1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication BS ISO 9714-1:2012 Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cuttersBS ISO 9714-1:2012 BRITISH STANDARD National foreword This British Standard
2、 is the UK implementation of ISO 9714-1:2012. It supersedes BS 3531-5.7:1991 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150/5, Surgical Implants - Osteosynthesis and spinal devices. A list of organizations represented on this committee can be
3、obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012 ISBN 978 0 580 71400 9 ICS 11.040.30; 11.0
4、40.40 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2012. Amendments issued since publication Date T e x t a f f e c t e dBS ISO 9714-1:2012 ISO 2012
5、Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters Instruments de forage orthopdiques Partie 1: Tarauds, forets et fraises lamer INTERNATIONAL STANDARD ISO 9714-1 Second edition 2012-06-01 Reference number ISO 9714-1:2012(E)BS ISO 9714-1:2012ISO 9714-1:2012(E) ii ISO 2
6、012 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2012 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, without permission in writing from eit
7、her ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandBS ISO 9714-1:2012ISO 9714-1:2012(E) Foreword ISO (the
8、 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 which a technical committe
9、e 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 matters of electrotechni
10、cal standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member b
11、odies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying a
12、ny or all such patent rights. ISO 9714-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices. This second edition cancels and replaces the first edition (ISO 9714-1:1991), which has been technically revised. ISO 9714 consists of
13、the following parts, under the general title Orthopaedic drilling instruments: Part 1: Drill bits, taps and countersink cutters ISO 2012 All rights reserved iiiBS ISO 9714-1:2012BS ISO 9714-1:2012Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters 1 Scope This part of I
14、SO 9714 specifies materials and mechanical properties, and dimension and marking requirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws specified in ISO 5835. NOTE The interrelationship of International Standards dealing with
15、 bone screws, bone plates and relevant tools is shown in Annex A. This part of ISO 9714 is not applicable to self-drilling pins, such as those used in external fixation, and self- drilling guide pins. 2 Normative references The following referenced documents are indispensable for the application of
16、this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5835:1991, Implants for surgery Metal bone screws with hexagonal drive connection, spherical under- surface of head, asym
17、metrical thread Dimensions 3 Materials and dimensions 3.1 Material Drill bits, taps and countersink cutters may be made from metal complying with the requirements given in Table 1. INTERNATIONAL STANDARD ISO 9714-1:2012(E) ISO 2012 All rights reserved 1BS ISO 9714-1:2012ISO 9714-1:2012(E) Table 1 St
18、eel grades and chemical compositions Steel grade in accordance with: Chemical composition %a ISO 7153-1: 1991 ref. letter EN 10088- 3: 2005 AISIb ASTM F899: 2011 C max. Si max. Mn max. P max. S Cr Mo Ni Other elements Austenitic stainless steels M 1.4301 304 304 0,07 1 2 0,045 0,03 max. 17 to 19 8 t
19、o 11 N: 0,10 max. N 303 303 0,12 1 2 0,06 0,15 to 0,35 17 to 19 0,7 max.c 8 to 10 O 1.4310 301 301 0,15 1 2 0,045 0,03 max. 16 to 18 6 to 8 P 1.4408 316 316 0,07 1 2 0,045 0,03 max. 16,5 to 18,5 2 to 2,5 10,5 to 13,5 N: 0,10 max. 1.4404 or 1.4435 316L 0,03 1 2 0,045 0,03 max. 16 to 19 2,0 to 3 10,0
20、to 15 Martensitic steels 420A 0,16 to 0,25 1 1 0,04 0,03 max. 12 to 14 1 max. 420B 0,26 to 0,35 1 1 0,04 0,03 max. 12 to 14 1 max. D 420C 420C 0,42 to 0,50 1 1 0,04 0,03 max. 12,5 to 14,5 1 max. H 0,35 to 0,4 1 1 0,045 0,03 max. 14 to 15 0,4 to 0,6 V: 0,1 to 0,15 I 0,42 to 0,55 1 1 0,045 0,03 max. 1
21、2 to 15 0,45 to 0,90 V: 0,1 to 0,15 R 1.4112 440B 0,85 to 0,95 1 1 0,045 0,03 max. 17 to 19 0,9 to 1,3 V: 0,07 to 0,12 440B 0,75 to 0,95 1 0,04 0,03 max. 16 to 18 0,75 max. S 440A 440A 0,60 to 0,75 1 1 0,040 0,03 max. 16 to 18 0,75 max. aChemical composition data are extracted from ISO 7153-1:1991,
22、ASTM F899:2011, AISI 316L and EN 10088-3:2005. b American Iron and Steel Institute. c At the option of the steelmaker, the Mo content for steel grade N can be up to 0,7 %. 2 ISO 2012 All rights reservedBS ISO 9714-1:2012ISO 9714-1:2012(E) 3.2 Dimensions 3.2.1 Drill bits The diameter of the drill bit
23、 shall be as given in Table 2. The point angle shall be (90 10). 3.2.2 Taps The core diameter and outside diameter shall be as given in Table 2. The thread form and pitch shall be that of the appropriate screw as specified in ISO 5835. 3.2.3 Countersink cutters The diameter of the pin and cutter hea
24、d shall be as given in Table 2 and Figure 1. The cutter shall be either of conical form with an angle of (90 2) or of spherical form. Table 2 Dimensions of drill bits, taps and countersink cutters Dimensions in millimetres Screws (These data are extracted from ISO 5835 and are given here for informa
25、tion) Drill bits Taps a Countersink cutters ISO 5835:1991 code Nominal diameter Core diameter Pitch Diameter of drill intended for drilling clearance hole Diameter of drill intended for drilling pilot hole Outside diameter Core diameter Pitch Pin diameter d 1 Cutter head diameter d 2 0 - 0,02 0 - 0,
26、02 0 - 0,15 0 - 0,15 0 - 0,1 Screws with shallow head HA 1,5 1,5 1,1 0,5 1,5 1,1 1,5 1,1 0,5 1,1 4 HA 2 2 1,3 0,6 2 1,5 2 1,3 0,6 1,1 4 HA 2,7 2,7 1.9 1 2,7 2 2,7 1,9 1 2,5 6 HA 3,5 3,5 2,4 1,25 3,5 2,5 3,5 2,4 1,25 2,5 6 HA 4 4 2,9 1,5 4 3 4 2,9 1,5 2,5 6 HA 4,5 4,5 3 1,75 4,5 3,2 4,5 3 1,75 3,2 8
27、HA 5 5 3,5 1,75 5 3,7 5 3,5 1,75 3,2 8 Screws with deep thread HB 4 4 1,9 1,75 Not applicable to HB screws 2 4 1,9 1,75 Not required for HB screws HB 6,5 6,5 3 2,75 3,2 6,5 3 2,75 aIt is recommended that the maximum variation from the theoretical profile at any point on the thread form should not ex
28、ceed: 0,050 mm for HA 1,5 and HA 2; 0,075 mm for HA 2,7 to HA 5; 0,075 mm for HB 4 and HB 6,5. ISO 2012 All rights reserved 3BS ISO 9714-1:2012ISO 9714-1:2012(E) Figure 1 Countersink cutter 4 Marking 4.1 Drill bits Drill bits shall be marked with the diameter of the bit expressed in millimetres. 4.2
29、 Taps Taps shall be marked with the code and nominal size of the screw, as specified in ISO 5835:1991, with which they are intended to be used. 4.3 Countersink cutters Countersink cutters shall be marked with the nominal sizes of the screw, as specified in ISO 5835:1991, with which they are intended
30、 to be used. 4 ISO 2012 All rights reservedBS ISO 9714-1:2012ISO 9714-1:2012(E) Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools lt has been decided that the set of International Standards dealing with bone screws, bone plate
31、s and relevant tools should be divided into two parallel series. The basis of the division into two series is the essentially different designs of the screw threads of the bone screws (HA and HB type screws as opposed to HC and HD type screws). A simplified schematic guide illustrating the interrela
32、tionship between screws, plates and tools covered by the parallel series of International Standards is given in Figure A.1. ISO 2012 All rights reserved 5BS ISO 9714-1:2012ISO 9714-1:2012(E) Figure A.1 Interrelationship between screws, plates and tools covered by the parallel series of International
33、 Standards 6 ISO 2012 All rights reservedBS ISO 9714-1:2012ISO 9714-1:2012(E) Bibliography 1 ISO 4957, Tool steels 2 ISO 5836, Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical under-surface 3 ISO 6475, Implants for surgery Metal bone screws
34、with asymmetrical thread and spherical under- surface Mechanical requirements and test methods 4 ISO 7153-1:1991, Surgical instruments Metallic materials Part 1: Stainless steel 5 ISO 8319-1, Orthopaedic instruments Drive connections Part 1: Keys for use with screws with hexagon socket heads 6 ISO 8
35、319-2, Orthopaedic instruments Drive connections Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws 7 ISO 9268, Implants for surgery Metal bone screws with conical under-surface of head Dimensions 8 ISO 9269, lmplants for surgery Metal bone pla
36、tes Holes and slots corresponding to screws with conical under-surface 9 ISO 9585, Implants for surgery Determination of bending strength and stiffness of bone plates 10 ISO 10664, Hexalobular internal driving feature for bolts and screws 11 ISO 14583, Hexalobular socket pan head screws 12 EN 10088-
37、3:2005, Stainless steels Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resisting steels for general purposes 13 ASTM F899: 2011, Standard Specification for Wrought Stainless Steels for Surgical Instruments ISO 2012 All rights re
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