Overview
ISO 11978:2017/Amd 1:2020 is an amendment to the international standard for ophthalmic optics, specifically addressing labelling requirements for contact lenses and contact lens care products. Published by the International Organization for Standardization (ISO), this amendment introduces enhanced guidelines aimed at ensuring label readability and accessibility through standardized text height and colour contrast requirements. The changes are vital for product safety, proper usage, and regulatory compliance within the ophthalmic optics industry.
Key Topics
- Minimum Text and Symbol Size: All written information and symbols intended for users must have a minimum height of 0.7 mm for black text or symbols on a white background. This ensures clarity and legibility.
- Colour Contrast Requirements: When using any colour combination other than black on white, labels must maintain at least a 3:1 contrast ratio between the text (or symbol) and background, calculated using RGB colour values.
- Colour Conversion Guidance: For printed labels using CMYK colours, the amendment introduces the requirement to convert these values to RGB to accurately assess contrast ratios.
- Contrast Calculation Methods: Annex A is added to provide detailed guidance on calculating contrast ratios using the sRGB colour space, with practical examples and references to online calculators.
- Reference to International Best Practices: The amendment cites authoritative sources such as IEC 61966-2-1 for colour management, W3C Web Content Accessibility Guidelines (WCAG), and the CIE 1931 Color Spaces.
Applications
Implementing ISO 11978:2017/Amd 1:2020 delivers practical benefits across several areas in the contact lens industry:
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Manufacturers of Contact Lenses and Care Products
- Improve packaging design by ensuring information is legible for all users, including those with visual impairments.
- Facilitate compliance with global regulatory requirements for product labelling.
- Enhance user experience and minimize misinterpretation of instructions, warnings, or critical product information.
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Regulatory Affairs and Quality Assurance
- Ensure products meet international standards for labelling, supporting market entry and distribution in multiple regions.
- Streamline product approval processes by adhering to the latest safety and accessibility guidelines.
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Retailers and Distributors
- Provide assurance to end-users that the information on contact lens packaging meets established readability and accessibility criteria.
- Reduce product returns and consumer complaints stemming from unclear labelling.
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Healthcare Professionals and Users
- Enable safer handling and use of contact lenses and associated care products.
- Support informed decision-making and proper compliance with usage instructions.
Related Standards
- ISO 11978:2017: The main international standard for labelling contact lenses and care products, providing general requirements for safety and information.
- IEC 61966-2-1: Defines the default sRGB colour space used for contrast calculations.
- W3C Web Content Accessibility Guidelines (WCAG) 2.1: Referenced for best practices in contrast ratios and accessibility.
- CIE 1931 Color Spaces: Provides the basis for colour and luminance calculations used in determining acceptable contrast.
By following ISO 11978:2017/Amd 1:2020, organizations demonstrate their commitment to product safety, regulatory compliance, and accessibility, ensuring consistent quality and user confidence across the global ophthalmic optics market.
Open preview (PDF)Ophthalmic optics — Contact lenses and contact lens care products — Labelling — Amendment 1
