International ISO Standard IS0 5840-2 Second edition Cardiovascular implants Cardiac 2021-01 valve prostheses Part 2: AMENDMENT 1 2025-03 Surgically implanted heart valve substitutes AMENDMENT 1 Implantscardiovasculaires-Prothesesvalvulaires- Partie2:Prothesesvalvulaires implantees chirurgicalement AMENDEMENT1 Referencenumber IS05840-2:2021/Amd.1:2025(en) ISO2025 IS05840-2:2021/Amd.1:2025(en) COPYRIGHTPROTECTED DOCUMENT @IS02025 All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 CP 401 : Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Email:[email protected] Website: www.iso.org Published in Switzerland IS02025-All rights reserved ii IS05840-2:2021/Amd.1:2025(en) Foreword Iso (the International Organizationfor Standardization)is a worldwide federation of national standards bodies (Iso member bodies). The work of preparing International Standards is normally carried out through Iso technical committees.Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmentaland non-governmental,in liaison with Iso,alsotakepartin thework.Iso collaboratesclosely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the Iso/IEC Directives, Part 1. Inparticular,the different approval criteria neededfor the different types of IsO document should be noted. This document was drafted in accordance with the editorial rules of the ISo/IEC Directives, Part 2 (see www.iso.org/directives). Iso draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s).Iso takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, Iso had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information,which may be obtainedfrom thepatent database available at www.iso.org/patents.Iso shall not be held responsible for identifying any or all such patent rights. Any trade name used in this document is information given for the convenience of users and does not constituteanendorsement. For an explanation of the voluntary nature of standards, the meaning of Iso specific terms and expressions related to conformity assessment, as well as information about Iso's adherence to the World Trade Organization (WTO)principles inthe Technical Barriersto Trade (TBT),seewww.iso.org/iso/foreword.html This document was prepared by Technical CommitteeISo/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with theAgreementontechnical cooperation between ISOand CEN (Vienna Agreement). Alistofall parts intheISO5840 seriescanbefound ontheISOwebsite. Anyfeedback or questions on this document should be directed to the user's national standards body.A completelistingofthesebodiescanbefoundatwww.iso.org/members.html @IS02025-All rightsreserved ii