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 ISO 17351:2014

Packaging. Braille on packaging for medicinal products 

BS EN ISO 15378:2017
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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