ISO INTERNATIONAL STANDARD 18192-1 Second edition 2011-03-01 Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test Implants chirurgicaux Usure des protheses totales de remplacement desdisquesintervertebrauxlombaires- Partie 1: Parametres de charge et de déplacement pour essais d'usure et conditions environnementales correspondantes Reference number ISO 18192-1:2011(E) @ ISO 2011 HS unde Not for Resale ISO 18192-1:2011(E) PDF disclaimer 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 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 parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In COPYRIGHTPROTECTEDDOCUMENT @ ISO2011 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 country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 4122749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IsO 2011 - All rights reserved ed without license from IHS Not for Resale ISO 18192-1:2011(E) Contents Page Foreword .iv 1 Scope 2 Normative references 3 Terms and definitions . 4 Principle 5 Reagents and materials . 5.1 Fluid test medium.. 5.2 Test and control specimen. 6 Apparatus 7 Procedure.. 8 Test report. 9 Disposal of test specimen .. 10 Annex A (informative) Statement of rationale for test methods. Annex B (informative) Load and displacement data for cervical implants . 12 Annex C (informative) Load and displacement data for lumbar implants 13 Annex D (informative) Alternative loading conditions . Bibliography.. 25 CopyrightIneationalOganzaandardizaoghtsreseved ili se from IHS Not for Res