ISO INTERNATIONAL STANDARD 25539-1 Second edition 2017-02 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Protheses endovasculaires Reference number ISO 25539-1:2017(E) rso International Organization for Standardization @ IS0 2017 ZHEJIANG INST OF STANDARDIZATION C1 5956617 vided by IHS under ted without license from IHS IS0 25539-1:2017(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2017, Published in Switzerland 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 copyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Intenationaibr PrganizationforStandardization ensee-ZHEJIANG INST OF STANDARDIZRoISQ $17 - All rights reserved etworking permitted without license from IHS IS0 25539-1:2017(E) Contents Page Foreword ..V Introduction. ...vi 1 Scope. 2 Normative references 3 Terms and definitions 4 General requirements for endovascular system 4.1 Type of endovascular prosthesis .4 4.2 Materials and construction for endovascular system ..4 4.3 Configuration and size designation for endovascular prosthesis ..5 4.4 Intended clinical usefor endovascular system. 4.5 Balloon designation. .6 5 Intended performance ..6 6 Design attributes. .6 6.1 General. 6.2 Endovascular system ..6 6.3 Endovascular prosthesis ..6 6.4 Endovascular system and endovascular prosthesis > 7 Materials > 8 Design evaluation .7 8.1 General 8.2 Sampling. .8 8.3 Conditioning of test samples. .9 8.4 Reporting .9 8.5 Bench and analytical tests .10 8.5.1 Endovascular system and delivery system .10 8.5.2 Endovascular prosthesis .12 8.6 Preclinical in vivo evaluation. .18 8.6.1 Purpose. .18 8.6.2 Specificaims .18 8.6.3 Protocol considerations. .19 8.6.4 Data acquisition. 19 8.6.5 Test report and additional information .21 8.7 Clinical evaluation. 21 8.7.1 Purpose 21 8.7.2 Specificaims 22 8.7.3 Protocol considerations 22 8.7.4 Data acquisition. 23 8.7.5 Final report. ..26 9 Post-market surveillance ..27 10 Manufacturing. ..27 11 Sterilization .27 11.1 Products supplied sterile 27 11.2 Sterilization residuals 27 12 Packaging 28 12.1 Protection from damage in storage and transport. 28 12.1.1 General. 28 12.1.2 Unit container. .28 12.1.3 Outer container. .28 12.1.4 Shipping container. .28 iii ISee=ZHEJIANG INST OF STANDARDIZATION C1 5956617 withoutlicense from IHS