International iso Standard ISO 5840-3 Second edition Cardiovascular implants Cardiac valve prostheses - 2021-01 Part 3: AMENDMENT 1 Heart valve substitutes implanted 2025-03 by transcatheter techniques AMENDMENT 1 Implantscardiovasculaires-Prothesesvalvulaires Partie 3: Valves cardiaques de substitution implantees par des techniquestranscathéter AMENDEMENT1 Referencenumber IS0 5840-3:2021/Amd.1:2025(en) @ ISO 2025 IS05840-3:2021/Amd.1:2025(en) COPYRIGHTPROTECTEDDOCUMENT 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 40i : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland @ IS0 2025 - All rights reserved ii IS05840-3:2021/Amd.1:2025(en) 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 IsOtechnicalcommittees.Each member body interested in a subjectfor which atechnical committee has been established has the right to be represented on that committee. International organizations,governmental and non-governmental, in liaison with Iso, also take part in the work. Iso collaborates closely 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. In particular,the different approval criteria needed for 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 thedate 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 thelatest information, which may be obtained from the patent database available at www.iso.org/patents.IsO shall notbe held responsiblefor identifying any or all such patentrights. Any trade name used in this document is information given for the convenience of users and does not constituteanendorsement. Foran explanation of thevoluntary natureof standards,themeaning ofIsO specifictermsand expressions related to conformity assessment, as well as information about Iso's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html This document was prepared byTechnical Committee ISo/TC15o, Implants for surgery,Subcommittee SC2 Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee for Standardization (CEN)Technical CommitteeCEN/TC285,Non-active surgical implants, inaccordancewith the Agreement ontechnical cooperation between ISO and CEN (Vienna Agreement). A list of all parts in the ISO 5840 series can be found on the ISO website. Any feedback or questions on this document should be directed to theuser's national standards body.A complete listing of these bodies can befound at www.iso.org/members.html. @IS0 2025 All rights reserved i