ISO INTERNATIONAL STANDARD 8362-5 Third edition 2016-02-15 Injection containers and accessories - Part 5: Freeze drying closures for injection vials Récipients et accessoires pour produits injectables Partie 5: Bouchons a lyophilisation pour flacons d'injection Reference number IS0 8362-5:2016(E) ISO International Organization for Standardization @ IS0 2016 vided by IHS underI ed without license from IHS IS0 8362-5:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS02016,PublishedinSwitzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org Intenatinair PrganizationforStandardization ensee-ZHEJIANG INSTOF STANDARDIzARoISQ16- All rights reserved Not for Resale, 2016/4/26 02:05:03 etworking permitted without license from IHS IS0 8362-5:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope.. ..1 2 Normative references 3 Terms and definitions 4 Shape and dimensions. ..2 5 Designation. ..4 6 Material. ..4 7 Performance requirements ..4 7.1 General ..4 7.2 Physical requirements 7.2.1 Hardness .4 7.2.2 Penetrability 4 7.2.3 Fragmentation. 4 7.2.4 Self-sealing and aqueous solution tightness .5 7.2.5 .5 7.2.6 Resistance to ageing. .5 7.2.7 Residual moisture 5 7.3 Chemical requirements. .5 7.4 Biological requirements. .5 7.5 Particulate contamination requirements ..5 8 Labelling ..5 Annex A (informative) Determination of moisture 6 Bibliography 9 iii ee=ZHEJIANG INST OF STANDARDIZATION C15956617 vided by IHS under lic ithout license from IHS Not for Resale, 2016/4/26 02:05:03