) manufacturers name or trademark; c) number of this part of IS0 8319, if there is space a) size of the screw (code and thread diameter. in
24、 accordance with IS0 5835) with which it is in- tended to be used; dl materia, of which it is made, if there is space available. 3 -,-,- IS0 8319-1 9b = Y851903 Obb0331 bb3 IS0 831 9-1 :1996( E) Q IS0 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone p
25、lates and relevant tools 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
26、HC to HD type screws). 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 Plates Driving tools Thread Head undersurface Drive connection Mechanical requirements Holes an
27、d slots Mechanical requirements Keys and screwdrivers IS0 5835 HA HB Spherical Hexagon IS0 6475 Breaking torque/ angle of rotation IS0 5836 In preparation IS0 8319-1 Hexagonkeys IS0 9268 HC HO 90*/ Conical Single Cruciate Cross- slot slot recessed head In preparation IS0 9269 In preparation IS0 8319
28、-2 - Screwdrivers 4 -,-,- Annex B (informative) Bibliography l IS0 5836:1988, Implants for surgery - Metal bone plates - Holes corresponding to screws with asymmetrical thread and spherical under- surface. 2 IS0 6475:1989, Implants for surgery - Metal bone screws with asymmetrical thread and spheric
29、al under-surface - Mechanical require- ments and test methods. 1 3 1 IS0 831 9-2: 1986, Orthopaedic instruments - Drive connections - Part 2: Screwdrivers for sin- IS0 8319-1:1996(E) gle slot head screws, screws with cruciate slot and cross-recessed head screws. I 4 1 IS0 9268:1988, Implants for sur
30、gery - Metal bone screws with conical under-surface of head - Dimensions. 1 5 1 IS0 9269:1988, Implants for surgery - Metal bone plates - Holes and slots corresponding to screws with conical under-surface. 5 -,-,- IS0 8339-3 96 4853903 Obb0333 43b IS0 8319-1 11 996( E) ICs 11.040.40 Descriptors: medical equipment. orthopaedic implants, hexagonal head screws, socket head screws, surgical equipment, wrenches, specifications, dimensions, dimensional tolerances, tests, torsion tests, marking. Price based on 5 pages -,-,-