ISO INTERNATIONAL STANDARD 17351 First edition 2013-01-15 Packaging Braille on packaging for medicinal products Emballage - Braille sur les emballages destinés aux médicaments Reference number IS0 17351:2013(E) LSO IS02013 IHS under ted without license from IHS Not for Resale IS0 17351:2013(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2013 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 addressbeloworIso'smemberbodyinthecountryoftherequester. ISO copyright office Case postale 56:CH-1211 Geneva 20 Tel.+41227490111 Fax + 4122 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ IS0 2013 - All rights reserved networkingpemittedwithoutlicensefromIHS Not for Resale IS0 17351:2013(E) Contents Page Foreword .iv Introduction. ..V 1 Scope. .1 2 Terms and definitions ..1 3 General requirements for medicinal product packaging 3.1 Product identification .1 3.2 Braille spacing convention .2 3.3 Braille character sets .2 4 Determination of Braille legibility .2 4.1 Principles of Braille legibility compliance .2 4.2 Braille cell dot height. 2 4.3 Altered Braille labelling 3 Annex A (normative) Methods of verification ..4 Annex B (informative) Braille characteristics and recommendations Annex C (informative) Technology for the application of Braille to packaging for medicinal products .7 Annex D (informative) Guidance on Braille specifications and artwork generation ..10 Annex E (informative) Braille character sets. .12 Bibliography .13 iii Stal se with I ut license from IHS Not for Resalel