EN ISO 17351:2014 PDF

Overview

EN ISO 17351:2014 (ISO 17351:2013) is an international standard that specifies requirements and gives guidance for the application of Braille on packaging for medicinal products. Its purpose is to harmonize technical specifications so blind and partially sighted people can reliably identify medicinal products by touch. The standard applies to outer and immediate packaging and is intended for use by marketing authorization holders, packaging manufacturers and regulatory stakeholders in the pharmaceutical supply chain.

Key Topics and Requirements

• Scope and purpose: Defines terms (Braille, Braille cell, burst-through) and sets principles to ensure Braille enables product identification.
• Product identification in Braille: The approved Braille text shall include information required by the market (typically product name, and where required, form and strength).
• Braille spacing convention: The marketing authorization holder (MAH) must specify the spacing convention. Marburg Medium spacing is highly recommended unless national rules differ.
• Braille character sets: The MAH must specify the appropriate Braille character set for the target market (see Annex E).
• Braille cell dot height:
  • Target for embossed materials: 0.20 mm; not more than 5% of measurements lower than 0.12 mm, and not more than 1% lower than 0.10 mm.
  • For other methods (e.g., screen-printed labels): target 0.20 mm; not more than 5% lower than 0.16 mm.
• Legibility verification:
  • Measurement method: use a calibrated, spring-loaded micrometer (spring force ≥ 0.5 N) covering at least three Braille dots; measure in at least three places and report to two decimal places (Annex A).
  • If height requirements cannot be verified, legibility testing with qualified blind Braille readers may be used (protocol considerations listed in Annex A.2).
• Placement and alteration:
  • Braille must not reduce printed text legibility; placement should avoid covering printed graphics or text.
  • When altering Braille, any new Braille must totally obscure the original Braille text.
• Annexes: Include verification methods, recommendations on Braille characteristics, application technologies, artwork generation guidance and character sets.

Applications and Who Uses It

• Pharmaceutical manufacturers / MAHs: to ensure regulatory compliance and accessible packaging design.
• Packaging converters and printers: to implement embossing, printing or other Braille application technologies that meet dot-height and spacing requirements.
• Regulatory affairs and quality assurance teams: to validate Braille legibility and document compliance with EU directives referenced in the standard.
• Accessibility organizations and user-testing groups: to perform Braille legibility testing and provide user-centered validation.

Related Standards and References

• Supersedes EN 15823:2010.
• Implements ISO 17351:2013 text as EN ISO 17351:2014.
• References European directives on medicinal product labelling (e.g., Council Directive 2004/27/EC and Article 56 of Directive 2001/83/EC) and ISO/TC 122 Packaging guidance.

Keywords: Braille on packaging, medicinal products, Braille labelling, Braille cell dot height, pharmaceutical packaging standard, Marburg Medium, Braille legibility, embossed Braille.