SNV - SN EN ISO 11980
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
|Publication Date:||1 March 2013|
|ICS Code (Ophthalmic equipment):||11.040.70|
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 requiremts, this requirement take precedence over this International Standard.