DIN EN ISO 11980:2013-03

The standard specifies guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products required for fulfilment of the marketing and labelling requirements for contact lenses and contact lens care products around the world. It gives the elements of a clinical investigation of these product groups and states the procedures for the evaluation of safety, physiological performance and effect on ocular tissues. The evaluation of visual, refractive and lens performance and subject acceptance are also given in the standard. Currently, contact lenses and contact lens care products are regulated in different ways in different countries. The International Standard ISO 11980 has been developed to encourage global harmonization. Its widespread adoption should represent yet another step toward mutual recognition. With respect to the edition from March 2010, only small modifications have been made: the reference to the horizontal standard relating to clinical investigation has been updated, DIN EN ISO 14155, has been amended to the new edition of that standard. In addition, the number of cases for orthokeratology lenses has been changed. The standard has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" with German collaboration. At DIN, the responsible Working Committee is NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") at NAFuO.