Overview
EN ISO 11978:2017 (ISO 11978:2017) is an international standard for ophthalmic optics - contact lenses and contact lens care products - labelling. It specifies the information manufacturers must provide to ensure the correct and safe use of contact lenses and related care products by both eye care professionals and contact lens wearers. The standard sets content and legibility requirements but does not prescribe the exact format (packaging label, leaflet, or electronic media).
Key topics and technical requirements
- Scope: Required labelling content for both contact lenses and contact-lens-care products to support safe use.
- Language & symbols: Information should be provided in the language of the country of distribution where practicable; symbols may be used and shall conform to ISO 15223-1.
- Legibility: All symbols and written information must be a minimum of 0.7 mm in height and legible at a reading distance of 30 cm under an illumination of 215 lx (exceptions: trademarks and manufacturing part numbers).
- Permitted formats: Manufacturers may use primary/secondary packaging, leaflets, brochures or electronic media; format is at manufacturer’s discretion provided essential information is present.
- Minimum labelling content (high-level examples, as specified):
- Manufacturer name/address and authorized representative where required
- Product identification, material name, contact lens parameters, quantity
- Packaging/storage solution composition and preservative identification (or in IFU if space-limited)
- Sterility indication and sterilization method (if applicable)
- Lot number, expiry date
- Statements such as “For single use only” or “Custom made device” where applicable
- Intended use, storage/handling instructions, and replacement frequency
- Indications, contraindications, warnings, precautions, adverse reactions and emergency actions
- Guidance on cleaning, maintenance, hygienic handling, insertion/removal and not changing care systems or lens type without consulting an eye care professional
- Explicit warnings about contact with noxious vapours and exposure to non-sterile water (infection risk)
Applications - who uses this standard
- Contact lens and care-product manufacturers - create compliant labels, instructions for use (IFU) and packaging.
- Regulatory affairs and quality teams - ensure labelling meets ISO and regional regulatory expectations.
- Packaging designers and technical writers - apply legibility and content requirements.
- Eye care professionals and distributors - verify product information and advise patients.
- Notified bodies and conformity assessors - assess labelling as part of device compliance.
Related standards
- ISO 15223-1 - Symbols for medical device labelling (referenced for symbol use).
- ISO 18369-1 - Contact lens vocabulary, classification and labelling recommendations.
- Adopted as EN ISO 11978:2017 by CEN (European national standards implementation).
Keywords: ophthalmic optics, contact lens labelling, ISO 11978:2017, contact lens care, labelling requirements, medical device labelling, eye care professional, contact lens wearer.
