1、October 2014Translation by DIN-Sprachendienst.English price group 11No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.180.30; 55.020!%;jo“2247176www.din.deDDIN EN ISO 17351Packaging Braille on packaging for medicinal products (ISO 17351:2013);English version EN ISO 17351:2014,English translation of DIN EN ISO 17351:2014-10Verpackung Blindenschrift auf Arzneimittelverpackungen (ISO 17351:2013);Englische Fassung
3、EN ISO 17351:2014,Englische bersetzung von DIN EN ISO 17351:2014-10Emballage Braille sur les emballages destins aux mdicaments (ISO 17351:2013);Version anglaise EN ISO 17351:2014,Traduction anglaise de DIN EN ISO 17351:2014-10SupersedesDIN EN 15823:2010-11www.beuth.deIn case of doubt, the German-lan
4、guage original shall be considered authoritative.Document comprises 19 pages09.14 DIN EN ISO 17351:2014-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17351:2014) was originally prepared as European Standard EN 15823:2010 by Technical Committee CEN/TC 261 “Packag
5、ing” (Secretariat: AFNOR, France). After the publication of the European Standard, a decision was made to further develop the standard as the International Standard ISO 17351:2013 within ISO/TC 122 “Packaging” (Secretariat: JISC, Japan). Once the International Standard was published it seemed logica
6、l that ISO 17351:2013 should be adopted as a European Standard that replaces EN 15823:2010. It is preferable to maintain one uniform standard, as this will prevent the possible further development of two deviating standards. The standard was developed with the participation of German experts. The re
7、sponsible German body involved in its preparation was the DIN-Normenausschuss Verpackungswesen (DIN Standards Committee Packaging), Working Committee NA 115-01-03 AA Markierung. Amendments This standard differs from DIN EN 15823:2010-11 as follows: a) the form has been adapted to that of the ISO Sta
8、ndard, the technical content of which had been adopted, unchanged, from EN 15823; b) minor editorial changes have been made due to the adaption of the ISO Standard; c) the Bibliography has been updated. Previous editions DIN EN 15823: 2010-11 EN ISO 17351July 2014 ICS 55.020 Supersedes EN 15823:2010
9、English Version Packaging - Braille on packaging for medicinal products(ISO 17351:2013)Emballage - Braille sur les emballages destins aux mdicaments (ISO 17351:2013) Verpackung - Blindenschrift auf Arzneimittelverpackungen (ISO 17351:2013) This European Standard was approved by CEN on 10 July 2014.
10、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 a
11、pplication 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
12、 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,
13、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved
14、worldwide for CEN national Members. Ref. No. EN ISO 17351:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContentsPage Foreword . 3 Introduction . 4 1 Scope . 5 2 Terms and definitions 5 3 General
15、requirements for medicinal product packaging . 5 3.1 Product identification 5 3.2 Braille spacing convention . 6 3.3 Braille character sets . 6 4 Determination of Braille legibility . 6 4.1 Principles of Braille legibility compliance . 6 4.2 Braille cell dot height . 6 4.3 Altered Braille labelling
16、. 7 Annex A (normative) Methods of verification . 8 Annex B (informative) Braille characteristics and recommendations 9 Annex C (informative) Technology for the application of Braille to packaging for medicinal products 11 Annex D (informative) Guidance on Braille specifications and artwork generati
17、on . 14 Annex E (informative) Braille character sets. 16 Bibliography 17 2DIN EN ISO 17351:2014-10 EN ISO 17351:2014 (E) ForewordThe 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 o
18、ver 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 nati
19、onal 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 superse
20、des 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 Mac
21、edonia, 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 C
22、EN as EN ISO 17351:2014 without any modification. 3DIN EN ISO 17351:2014-10EN ISO 17351:2014 (E)IntroductionThis International Standard has been developed to meet various national and regional requirements for Braille on packaging for medicinal products, and technical constraints and user requiremen
23、ts, 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 15
24、823) 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 requ
25、ired, 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
26、standards may be created to complement this International Standard.4DIN EN ISO 17351:2014-10 EN ISO 17351:2014 (E) 1 ScopeThis International Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.NOTE The principles in this Interna
27、tional Standard can be applied in other sectors, as appropriate.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1Brailletactile reading and writing system composed of Braille cells2.2Braille cellseries of up to six raised dots set out in a domino
28、-type cell2.3burst-throughcracking, breaking, pin-holing of the coating or material surface, visible to the naked eye, caused by the process of embossing Braille2.4labellinginformation on the immediate or outer packaging2.5Marburg Medium spacing conventiondefined system of dimensions within and betw
29、een the Braille cellsNote 1 to entry: The Marburg Medium spacing convention for Braille 4is recommended in the European Commission Guidance 3for use for medicinal product labelling and is explained in B.3.2.6marketing authorization holderMAHnatural or legal person or entity responsible for placing t
30、he medicinal product on the market3 General requirements for medicinal product packaging3.1 Product identification3.1.1 Information in BrailleThe 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.5DIN EN
31、ISO 17351:2014-10EN ISO 17351:2014 (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) as amended by Directive 2004/27/EC.1NOTE 1 Guidance on the
32、information to be labelled in Braille is given in the European Commission Guidance.3NOTE 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 te
33、xt placementThe 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 printe
34、d text and graphics, where possible.3.2 Braille spacing conventionThe 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 setsThe MAH shall identify and s
35、pecify the Braille character set appropriate to the market in which the product is to be supplied; see Annex E.4 Determination of Braille legibility4.1 Principles of Braille legibility complianceThe Braille text shall enable Braille readers to identify the medicinal product.Compliance with the Brail
36、le 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 heightIn
37、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) manufacturers site shall be:a) for embossed materials the target Braille cell dot height shall be 0,
38、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
39、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 manufacturers processes. Cardboard is not an engineering material and considerations relating to Braille ce
40、ll dot formation contained within Annex C can be taken into account in order to achieve Braille cell dot height requirements.6DIN EN ISO 17351:2014-10 EN ISO 17351:2014 (E) NOTE 2 Burst-through can occur when the substrate or any surface coating fractures, causing damage to print and/or surface fini
41、sh. 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-
42、through.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 labellingBraille shall not be obs
43、cured 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.7DIN EN ISO 17351:2014-10EN ISO 17351:2014 (E)Annex A (normative) Methods of verificationA.1 Braille cell dot
44、height measurementThe 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
45、-force not less than 0,5 N) micrometer with an anvil that covers at least three Braille dots in a cell (see Reference5). 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
46、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 be 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
47、identification by Braille legibility testingIt 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 (see 4.2) cannot be verified then samples can be tested for Braille
48、legibility by organizations representing blind and partially sighted people or other suitable organizations.NOTE Testing should be carried out on an agreed protocol taking into account the following factors:a) the qualification and number of the blind Braille readers used in the test;b) separate tes
49、ting of embossed cartons and labels if it is necessary to test the two types of packaging;c) establishing the minimum Braille cell dot height that results in product identification.8DIN EN ISO 17351:2014-10 EN ISO 17351:2014 (E) Annex B (informative) Braille characteristics and recommendationsB.1 Braille character setsBraille character sets consist of letters, numbers, punctuation, symbols and special characters. Some parts of character sets are common between countries whereas
