ISO INTERNATIONAL STANDARD 11040-5 Third edition 2012-01-15 Prefilled syringes - Part 5: Plunger stoppers for injectables Seringuespréremplies- Partie 5: Bouchons-pistons pour produits injectables Reference number ISO 11040-5:2012(E) ISO @ IS0 2012 ISO 11040-5:2012(E) COPYRIGHTPROTECTEDDOCUMENT ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 · CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ISO2012-All rights reserved ISO11040-5:2012(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO technicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeen non-governmental, in liaison with isO, also take part in the work. isO collaborates closely with the International International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards International Standard requires approval by at least 75 % of the member bodies casting a vote. rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 11040-5 was prepared by Technical Committee ISO/Tc 76, Transfusion, infusion and injection, and blood processing equipment formedicalandpharmaceuticaluse. revised by: adjusting the title of this part of iSO 11040; aligning this International Standard with the ISO 8871 series; revising the requirements on the height of the spacers and requirements on material and hardness; adding requirements on resistance to ageing. ISO 11040 consists of the following parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridges Part 4: Glass barrels for injectables and ready-to-use prefillable syringes Part 5: Plunger stoppers for injectables Part 6: Plastics barrels for injectables The following parts are under preparation: Part 7:Packaging systems for prefillable ready-to-use syringes -/riahts reserved ili