ISO INTERNATIONAL STANDARD 13356 Third edition 2015-09-15 Implants for surgery Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TzP) ImplantschirurgicauxProduitsceramiguesabasedezircone tétragonal stabilisée a Iyttrium (Y-TZP) Reference number ISO13356:2015(E) ISO Intermational Organization for Standardization @IS02015 lardization5956617 ted without license from IHS IS013356:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS02015,Published inSwitzerland 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 +4122 749 09 47 [email protected] www.iso.org Intemationaibr PrganizationforStandardization etworking permitted without license from IHS NotforResale, 2015/11/1108:52:33 IS0 13356:2015(E) Contents Page Foreword ..iv Introduction.. ... 1 Scope. 2 Normative references 3 Physical and chemical properties .2 3.1 Test category. 2 3.1.1 General 3.1.2 Category 1 .2 3.1.3 Category2 .2 4 Test methods. ..4 4.1 General 4 4.2 Bulkdensity .4 4.3 Chemical composition 4 4.4 Microstructure .4 4.4.1 Principle 4 4.4.2 Test report. .5 4.4.3 Amount of monoclinic phase .5 4.5 Biaxial flexural strength .6 4.5.1 Principle .6 4.5.2 Apparatus. .6 4.5.3 Preparation of test specimens ..6 4.5.4 Procedure. .7 4.5.5 Calculation of results .8 4.5.6 Test report. .8 4.6 Four-point bending strength .8 4.7 Weibull modulus. 9 4.8 Young's modulus. 9 4.9 Hardness.... .9 4.10 Cyclic fatigue .9 4.10.1 Principle .9 4.10.2 Apparatus. 9 4.10.3 Sample sizeand preparation oftest specimens ..9 4.10.4 Procedure and sample requirement .9 4.10.5 TestReport. .10 4.11 Radioactivity .10 4.11.1 Principle .10 4.11.2 .10 Apparatus. 4.11.3 Sample preparation. ..11 4.11.4 Isotopeidentification-Energycalibration .11 4.11.5 Quantitativeanalysis ..11 4.11.6 Expressionof results .12 4.11.7 Test report. .12 4.12 Accelerated aging test .12 4.12.1 General. .12 4.12.2 Procedure. .12 4.12.3 Evaluation of accelerated aging outcome ..12 Bibliography ..13 iii icensee=Zhejiang Institute of Standardization 5956617 ed without license from IHS