BS ISO 11040-3:2012 BSl Standards Publication Prefilled syringes Part 3: Seals for dental local anaesthetic cartridges bsi. ..making excellence a habit BRITISH STANDARD BS ISO 11040-3:2012 National foreword This British Standard is the UK implementation of IS0 11040-3:2012. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @The British Standards Institution 2012.Published by BSI Standards Limited 2012 ISBN9780580706066 ICS 11.040.10; 11.040.25; 11.060.20 Compliance witha British Standard cannot confer immunity from legalobligations. This British Standard was published under the authority of the Amendments issued sincepublication Date Text affected BS ISO 11040-3:2012 INTERNATIONAL ISO STANDARD 11040-3 Second edition 2012-01-15 Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges Seringuespreremplies- Partie 3: Rondelles d'etancheite pour cartouches dentaires d'anesthésie locale Reference number ISO 11040-3:2012(E) @ISO2012 BS ISO 11040-3:2012 ISO11040-3:2012(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 ii @IsO2012-Allrightsreserved BS ISO 11040-3:2012 ISO 11040-3:2012(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO11040-3waspreparedbyTechnicalCommitteeISO/TC76,Transfusion,infusionandinjection,andblood processing equipmentformedicalandpharmaceuticaluse. This second editioncancelsand replaces thefirstedition (isO 11040-3:1993),which hasbeen technically revised. IsO 11040 consists of the following parts, under the general title Preflled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2:Plunger stoppers for dental local anaesthetic cartridges Part 3:Sealsfordentallocal anaesthetic cartridges Part 4:Glass barrels forinjectables and ready-to-use prefillable syringes Part 5:Plunger stoppersfor injectables Part6:Plasticsbarrelsfor injectables The following parts are under preparation: @ ISO 2012 - All rights reserved ili BS ISO 11040-3:2012 ISO11040-3:2012(E) Introduction Primary packaging components made of elastomeric materials are an integral partof medicinal products. Therefore, Principles of cGMP are described in ISO 15378 or in the GMP Guidelines published by the European Community andtheUnitedStatesofAmerica. iv @ISO2012-All rightsreserved BS ISO 11040-3:2012 INTERNATIONALSTANDARD ISO 11040-3:2012(E) Prefilled syringes - Part 3: Sealsfordentallocalanaestheticcartridges 1 Scope This part of isO 11040 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The