ISO INTERNATIONAL STANDARD 5834-2 Fifth edition 2019-02 Implants for surgery Ultra-high molecular-weight polyethylene Part 2: Moulded forms Implants chirurgicaux - Polyéthylene a tres haute masse moleculaire- Partie 2: Produits sous forme moulee Reference number IS0 5834-2:2019(E) ISO @ IS0 2019 IS0 5834-2:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO 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: +4122 749 0111 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 5834-2:2019(E) Contents Page Foreword ..iv 1 Scope .1 2 Normative references ..1 3 Terms and definitions 4 Classification 5 Material. ..1 6 Manufacturing requirements .2 7 Requirements .2 7.1 Physical properties .2 7.2 Particulate matter.. .2 8 Test methods. .2 8.1 Test conditions .2 8.2 Density 3 8.3 Tensile testing. 3 8.3.1 General 3 8.3.2 Tensile stress at yield. .3 8.3.3 Tensile stress at break .3 8.3.4 Elongation at break. .3 8.4 Notched impact strength .3 8.5 Sample area for particulate matter 3 9 Identification marking ..3 10 Test certificate ..3 11 Labelling. ..4 Bibliography .5 @ IS0 2019 - All rights reserved iii