ISO INTERNATIONAL STANDARD 16408 Second edition 2015-08-15 Dentistry Oral care products Oral rinses Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche Reference number IS0 16408:2015(E) ISO International Organization for Standardization =Zhejiang Institute of Standardization 5956617 IS02015 Not for Resale, 2015/11/11 07:04:19 No reproduction or networking permitted without license from IHS IS0 16408:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2015, Published in Switzerland 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. ISO copyrightoffice 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 Intenatinair PrganizationforStandardization etworking permitted without license from IHS IS0 16408:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. ..1 2 Normative references ..1 3 Terms and definitions 4 Classification ..2 5 Requirements .2 5.1 pH value .2 5.2 Total fluoride concentration and maximum amount of fluoride 2 5.3 Unintended heavy metals .2 5.4 Compatibility with oral tissues .2 5.5 Microbial contamination 2 5.6 Stability against ageing .3 5.7 Container and/or dispensing system 3 5.8 Readilyfermentablecarbohydrates. 3 Sampling. 6 .3 7 Test methods. .3 7.1 General .3 7.2 Visual inspection .3 7.3 Determination of pH value. .3 7.4 Determination of stability against ageing .3 7.4.1 Test. .3 7.4.2 Compliance 4 7.5 Pass/fail criteria .4 8 Test report ..4 9 Accompanying information ..4 9.1 Manufacturer's instructions for use .4 9.2 Information on the primary container, and on the secondary container, if it exists. ..4 10 Packaging ..5 Annex A (normative) Determination of fluoride in oral rinses containing ionic fluoride compounds .6 Bibliography 9 iii vided by IHS under ithout license from IHS