1、BSI Standards PublicationBS EN ISO 17351:2014Packaging Braille onpackaging for medicinalproducts (ISO 17351:2013)BS EN ISO 17351:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17351:2014. It is identical to ISO 17351:2013. It supersedes BS EN15823:2010
2、which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PKW/0/-/5, Packaging - Product Identification (Braille).A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the
3、 necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 76663 3ICS 11.120.99; 11.180.30; 55.020Compliance with a British Standard cannot confer immunity fromlegal obligations.Th
4、is British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17351 July 2014 ICS 55.020 Supersedes EN 15823:2010English Version Pack
5、aging - 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. CEN members are bo
6、und 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
7、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
8、 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,
9、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000
10、Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17351:2014 EBS EN ISO 17351:2014EN ISO 17351:2014 (E) 3 Foreword The text of ISO 17351:2013 has been prepared by Technical Committee ISO/TC 122 “Packaging” of the In
11、ternational 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
12、 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 responsib
13、le 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, Cze
14、ch 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 Kingdo
15、m. Endorsement notice The text of ISO 17351:2013 has been approved by CEN as EN ISO 17351:2014 without any modification. BS EN ISO 17351:2014ISO 17351:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 General requirements for medici
16、nal product packaging . 13.1 Product identification . 13.2 Braille spacing convention 23.3 Braille character sets . 24 Determination of Braille legibility . 24.1 Principles of Braille legibility compliance . 24.2 Braille cell dot height . 24.3 Altered Braille labelling . 3Annex A (normative) Methods
17、 of verification. 4Annex B (informative) Braille characteristics and recommendations . 5Annex C (informative) Technology for the application of Braille to packaging for medicinal products 7Annex D (informative) Guidance on Braille specifications and artwork generation 10Annex E (informative) Braille
18、 character sets 12Bibliography .13BS EN ISO 17351:2014ISO 17351:2013(E)ForewordISO (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 techni
19、cal 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 w
20、ith 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 Inter
21、national 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
22、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 reservedBS EN ISO 17351:2014ISO 17351:2013(E)IntroductionThis International Standard has been de
23、veloped 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
24、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 o
25、n 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
26、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 vBS EN ISO 17351:2014BS EN ISO 17351:2014Packaging
27、 Braille on packaging for medicinal products1 ScopeThis 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
28、 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-type cell2.3burst-throughcracking, breaking, pin-holing of the coating
29、 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 between the Braille cellsNote 1 to entry: The Marburg Medium spacing conven
30、tion 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 the medicinal product on the market3 General requirements for medicinal
31、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.INTERNATIONAL STANDARD ISO 17351:2013(E) ISO 2013 All rights reserved 1BS EN IS
32、O 17351:2014ISO 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) as amended by Directive 2004/27/EC.1NOTE 1 Guidance on the informati
33、on 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 text placem
34、entThe 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 an
35、d 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 specify th
36、e 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 Braille cell d
37、ot 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 order to
38、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 0,20 mm wit
39、h 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
40、 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 cell dot fo
41、rmation contained within Annex C can be taken into account in order to achieve Braille cell dot height requirements.2 ISO 2013 All rights reservedBS EN ISO 17351:2014ISO 17351:2013(E)NOTE 2 Burst-through can occur when the substrate or any surface coating fractures, causing damage to print and/or su
42、rface 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 wit
43、h a burst-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
44、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. ISO 2013 All rights reserved 3BS EN ISO 17351:2014ISO 17351:2013(E)Annex A (normative) Methods of v
45、erificationA.1 Braille cell dot 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 c
46、alibrated, 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 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 o
47、f 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 be carried out across all stations; see C.5.2. Checks should also be made to ensure the readability of unde
48、rlying printed text.A.2 Product 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 sa
49、mples can be tested for Braille 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 testing 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.4 ISO 2013 All rights reservedBS
