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 Stérilisation desproduitsdesantéFormaldéhydeetvapeurafaible température - Exigences pour le développement, la validation et le controle de routine d'un procédé de stérilisation pour dispositifs médicaux AMENDEMENT1 Reference number IS0 25424:2018/Amd.1:2022(E) ISO @ ISO 2022 IS0 25424:2018/Amd.1:2022(E) COPYRIGHT PROTECTED DOCUMENT @IS02022 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: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2022 - All rights reserved