A standard for Pharmaceutical Packaging Braille was recently completed and adopted by the European Standards Organisation (CEN) (Standard EN 15823) and is now available in the UK as British Standard BS EN 15823:2010 entitled “Packaging – Braille on Packaging for Medicinal Products”.
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.
This European Standard is the result of a number of years of work by a CEN Working Group encompassing organisations for the visually impaired, health agencies, the pharmaceutical industry, and packaging and materials suppliers. It specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.
Braille Dot Height
Of particular note, the new standard sets out the basic physical parameters for the height of Braille dots on pharmaceutical packaging:
“For embossed materials the target Braille cell dot height shall be 0,20mm… “
The recommendation for Braille dot height was arrived at following the results of research at University of Brimingham into the effect of dot elevation on the legibility of Braille on pharmaceutical products. The document also gives details of methods for the measurement of Braille dot height to ensure that legibility is validated.
Contains Pharmaceutical Braille Guidance and Information
A significant amount of information can also be found in the publication, providing guidance on Braille for pharmaceutical packaging and its application. This is contained in a number of annexes to the document. These include Braille characteristics, technology for the application of Braille to pharmaceutical packaging, artwork generation, Marburg Medium Standard and Braille character sets.
It is hoped that the development of the standard will enable manufacturers to rationalise across Europe their approach to the fulfilment of the requirement of the medicines legislation to apply Braille to all packs of medicinal products.
BS EN 15823:2010 “Packaging. Braille on packaging for medicinal products” may be purchased online from the BSI Shop
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