ISO 17351:2013

Packaging — Braille on packaging for medicinal products

ISO 17351:2013 specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

Emballage — Braille sur les emballages destinés aux médicaments

L'ISO 17351:2013 spécifie les exigences et fournit les lignes directrices relatives à l'application du braille sur l'étiquetage des médicaments.

General Information

• Status: Published
• Publication Date: 08-Jan-2013
• ICS: 55.020 - Packaging and distribution of goods in general
• Technical Committee: ISO/TC 122 - Packaging
• Drafting Committee: ISO/TC 122 - Packaging
• Current Stage: 9060 - Close of review
• Start Date: 04-Mar-2029

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 17351
First edition
2013-01-15
Packaging — Braille on packaging for
medicinal products
Emballage — Braille sur les emballages destinés aux médicaments
Reference number
ISO 17351:2013(E)
©
ISO 2013

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ISO 17351:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 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
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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

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ISO 17351:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 General requirements for medicinal product packaging . 1
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 . 5
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
© ISO 2013 – All rights reserved iii

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ISO 17351:2013(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 technical committees. Each member body interested in a subject for which a technical
committee has b
...

DRAFT INTERNATIONAL STANDARD ISO/DIS 17351
ISO/TC 122 Secretariat: JISC
Voting begins on Voting terminates on

2011-11-29 2012-04-29
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION


Packaging — Braille on packaging for medicinal products
Emballage — Braille sur les emballages destinés aux produits médicaux
ICS 55.020










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Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
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Secrétariat central de l'ISO au stade de publication.



THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
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©  International Organization for Standardization, 2011

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ISO/DIS 17351

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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 [e-mail]
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

ii © ISO 2011 – All rights reserved

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ISO/DIS 17351
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Terms and definitions . 1
3 General requirements for medicinal product packaging . 2
3.1 Product identification . 2
3.1.1 Information in Braille . 2
3.1.2 Braille text placement . 2
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 .
...

NORME ISO
INTERNATIONALE 17351
Première édition
2013-01-15
Emballage — Braille sur les
emballages destinés aux médicaments
Packaging — Braille on packaging for medicinal products
Numéro de référence
ISO 17351:2013(F)
©
ISO 2013

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ISO 17351:2013(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2013
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Version française parue en 2014
Publié en Suisse
ii © ISO 2013 – Tous droits réservés

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ISO 17351:2013(F)

Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Termes et définitions . 1
3 Exigences générales relatives à l’emballage des médicaments . 1
3.1 Identification du produit . 1
3.2 Convention d’espacement de braille . 2
3.3 Jeux de caractères braille . 2
4 Détermination de la lisibilité du texte en braille . 2
4.1 Principes de conformité de la lisibilité du texte en braille . 2
4.2 Hauteur de point de la cellule braille. 2
4.3 Étiquetage braille modifié . 3
Annexe A (normative) Méthodes de vérification . 4
Annexe B (informative) Caractéristiques et recommandations relatives au braille .5
Annexe C (informative) Technologie relative à l’application du braille sur l’emballage
des médicaments . 7
Annexe D (informative) Spécifications relatives au braille et à la génération des illustrations .11
Annexe E (informative) Jeux de caractères braille .13
Bibliographie .14
© ISO 2013 – Tous droits réservés iii

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ISO 17351:2013(F)

Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité
...