ISO Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters

Transcription

1 INTERNATIONAL STANDARD ISO Second edition Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters Instruments de forage orthopédiques Partie 1: Tarauds, forets et fraises à lamer Reference number ISO 2012

2 ISO 2012 COPYRIGHT PROTECTED DOCUMENT 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 either ISO at the address below or ISO s member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel Fax copyright@iso.org Web Published in Switzerland ii

3 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 which 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 matters of electrotechnical 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 bodies 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 any or all such patent rights. ISO 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 :1991), which has been technically revised. ISO 9714 consists of the following parts, under the general title Orthopaedic drilling instruments: Part 1: Drill bits, taps and countersink cutters iii

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5 INTERNATIONAL STANDARD Orthopaedic drilling instruments Part 1: Drill bits, taps and countersink cutters 1 Scope This part of ISO 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 NOTE The interrelationship of International Standards dealing with 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 selfdrilling guide pins. 2 Normative references The following referenced documents are indispensable for the application of 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 undersurface of head, asymmetrical 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. 1

6 Table 1 Steel grades and chemical compositions Steel grade in accordance with: Chemical composition % a ISO : 1991 ref. letter EN : 2005 AISI b ASTM F899: 2011 C Si Mn P S Cr Mo Ni Other elements Austenitic stainless steels M , ,045 0,03 17 to 19 8 to 11 N: 0,10 N , ,06 0,15 to 0,35 17 to 19 0,7 c 8 to 10 O , ,045 0,03 16 to 18 6 to 8 P , ,045 0,03 16,5 to 18,5 2 to 2,5 10,5 to 13,5 N: 0, or L 0, ,045 0,03 16 to 19 2,0 to 3 10,0 to 15 Martensitic steels 420A 0,16 to 0, ,04 0,03 12 to B 0,26 to 0, ,04 0,03 12 to 14 1 D 420C 420C 0,42 to 0, ,04 0,03 12,5 to 14,5 1 H 0,35 to 0, ,045 0,03 14 to 15 0,4 to 0,6 V: 0,1 to 0,15 I 0,42 to 0, ,045 0,03 12 to 15 0,45 to 0,90 V: 0,1 to 0,15 R B 0,85 to 0, ,045 0,03 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 16 to 18 0,75 S 440A 440A 0,60 to 0, ,040 0,03 16 to 18 0,75 a Chemical composition data are extracted from ISO :1991, ASTM F899:2011, AISI 316L and EN :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