ISO INTERNATIONAL STANDARD 11607-1 Second edition 2019-02 Packagingforterminallysterilized medicaldevices Part 1: Requirementsformaterials,sterile barriersystemsandpackagingsystems Emballagesdesdispositifsmedicauxsterilisesqustadeterminal- Partie1:Exigencesrelatives auxmateriaux,auxsystemesdebarriere sterile et aux systemes d'emballage Referencenumber IS011607-1:2019(E) @IS02019 ISO11607-1:2019(E) COPYRIGHTPROTECTEDDOCUMENT ISO2019 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 beloworIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 40i.Ch. de Blandonnet 8 CH-1214 Vernier,Geneva Phone:+41227490111 Fax:+41227490947 Email:[email protected] Website:www.iso.org Published in Switzeriand i @IS0 2019-All rights reserved IS011607-1:2019(E) Contents Page Foreword iv Introduction .V 1 Scope. 1 2 Normativereferences .1 3 Terms and definitions .1 4 Generalrequirements .6 4.1 Qualitysystems. 6 4.2 Riskmanagement 6 4.3 Sampling .6 4.4 Testmethods 6 4.5 Documentation .7 5 Materials,preformed sterilebarriersystems and sterilebarriersystems .7 5.1 Generalrequirements 7 5.2 Microbialbarrierproperties 10 5.3 Compatibilitywiththesterilizationprocess 11 5.4 Labellingsystem 11 5.5 Storage and transport of materials and preformed sterile barrier systems. 11 6 Design and development for packaging systems. .12 6.1 General 12 6.2 Design 12 7 Usabilityevaluationforasepticpresentation 13 8 Packaging system performance and stability .14 8.1 General .14 8.2 Packaging systemperformancetesting .14 8.3 Stabilitytesting 15 9 Packaging system validationandchanges 15 10 Inspectionimmediatelypriortoasepticpresentation .16 11 Informationtobeprovided 16 AnnexA(informative)Guidanceonmedicalpackaging .17 AnnexB(informative)Standardizedtestmethods,guidesandproceduresthatcanbeused todemonstrateconformitywiththerequirementsofthisdocument 20 AnnexC(normative)Testmethodforresistanceofimpermeablematerialstothepassageofair.31 AnnexD(informative)Environmentalaspects 32 AnnexE(informative)Draftguidanceonwaystodifferentiateasterilebarriersystemfrom protectivepackaging 33 Bibliography 38 IS02019-All rights reserved ii