ISO INTERNATIONAL STANDARD 11607-1 Second edition 2019-02 AMENDMENT 1 2023-09 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management Emballages des dispositifs medicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systemes de barriere sterile et aux systemes d'emballage AMENDEMENT1:Applicationdelagestiondesrisques Reference number IS0 11607-1:2019/Amd.1:2023(E) os1 @ IS0 2023 IS0 11607-1:2019/Amd.1:2023(E) COPYRIGHT PROTECTED DOCUMENT @IS02023 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 2023 - All rights reserved