ISO 11980 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidelines for Clinical Research

Material Testing

ISO 11980 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidelines for Clinical Research

This international standard provides guidelines for clinics regarding the safety and performance of contact lenses and contact lens care products.

ISO 11980 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidelines for Clinical Research

This international standard seeks to harmonize recognized regulatory requirements for the conduct of a CI to meet marketing and labeling requirements for contact lenses and contact lens care products worldwide. However, national requirements vary widely. Where national practice or regulation requires some legal requirement, this requirement takes precedence over this international standard.

Inclusion criteria for topic selection should be relevant to the study objectives and include;

  • Subjects 18 years of age or older with normal eyes not using any ocular medication;
  • Lens powers in the range available for test lenses;
  • Manifest cylinder equal to or less than 0,75;
  • Best eyeglass corrected visual acuity greater than or equal to 20/25.

Exclusion criteria for subject selection should be relevant to study objectives and include, but are not limited to:

  • Anterior segment infection, inflammation or abnormality;
  • Any active anterior segment ocular disease that may contraindicate contact lens wear;
  • The use of systemic or ocular drugs that are contraindicated against the use of contact lenses;
  • History of herpetic keratitis;
  • History of refractive surgery or irregular cornea;
  • Slit lamp findings more serious than 1st degree;
  • Corneal vascularization more than 1 mm penetration;
  • A pathologically dry eye.

EUROLAB assists manufacturers with ISO 11980 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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