ISO INTERNATIONAL STANDARD 15142-2 First edition 2003-08-01 Implants for surgery Metal intramedullary nailing systems Part 2: Locking components Implantschirurgicaux-Systemes d'enclouage intramedullaire en metal- Partie 2:Elementsdefixation Reference number ISO 15142-2:2003(E) ISO ISO2003 ense with ISt Not for Resale ISO 15142-2:2003(E) PDFdisclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The IsO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation C ISO2003 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 memberbody in the countryofthe requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax +4122749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland Copyright Intemational Organizaton for Standardizatin ISO2003-All rights reserved No reproductic or networking permitted without license from IHS Not for Resale ISO 15142-2:2003(E) Contents Page Foreword iv Introduction 1 Scope... 2 Normativereferences.. 3 Termsanddefinitions 4 Classificationanddesignation... 5 Materials. 6 Surfacerequirements. 7 Marking.. 8 Product labelling.. 9 Drive connections for insertion and removal of locking components.. Bibliography ili e with ISt Se from IHS Not for Re ISO 15142-2:2003(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (isOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughIso 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/lEC Directives, Part 2 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. ISO15142-2was prepared by Technical Committee ISO/TC 150, Implants for surgery,Subcommittee SC 5, Osteosynthesisandspinaldevices nailing systems: Part1:Intramedullarynails Part2:Lockingcomponents Part3:Connectiondevicesandreamerdiametermeasurements ISO2003-All rights reserved Copyri Not for Resale ISO 15142-2:2003(E) Introduction due to fractures or disease or both. Medical and engineering considerations influence the design of the different devices and the choice of a device for a particular clinical situation. This part of IsO 15142 addresses the locking components used for lockable metal intramedullary nails. Because of the wide variety of the devices, classification of the locking components is provided. stabilization dghsred V Not for Resale NrodctioneworkingmitewthutlicenefrmHS Not for Resale INTERNATIONALSTANDARD ISO15142-2:2003(E) Implants for surgery Metal intramedullary nailing systems Part 2: Locking components Scope This part of IsO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization intramedullary nails. It is applicable to all