ISO INTERNATIONAL STANDARD 13926-2 Third edition 2017-11 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use Systemesdestylos-injecteurs- Partie 2:Bouchons-pistons pour stylos-injecteurs d usage medical Reference number IS0 13926-2:2017(E) [so @IS02017 IS013926-2:2017(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2017, Published in Switzerland 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 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 ii @ IS0 2017 - All rights reserved IS0 13926-2:2017(E) Contents Page Foreword iv Introduction. .V 1 Scope. 1 2 Normative references .1 3 Terms and definitions 1 4 Classification 1 5 Shapeand dimensions 2 6 Designation .3 7 Material. .3 .3 8 Requirements 8.1 General 3 8.2 Physical requirements. 3 8.2.1 Hardness 3 8.2.2 Freedomfromleakage 3 8.2.3 Initiating and sustainingforces 4 8.2.4 Resistance to ageing. 4 8.3 Chemical requirements. 4 8.4 Biological requirements Labelling. .4 9 Annex A (normative) Leakage test 5 Bibliography 7 IS0 2017 - All rights reserved iii
ISO 13926-2 2017 Pen systems Part 2 Plunger stoppers for pen-injectors for medical use