ISO INTERNATIONAL STANDARD 13926-3 Second edition 2019-05 Pen systems - Part 3: Seals for pen-injectors for medical use Systemes de stylos-injecteurs Partie 3: Joints pour stylos-injecteurs a usage medical Reference number ISO 13926-3:2019(E) Tso @IS02019 IS0 13926-3:2019(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2019 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: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: copyright@iso.org Website: www.iso.org Published in Switzerland ii @ IS0 2019 - All rights reserved IS0 13926-3:2019(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions 4 Classification ..2 5 Shape and dimensions ..2 6 Designation ..3 7 Material .3 7.1 Cap. ..3 7.2 Disc. .3 8 Requirements .3 8.1 General .3 8.2 Physical requirements .3 8.2.1 Hardness of the disc 3 8.2.2 Fragmentation. .4 8.2.3 Freedom from leakage .4 8.2.4 Resealability 8.2.5 Resistance to ageing. 4 8.3 Chemical requirements. ..4 8.4 Biological requirements .4 9 Labelling. .4 Annex A (normative) Leakage test ..5 Bibliography .7 IS0 2019 - All rights reserved iii