ISO INTERNATIONAL STANDARD 25424 Second edition 2018-10 AMENDMENT 1 2022-01 Sterilization of health care products Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 1 Sterilisation des produits de sante-Formaldehyde et vapeur a faible temperature- -Exigencespourledeveloppement,lavalidationet le controlede routine d'un procedé de stérilisation pour dispositifs medicaux AMENDEMENT1 Reference number IS0 25424:2018/Amd.1:2022(E) ISO @ISO2022 IS025424:2018/Amd.1:2022(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2022 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 CP401·Ch.deBlandonnet8 CH-1214 Vernier,Geneva Phone: +41 22 749 01 11 Email:[email protected] Website:www.iso.org Published in Switzerland ii @IS0 2022-All rights reserved IS025424:2018/Amd.1:2022(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 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,governmental and non-governmental, in liaison withIso,also takepart in thework. 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 neededfor the different types of Iso documents 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). Attention is drawn to thepossibility 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. Details of anypatent rights identifiedduringthedevelopment of the document will be in the Introduction and/or ontheIso listofpatent declarationsreceived (seewww.iso.org/patents) 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 in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html. This document was prepared by Technical Committee ISo/TC198, Sterilization of health care products, in collaboration with theEuropean Committeefor Standardization (CEN)Technical Committee CEN/ TC 204, Sterilization of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Any feedback or questions on this document should be directed to the user's national standards body. A complete listing of thesebodies can be found at www.iso.org/members.html. @IS0 2022-All rights reserved ii