ISO INTERNATIONAL STANDARD 15309 First edition 2013-12-01 Implants for surgery Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices Implants chirurgicaux - Calorimétrie par balayage differentiel des polyethercetones, polymeres et composes pour I'utilisation dans les dispositifs medicaux implantables Reference number ISO 15309:2013(E) LSO @IS02013 I without license from IHS Not for Resale IS0 15309:2013(E) COPYRIGHTPROTECTEDDOCUMENT ISO2013 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 Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland @ IS0 2013 - All rights reserved No reproductic networking permited without license from IHS Not for Resale IS0 15309:2013(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Apparatus and materials. 2 4.1 Differential scanning calorimeter (DSC) .2 4.2 Sample pans. .3 4.3 Balance.. .3 4.4 Reference materials .3 4.5 Gas supply .3 5 Test specimens. ..3 6 Test conditions and conditioning of specimens .3 6.1 Test conditions. 6.2 Conditioning of specimens .3 7 Instrument calibration. .3 7.1 Temperature calibration 7.2 Energy calibration. .3 8 Procedure .4 8.1 Baseline measurement. 8.2 Sample preparation 4 8.3 Inserting the sample pans ..4 8.4 Temperature scanning programme .4 8.5 Examining the specimen. .4 8.6 Data analysis ..5 9 Test report and typical properties. .5 10 Precision iii ded by IHS under license with IS ed without license from IHS Not for Resale