SIST 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.
Verpackung - Blindenschrift auf Arzneimittel-Verpackungen
Diese Europäische Norm legt Anforderungen fest und stellt Anleitungen bereit für die Aufbringung der
Blindenschrift zur Kennzeichnung von Arzneimitteln.
ANMERKUNG 1 Die Kennzeichnung von inverkehrgebrachten Arzneimitteln und die Aufbringung der Blindenschrift in
Übereinstimmung mit dieser Europäischen Norm erfüllen die Anforderungen der Europäischen Richtlinie 2001/83/EG
Artikel 56 (a) in der von der Richtlinie 2004/27/EG [1] ergänzten Form.
ANMERKUNG 2 Die allgemeinen Anforderungen dieser Europäischen Norm können in anderen Bereichen, wenn
zutreffend, angewendet werden.
Emballage - Csur 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 les 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 généraux 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 . 18 SIST EN 15823:2010
EN 15823:2010 (E) 3 Foreword This document (EN 15823:2010) has been prepared 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 December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. 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. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. SIST EN 15823:2010
EN 15823:2010 (E) 4 Introduction Council Directive 2004/27/EC [1] modifies the Community Legislation for medicinal products for human use (Directive 2001/83/EC [2]) and by subsequent incorporation into national legislation, introduces the need to include on the packaging of authorized medicinal products their names and, where appropriate, the form and strength in Braille as an aid to identification for blind and partially sighted people. This European Standard is primarily aimed at supporting the implementation of Braille on medicinal products in the European Union (EU) and European Economic Area (EEA) and in particular, Chapter 2 of the associated European Commission Braille Implementation Guidelines [3]. SIST EN 15823:2010
EN 15823:2010 (E) 5 1 Scope 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. 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 NOTE The Marburg Medium spacing convention for Braille [4] is recommended in the European Commission Guidance [3] for use for medicinal product labelling. 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 as required in the country in which the product is to be supplied. NOTE 1 Guidance on the information to be labelled in Braille is given in the European Commission Guidance [3]. SIST EN 15823:2010
EN 15823:2010 (E) 6 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. 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 name of 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 should be taken into account in order to achieve Braille cell dot height requirements. NOTE 2 Burst-through can occur when the substrate or any surface coating fractures causing damage to print and/or surface finish. Burst-through is not recommended, but might be accepted by certain markets, however the presence of burst-through should not in itself constitute a valid reason for batch rejection. NOTE 3 Braille dots should not compromise any printed text whether the dots are intact or are formed with a burst-through. SIST EN 15823:2010
EN 15823:2010 (E) 7 NOTE 4 The Braille cell dot height limits included above reflect technical issues associated with the production of pharmaceutical packaging – they do not necessarily represent a Braille cell dot height that can be achieved with other media. 4.3 Altered Braille labelling Braille shall not be obscured by labels or any other adhesive devices, with only one exception: where Braille needs to be altered, the new Braille text should cause the original Braille text to be totally obscured. SIST EN 15823:2010
EN 15823:2010 (E) 8 Annex A (normative)
Methods of verification A.1 Braille cell dot height measurement The number of samples and the method of measurement shall be agreed between the customer and supplier. The Braille cell dot height shall be measured along the Braille text in at least three places.
The Braille cell dot height can be measured using a calibrated, spring-loaded (spring-force not less than 0,5 N) micrometer with an anvil that covers at least three Braille dots in a cell, see [5]. Measurement of the Braille cell dot height shall use cells containing at least three dots. Alternative methods may be used provided that they are of at least equivalent precision and accuracy.
Measurements can be performed with two decimal places and results shall be reported to two decimal places. NOTE It is recommended that random checks are carried out across all stations, see C.5.2. Checks should also be made to ensure the readability of underlying printed text.
A.2 Product identification by Braille legibility testing It is not necessary to undertake legibility testing for each batch provided that the Braille specification applied has been adequately validated.
If the Braille cell dot height requirement (
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