ISO 11978:2017

Overview

ISO 11978:2017 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling - specifies the information manufacturers must provide to support the correct and safe use of contact lenses, accessories and care products by both eye care professionals and contact lens wearers. The standard defines required label elements, legibility criteria and guidance on using symbols, but does not prescribe the label format (package, leaflet, electronic media, etc.).

Key SEO keywords: ISO 11978:2017, ophthalmic optics, contact lenses, labelling, contact lens care products, instructions for use, manufacturer labelling.

Key topics and requirements

• Scope: Information required for contact lenses and contact lens care products to ensure safe use by professionals and wearers.
• Language & symbols: Information should be provided in the language(s) of the market where the device is distributed. Symbols are encouraged and shall conform to ISO 15223‑1; undocumented symbols must be explained in supplied documentation.
• Legibility: All symbols and written information shall be a minimum of 0.7 mm in height and legible at 30 cm under 215 lx illumination (except trademarks and manufacturing part numbers).
• Mandatory label elements (examples):
  • Manufacturer name/trade name and address
  • Product identification, material name and contact lens parameters
  • Number of lenses or contents (mass/volume)
  • Packaging/storage solution and preservative identification (if applicable)
  • Sterility statement and sterilization method (if applicable)
  • Lot number and expiry date
  • Single‑use or custom‑made statements (if applicable)
  • Instructions for use or “Attention: See instructions for use” symbol
  • Replacement schedule and recommended wear regimen (daily/extended)
  • Contraindications, warnings, precautions and adverse reaction guidance
  • Cleaning, maintenance, hygienic handling, insertion/removal instructions (for lenses)
  • Maximum period of use after opening, system compatibility and “Keep out of reach of children” (for care products)
• Flexibility: Manufacturers may choose where to place information (primary container, secondary packaging, leaflet), provided all minimum requirements are met.

Applications and who uses it

• Manufacturers and label designers: to develop compliant labelling for contact lenses and care products.
• Regulatory and quality teams: to align packaging and instructions with international best practices and identify gaps vs. national regulations.
• Distributors and importers: to verify that product labelling meets destination market expectations.
• Eye care professionals and clinicians: to understand what information should be provided to patients.
• Compliance consultants and auditors: to assess conformity and prepare technical documentation.

Related standards

• ISO 15223‑1: Symbols for medical device labels and information
• ISO 18369‑1: Vocabulary and labelling recommendations for contact lenses
• ISO 14729: Microbiological requirements for contact lens care products
• ISO 14534: Fundamental requirements for contact lenses and care products

ISO 11978:2017 is a practical reference for ensuring clear, safe and internationally harmonized labelling of contact lenses and their care systems.