ISO INTERNATIONAL STANDARD 18192-3 First edition 2017-06 Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions Implants chirurgicaux - Usure des protheses totales de remplacementdesdisquesintervertebrauxlombaires Partie 3: Essai d'incidence d'usure et conditions environnementales correspondantes pour I'essai de protheses lombaires sous conditions cinématiquesdéfavorables Reference number IS018192-3:2017(E) rso International Organization for Standardization @ IS0 2017 STANDARDIZATIONC15956617 hout license from IHS IS0 18192-3:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017,PublishedinSwitzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax+412274909 47 copyright@iso.org www.iso.org Intenationai br PrganizationforStandardization icensee-ZHEJIANG INST.OF STANDARDIZRoISQ s1.7 - All rights reserved I by IHS unde etworking permitted without license from IHS IS0 18192-3:2017(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references .1 3 Terms and definitions 4 Principle 5 Reagents and materials. ..2 6 Apparatus. ..3 7 Impingement wear testing methods ..5 7.1 General ..5 7.2 Example of development of load and displacement profiles for extension impingement protocol. .6 7.3 Procedure. 8 Test report ..8 9 Disposal oftestspecimen ..9 Annex A (normative) Wear of spinal disc prostheses - Gravimetric measurement method ..10 Annex B (informative) Justification of the test method ..13 Bibliography .15 iii e=ZHEJIANG INSTOFSTANDARDIZATION C15956617 thout license from IHS