ISO INTERNATIONAL STANDARD 13781 Second edition 2017-07 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) In vitro degradation testing Implants chirurgicauxHomopolymeres,copolymeres etmelanges sur poly(lactide) -Essais de degradation in vitro Referencenumber ISO13781:2017(E) iso Intemational Organization for Standardization ZHEJIANG INST OF STANDARDIZATION C1 5956617 @IS02017 ted without license from IHS IS0 13781:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS02017,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 Uicensee-ZHEJIANG INST OF STANDARDIZoISQ 3q,7 -All rights reserved etworking permitted without license from IHS NotforResale, 2017/9/2705:33:26 IS0 13781:2017(E) Contents Page Foreword ..iv Introduction.. 1 Scope. 2 Normative references 3 Terms and definitions ..2 4 Degradation evaluation. .3 4.1 General. .3 4.2 Apparatus and reagents .4 4.3 Real-time degradation-Sample conditioning procedure. .5 4.3.1 Sampleloadingandplacement. .5 4.3.2 Control of temperature 5 4.3.3 .5 Controlofbuffersolution 4.3.4 Sample retrieval. .5 5 Physical, chemical and mechanical tests .6 5.1 General .6 5.2 Loss of sample mass. .6 5.2.1 Apparatus .6 5.2.2 Number oftestsamples .6 5.2.3 Procedure.. .7 5.2.4 Reusabilityoftest specimens. 5.3 Evaluation of molarmass. .8 5.3.1 Via inherent viscosity 5.3.2 Viagelpermeationchromatography/sizeexclusionchromatography .8 5.4 Mechanical tests. 5.4.1 General .8 5.4.2 Conditioning of test samples .8 5.4.3 Test methods 9 5.5 Additionalevaluationmethodsforconsideration. .9 6 Test termination .9 7 Test report .10 Annex A (informative) Nomenclature ofabsorb,degrade and related terms ..12 AnnexB (informative)Additionalanalyticmethodsforconsideration ..13 Bibliography ..14 iii See=ZHEJIANG INSTOFSTANDARDIZATIONC15956617 ithout license from IHS Not for Resale, 2017/9/27 05:33:26