ISO INTERNATIONAL STANDARD 11658 First edition 2012-05-15 Cardiovascular implants and extracorporeal systems Blood/ tissue contact surface modifications for extracorporeal perfusion systems Implants cardiovasculaires et systemes extracorporels Revetements pour I'équipement au contact du sang Reference number ISO 11658:2012(E) ISO @ISO2012 HS under I Not for Resale ISO 11658:2012(E) COPYRiGHTPROTECTEDDOCUMENT ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing 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 [email protected] Web www.iso.org Published in Switzerland @ ISO 2012 - All rights reserved No reproduction or networking permtted without license from IHS Not for Resale ISO 11658:2012(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/lEc Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 11658 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems ii Not for Resale