Braille on packaging for medical devices and healthcare products

Council Directive 2004/27/EC [1] introduces the need to include on the outer packaging of authorized medicinal products their names in Braille as an aid to identification for blind and partially sighted people.

Key standards for medical devices products and healthcare packaging

BS EN 15823:2010
Packaging. Braille on packaging for medicinal products 

BS EN 15823 is the standard aimed at supporting the implementation of Braille on medicinal products in the European Union (EU) and European Economic Area (EEA) and in particular, Part 1 of the associated European Commission Braille Implementation Guidelines. BS EN 15823 specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

BS EN ISO 15378:2007
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

PD CEN/TR 15753:2008
Packaging. Package leaflets for medicinal products. Braille and other formats for visually impaired people .


 


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