ISO INTERNATIONAL STANDARD 7198 Second edition 2016-08-01 Cardiovascular implants and extracorporeal systems Vascular prostheses Tubular vascular grafts and vascular patches Implantscardiovasculairesetsystemesextracorporels-Protheses vasculaires-Greffonsvasculaires tubulaires et piecesvasculaires Referencenumber IS0 7198:2016(E) ISO @IS02016 IS0 7198:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, 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 copyright office 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 @ IS0 2016 - All rights reserved IS0 7198:2016(E) Contents Page Foreword V Introduction. ..vi 1 Scope. .1 2 Normativereferences .2 3 Terms and definitions .2 4 General requirements 6 4.1 Configuration designationfortubularvasculargrafts 6 4.2 Size designation 7 4.2.1 Uniformstraighttubularvasculargrafts 4.2.2 Uniformbifurcatedtubularvasculargrafts 7 4.2.3 Tapered tubular vascular grafts. 7 4.2.4 Otherconfigurationsoftubularvasculargrafts 7 4.2.5 Vascularpatches. 7 4.3 7 Materials 7 4.3.1 General 4.3.2 Classificationoftubularvasculargraftsandvascularpatches 7 4.3.3 Nomenclature .8 4.4 Intended clinical use designation 8 5 Intended performance 9 6 Design attributes. 9 6.1 General. 9 6.2 Tubular vascular grafts 9 6.3 Vascularpatches 9 6.4 Coatings 10 6.5 Drug coatings and drug-eluting coatings 10 7 Materials .10 8 Design evaluation .10 8.1 General. 10 8.2 Sampling.. 11 8.3 Conditioningoftestsamples 11 8.4 Reporting 11 Biocompatibility 8.5 .12 8.5.1 Residual chemicals 12 8.5.2 Biocompatibility. 12 8.6 Biostability. 12 8.7 Bench and analytical tests 13 8.7.1 General 13 8.7.2 Tubular vascular grafts 13 8.7.3 Vascular patches. 15 9 Preclinical invivoevaluationtestmethodsforvascularprostheses .16 9.1 Preclinical invivoevaluation 16 9.1.1 Purpose. 16 9.1.2 Specificaims 17 9.1.3 Protocol considerations 17 9.1.4 Data acquisition 17 9.1.5 Test report and additional information 18 10 Clinical investigation methods forvascularprostheses .19 10.1 Clinical investigation. 19 10.1.1 19 Purpose 10.1.2 Specific aims 19 216l rightsreserved ii