ISO INTERNATIONAL STANDARD 6474-2 Second edition 2019-03 Implants for surgery Ceramic materials - Part 2: Composite materials based on a high purity alumina matrix with zirconia reinforcement Implants chirurgicaux Produits céramiques - Partie 2: Materiaux composites a matrice alumine de haute pureté renforcée par des grains de zircone Reference number ISO 6474-2:2019(E) os1 @ IS0 2019 IS0 6474-2:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2019 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 6474-2:2019(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Normative references 3 Terms and Definitions ..3 4 Classification .3 4.1 Material types .3 4.2 Test categories. .3 4.2.1 General. 3 4.2.2 Category 1: required tests representative for periodical production control 4.2.3 Category 2: required tests representative for the general material specification...3 4.3 Material properties 4 5 Preparation of specimens. ..5 6 Test methods. 6.1 Bulkdensity .6 6.1.1 General 6.1.2 Calculation of ultimate density .6 6.1.3 Empirical determination of the ultimate density ..6 6.2 Chemical composition .7 6.3 Microstructure .7 6.4 Strength properties .8 6.4.1 General. .8 6.4.2 Biaxial flexural strength 6.4.3 4-point flexural strength ..8 6.4.4 Weibull modulus .9 6.5 Radioactivity 9 6.6 Fracture toughness. ..9 6.6.1 General .9 6.6.2 SEVNB. .9 6.6.3 SEPB. .9 6.6.4 SCF .9 6.7 Hardness. 10 6.8 snnpou s,Suno .10 6.9 Cyclicfatigue ..10 6.10 Accelerated ageing. .10 6.10.1 General 10 6.10.2 Strength .11 6.10.3 Cyclic fatigue ..1 6.10.4 Wear. ..11 Bibliography ..12 IS0 2019 - All rights reserved iii