ISO INTERNATIONAL STANDARD 8871-5 Second edition 2016-10-15 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing Elements en élastomere pour administration parenterale et dispositifs a usage pharmaceutique - Partie 5: Exigences fonctionnelles et essais Reference number IS0 8871-5:2016(E) Tso @IS02016 IS0 8871-5:2016(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2016, Published in Switzerland All rights reserved. Unless otherwise specified, 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 the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel.+4122749 0111 Fax +41 22 749 09 47 [email protected] www.iso.org ii IS02016-Allrightsreserved IS0 8871-5:2016(E) @ Contents Page Foreword .iv Introduction ..V 1 Scope. 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements .2 4.1 Penetrability 2 4.2 Fragmentation 2 4.3 Self-sealing and aqueous solution tightness 2 4.4 Aqueous solution tightness. .2 5 Preparation of elastomeric closures for testing .2 5.1 Sampling. 2 5.2 Cleaning. .2 5.3 Sterilization .2 Annex A (normative) Test for penetrability ..3 Annex B (normative) Test for fragmentation .4 Annex C (normative) Test for self-sealing and dye solution tightness ..6 Annex D (normative) Test for dye solution tightness. .8 Bibliography .10 @ IS0 2016 - All rights reserved iii