Based on many years of practical testing and contribution to the standardization work in the respective technical committees, “UL MDT” has gained special expertise in the experimental investigation and risk evaluation of ophthalmic devices.

The main focus of the investigations for intraocular lenses, contact lenses, capsular tension rings, viscosurgical devices and endotamponades is to verify the product properties and shelf-life assumptions as specified in the respective standards.

Our testing and assessment services for Ophthalmic products include:

  • Intraocular lenses
    • ISO 11979-2 – Optical Properties
    • ISO 11979-3 – Mechanical Properties
    • ISO 11979-5 – Biocompatibility
    • ISO 11979-6 – Shelf-Life and Transport Stability
    • Compatibility testing between Intraocular Lens Injector/Cartridge and Intraocular Lenses – Test parameters according to the FDA Guidance for intraocular lens testing
  • Contact lenses
    • ISO 18369-3 Determination of:
      • Spectral Transmittance
      • Back Vertex Power
      • Diameter
      • Thickness of Rigid Contact
      • Curvature of Rigid Contact Lenses
      • Inclusions and Surface Imperfections for Rigid Contact Lenses
    • ISO 18369-4 Determination of:
      • Oxygen Permeability and Transmissibility by the FATT Method
      • Refractive Index of Hydrogel Contact Lens Materials
      • Water Content of Hydrogel
      • Extractable Substance
    • ISO 11987 – Determination of Shelf Life
    • ISO 10993-5 – Cytotoxicity of Contact Lens Material

  • Contact lens care products
    • ISO 11986 – Preservative Uptake and Release
    • ISO 13212 – Shelf-life
    • ISO 14729 – Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses (Disinfection Performance)
    • ISO 14730 – Antimicrobial Preservative Efficacy Testing and Determination of the Discard Date

  • Compatibility between contact lenses and contact lens care products or eye drops
    • ISO 11981 – Physical Compatibility of Contact Care Products with Contact Lenses

  • Capsular tension rings
    • ISO 10993-1 _ Biological Standard tests
    • Dynamic Fatigue – Determination of the spring contact before and after mechanical exposure

  • Viscosurgical devices (ISO 15798) and endotamponades (ISO 16672)
    • Rheological and Physiochemical Properties
    • Biological Safety Testing per ISO 10993 and ISO 14971
    • Sterilization Verification and Validation
    • ISO 11607 and ISO 14630 – Product Stability and Packaging Integrity

Contact us for a free proposal on testing services.