ISO 17351:2013

Overview

ISO 17351:2013 - Packaging - Braille on packaging for medicinal products specifies requirements and guidance for applying Braille on medicinal product packaging. It harmonizes national and regional requirements (notably European guidance) to ensure blind and partially sighted people can identify medicines by touch. The standard addresses what to label in Braille, acceptable application technologies, legibility verification and practical artwork and production considerations.

Key topics and technical requirements

• Scope and purpose: Requirements for Braille on immediate and outer packaging for medicinal products; principles can be applied to other sectors.
• Product identification: Braille text must include information required by the destination market (e.g., product name, form and strength where required).
• Braille placement: Braille must not reduce legibility of printed text; manufacturers are encouraged to position Braille away from printed graphics.
• Spacing convention: The Marburg Medium spacing convention is highly recommended unless a national requirement specifies otherwise.
• Braille character sets: Marketing authorization holders (MAHs) must specify appropriate Braille character sets for each market (see Annex E).
• Braille cell dot height and legibility:
  • Target dot height for production samples: 0.20 mm.
  • Embossed materials: strict limits on minimum acceptable measurements (with specified percentages allowed below thresholds).
  • Alternative methods (screen-printing, inkjet) have distinct measurement guidance.
  • If dot-height requirements cannot be verified, legibility testing with qualified Braille readers is required.
• Verification methods (Annex A): Measurement using a calibrated, spring-loaded micrometer across at least three places; statistical sampling agreed between customer and supplier.
• Production technologies (Annex C): Embossing (single- and two-pass), screen-printing, inkjet and tooling/positioning guidance are described.
• Artwork and specification guidance (Annex D) and character set tables (Annex E).

Practical applications and users

ISO 17351:2013 is intended for:

• Marketing authorization holders (MAHs) preparing market-specific labelling
• Pharmaceutical packaging and label manufacturers
• Print and tooling suppliers implementing Braille embossing or printing
• Regulatory affairs and quality assurance teams ensuring compliance
• Accessibility organizations and test labs conducting Braille legibility testing

Use cases include designing Braille artwork, validating production processes for embossed or printed Braille, and performing routine verification and legibility tests.

Related standards (if applicable)

• EN 15823:2010 (European standard referenced in development)
• European legislation cited in ISO 17351: Directive 2001/83/EC (as amended by 2004/27/EC)
• ISO/TC 122 (Packaging) is the responsible technical committee

Keywords: ISO 17351:2013, Braille on packaging, medicinal products, Braille labelling, Braille cell dot height, Marburg Medium spacing, embossing, screen-printing, packaging manufacturer, MAH.