ISO INTERNATIONAL STANDARD 11499 Third edition 2014-06-01 Dentistry Single-use cartridges for local anaesthetics Médecine bucco-dentaire - Cartouches a usage unique pour anesthesiqueslocaux Reference number ISO 11499:2014(E) SO International Organization for Standardization Zhejiang Institute of Standardization 5956617 IS02014 vided by IHS under itted without license from IHS IS0 11499:2014(E) COPYRIGHTPROTECTEDDOCUMENT @ IS0 2014 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 [email protected] Web www.iso.org Published in Switzerland Prganizationfor Standardization Not for Resale, 2015/3/11 02:08:38 networking permitted without license from IHS IS0 11499:2014(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references 3 Terms and definitions ..1 4 Requirements ..1 4.1 Freedom from leakage of anaesthetic solution .1 4.2 Force needed for plunger movement .2 4.3 Size of air bubble. 2 4.4 Biocompatibility .2 4.5 Extractable volume. 2 4.6 External dimensions of the assembled cartridge .2 4.7 Colour coding .2 5 Test methods. .4 5.1 Sampling. ..4 5.2 Test conditions 4 5.3 Visual inspection .4 5.4 Cartridge leakage 4 5.5 Force needed for plunger movement .5 5.6 Size of air bubble.. ..6 5.7 Extractable volume. .7 6 Marking .7 6.1 Primary container .7 6.2 Secondary container .7 Bibliography 9 iii see=Zhejiang Institute of Standardization 5956617 vithoutlicense from IHS