DIN EN ISO 11987:2012-11

This document describes the test procedures necessary for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution. The results obtained can be used for determining the expiry date. The standard deals both with the requirements for performing real time studies and accelerated ageing studies. Accelerated ageing studies simulate accelerated ageing of contact lenses in their final packaging and allow a statement on stability of the contact lens and the resulting shelf-life. The standard is primarily directed at contact lens manufacturers and the used solution(s) and containers as well as test institutes conducting such tests. With respect to the previous standard (DIN EN ISO 11987:1998-02), the requirement to perform a risk assessment has been incorporated. Furthermore, numerous specifications relating to the materials and apparatus, the test procedure and the expression of results and the test report have been rendered more precise. The standard has been prepared by ISO/TC 172/SC 7 "Ophthalmic optics and instruments" in collaboration with CEN/TC 170 "Ophthalmic optics" (both secretariats: DIN, Germany). The responsible Working Committee at DIN is NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") at NAFuO.