This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.
NOTE This International Standard attempts to harmonize the recognized regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world.
However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this International Standard.
BS EN ISO 11980:2009 history
2012BS EN ISO 11980:2012 Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
2009BS EN ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations