ISO INTERNATIONAL STANDARD 11040-7 Firstedition 2015-04-01 Prefilled syringes Part 7: Packaging systems for sterilized subassembled syringes ready for filling Seringues préremplies - Partie 7: Systemes d'emballage pour les seringues stérilisées pretes a I'emploi préremplissables Reference number ISO 11040-7:2015(E) SO International Organization for Standardization @ IS0 2015 ted without license from IHS IS0 11040-7:2015(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2015 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 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 Case postale 56:CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland Prganizationfor Standardization Not for Resale, 2015/6/29 08:34:32 networking permitted without license from IHS IS0 11040-7:2015(E) Contents Page Foreword ..iv Introduction ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions ..1 4 Requirements for the packaging system 4.1 General .2 4.2 Nest. .3 4.3 Tub. 4 4.4 Insert liner .4 4.5 Sealing lid 4 4.6 Protective bag ..5 5 Information to be provided by the manufacturer ..5 6 Marking of the tub ..5 7 Packaging of tubs in trading units/bundles. ..6 Annex A (informative) Design of nests .7 Annex B (informative) Determination of nest deflection ..14 Annex C (informative) Design of tubs ..17 Annex D (informative) Schematic illustrations of examples for the orientation of tubs within the protective bag. .19 Annex E (informative) Design and dimensions of the protective bag ..21 Annex F (informative) Test method to determine the distance between the edge of the protective bag to the rear end of the tub. .24 Bibliography .27 iii andardization5956617 lout license from IHS