SIST EN ISO 17351:2014

SLOVENSKI STANDARD
SIST EN ISO 17351:2014
01-oktober-2014
1DGRPHãþD
SIST EN 15823:2010
Embalaža - Braillova pisava na embalaži za zdravila (ISO 17351:2013)
Packaging - Braille on packaging for medicinal products (ISO 17351:2013)
Verpackung - Blindenschrift auf Arzneimittelverpackungen (ISO 17351:2013)
Emballage - Braille sur les emballages destinés aux médicaments (ISO 17351:2013)
Ta slovenski standard je istoveten z: EN ISO 17351:2014
ICS:
11.180.30 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptations for
EUDQMH reading
55.020 Pakiranje in distribucija blaga Packaging and distribution of
na splošno goods in general
SIST EN ISO 17351:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17351:2014

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SIST EN ISO 17351:2014

EUROPEAN STANDARD
EN ISO 17351

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2014
ICS 55.020 Supersedes EN 15823:2010
English Version
Packaging - Braille on packaging for medicinal products (ISO
17351:2013)
Emballage - Braille sur les emballages destinés aux Verpackung - Blindenschrift auf Arzneimittelverpackungen
médicaments (ISO 17351:2013) (ISO 17351:2013)
This European Standard was approved by CEN on 10 July 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17351:2014 E
worldwide for CEN national Members.

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SIST EN ISO 17351:2014
EN ISO 17351:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 17351:2014
EN ISO 17351:2014 (E)
Foreword
The text of ISO 17351:2013 has been prepared by Technical Committee ISO/TC 122 “Packaging” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 17351:2014 by
Technical Committee CEN/TC 261 “Packaging” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by January 2015, and conflicting national standards shall be withdrawn at
the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 15823:2010.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 17351:2013 has been approved by CEN as EN ISO 17351:2014 without any modification.

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SIST EN ISO 17351:2014

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SIST EN ISO 17351:2014
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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SIST EN ISO 17351:2014
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 copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

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SIST EN ISO 17351:2014
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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SIST EN ISO 17351:2014
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 been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an 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.
ISO 17351 was prepared by Technical Committee ISO/TC 122, Packaging.
iv © ISO 2013 – All rights reserved

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SIST EN ISO 17351:2014
ISO 17351:2013(E)

Introduction
This International Standard has been developed to meet various national and regional requirements
for Braille on packaging for medicinal products, and technical constraints and user requirements, to
harmonize technical standardization and specifications. The knowledge and experience that has been
gained in EN 15823:2010 was used for the development of this International Standard.
The background for the creation of an European Standard for Braille on packaging for medicinal products
(EN 15823) was a European Directive issued in 2004 by the European Commission (Council Directive
2004/27/EC). This Directive requires Braille labelling on outer packaging for medicinal products within
the European Union. In practice it means that basically the name of the medicinal product and, where
required, the form and strength has to be in Braille as an aid to identification for blind and partially
sighted people.
Braille will continue to be an essential means of communication for blind and visually impaired people
around the world. Once other accessible packaging technologies emerge additional standards may be
created to complement this International Standard.
© ISO 2013 – All rights reserved v

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SIST EN ISO 17351:2014

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SIST EN ISO 17351:2014
INTERNATIONAL STANDARD ISO 17351:2013(E)
Packaging — Braille on packaging for medicinal products
1 Scope
This International Standard specifies requirements and provides guidance for the application of Braille
to the labelling of medicinal products.
NOTE The principles in this International Standard can be applied in other sectors, as appropriate.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
Braille
tactile reading and writing system composed of Braille cells
2.2
Braille cell
series of up to six raised dots set out in a domino-type cell
2.3
burst-through
cracking, breaking, pin-holing of the coating or material surface, visible to the naked eye, caused by the
process of embossing Braille
2.4
labelling
information on the immediate or outer packaging
2.5
Marburg Medium spacing convention
defined system of dimensions within and between the Braille cells
[4]
Note 1 to entry: The Marburg Medium spacing convention for Braille is recommended in the European
[3]
Commission Guidance for use for medicinal product labelling and is explained in B.3.
2.6
marketing authorization holder
MAH
natural or legal person or entity responsible for placing the medicinal product on the market
3 General requirements for medicinal product packaging
3.1 Product identification
3.1.1 Information in Braille
The approved Braille text on the labelling shall include the information in Braille as required in the
country in which the product is to be supplied.
© ISO 2013 – All rights reserved 1

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SIST EN ISO 17351:2014
ISO 17351:2013(E)

The labelling of medicinal products placed on the market and incorporating Braille in accordance with
this International Standard meets the requirements of European Directive 2001/83/EC, Article 56, (a)
[1]
as amended by Directive 2004/27/EC.
[3]
NOTE 1 Guidance on the information to be labelled in Braille is given in the European Commission Guidance.
NOTE 2 It might be necessary to include Braille text on more than one panel in order to accommodate the
legally required information ensuring that Braille cell dots do not compromise any printed text.
3.1.2 Braille text placement
The placement of Braille text shall not reduce the legibility of printed text for sighted people (see
also Annex D).
NOTE 1 This is indicated when, for example, the application of Braille corrupts printed text and graphics.
NOTE 2 The MAH is encouraged to place the Braille away from printed text and graphics, where possible.
3.2 Braille spacing convention
The MAH shall specify the Braille spacing convention to be used. The use of Marburg Medium spacing
convention is highly recommended unless there is a specific national requirement.
3.3 Braille character sets
The MAH shall identify and specify the Braille character set appropriate to the market in which the
product is to be supplied; see Annex E.
4 Determination of Braille legibility
4.1 Principles of Braille legibility compliance
The Braille text shall enable Braille readers to identify the medicinal product.
Compliance with the Braille cell dot height limits (see 4.2) is evidence of compliance with the text
legibility requirement.
If the MAH does not specify compliance with the Braille cell dot height requirements (see 4.2 and A.1)
then legibility testing shall be carried out in accordance with A.2.
4.2 Braille cell dot height
In order to ensure that Braille readers can identify the medicinal product, the Braille cell dot height
of production samples when measured in accordance with A.1 at the packaging (e.g. carton or label)
manufacturer’s site shall be:
a) for embossed materials the target Braille cell dot height shall be 0,20 mm with not more than 5 % of
Braille cell dot height measurements lower than 0,12 mm and not more than 1 % of Braille cell dot
height measurements lower than 0,10 mm;
b) for other Braille production methods, e.g. screen-printed labels, the target Braille cell dot height shall
be 0,20 mm, with not more than 5 % of Braille cell dot height measurements lower than 0,16 mm.
NOTE 1 The MAH and packaging manufacturer are encouraged to aim for a higher cell dot height in line with
the packaging manufacturer’s processes. Cardboard is not an engineering material and considerations relating to
Braille cell dot formation contained within Annex C can be taken into account in order to achieve Braille cell dot
height requirements.
2 © ISO 2013 – All rights reserved

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SIST EN ISO 17351:2014
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