EN 15823:2010
(Main)Packaging - Braille on packaging for medicinal products
Packaging - Braille on packaging for medicinal products
This European Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.
NOTE 1 The labelling of medicinal products placed on the market and incorporating Braille in accordance with this European Standard meets the requirements of European Directive 2001/83/EC, Article 56, (a) as amended by Directive 2004/27/EC [1].
NOTE 2 The principles in this European Standard can be applied in other sectors, as appropriate.
Verpackung - Blindenschrift auf Arzneimittelverpackungen
Diese Europäische Norm legt Anforderungen fest und stellt Anleitungen bereit für die Aufbringung der Blindenschrift zur Kennzeichnung von Arzneimitteln.
ANMERKUNG 1 Die Kennzeichnung von in den Verkehr gebrachten Arzneimitteln und die Aufbringung der Blinden-
schrift in Übereinstimmung mit dieser Europäischen Norm erfüllen die Anforderungen der Europäischen Richt-
linie 2001/83/EG Artikel 56 (a) in der von der Richtlinie 2004/27/EG [1] geänderten Form.
ANMERKUNG 2 Die Anforderungen dieser Europäischen Norm können in anderen Bereichen, wenn zutreffend, angewendet werden.
Emballage - Braille sur les emballages destinés aux médicaments
La présente Norme européenne spécifie les exigences et fournit les lignes directrices relatives à l’application du braille sur l’étiquetage des médicaments. NOTE 1 L’étiquetage des médicaments placés sur le marché et incorporant du braille, conformément à la présente Norme européenne, satisfait aux exigences de l’Article 56 (a) de la Directive européenne 2001/83/CE amendée par la Directive 2004/27/CE [1]. NOTE 2 Les principes de la présente Norme européenne peuvent s’appliquer à d’autres secteurs, selon le cas.
Embalaža - Braillova pisava na embalaži za zdravila
Ta evropski standard določa zahteve in podaja navodilo za uporabo Braillove pisave za etiketiranje zdravil.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Embalaža - Braillova pisava na embalaži za zdravilaVerpackung - Blindenschrift auf Arzneimittel-VerpackungenEmballage - Csur les emballages destinés aux médicamentsPackaging - Braille on packaging for medicinal products55.020Pakiranje in distribucija blaga na splošnoPackaging and distribution of goods in general11.180.30EUDQMHAids and adaptations for readingICS:Ta slovenski standard je istoveten z:EN 15823:2010SIST EN 15823:2010en,fr,de01-november-2010SIST EN 15823:2010SLOVENSKI
STANDARD
SIST EN 15823:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15823
June 2010 ICS 11.120.99; 11.180.30 English Version
Packaging - Braille on packaging for medicinal products
Emballage - Braille sur les emballages destinés aux médicaments
Verpackung - Blindenschrift auf ArzneimittelverpackungenThis European Standard was approved by CEN on 26 May 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15823:2010: ESIST EN 15823:2010
EN 15823:2010 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Terms and definitions .53General requirements for medicinal product packaging .53.1Product identification .53.2Braille spacing convention .63.3Braille character sets .64Determination of Braille legibility .64.1Principles of Braille legibility compliance .64.2Braille cell dot height .64.3Altered Braille labelling .7Annex A (normative)
Methods of verification .8Annex B (informative)
Braille characteristics and recommendations .9Annex C (informative)
Technology for the application of Braille to packaging for medicinal products . 11Annex D (informative)
Guidance on Braille specifications and artwork generation . 15Annex E (informative)
Braille character sets . 17Bibliography .
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