DIN EN ISO 13212:2014-12

The standard provides guidance on the design of stability studies for use in gathering information to enable determination of the storage period of contact lens care products. It does not address studies designed to obtain information to establish the in-use stability of contact lens care products. In the new edition which is now available in its draft form, the requirements concerning the relative humidity during the test shall be rendered more precise with regard to DIN EN ISO 13212:2011-08. Furthermore, when describing the number and nature of the batches tested, the requirement for the indication of all materials used for packaging that could impact the stability of the product shall be included. In informative Annex A, the examples have been brought in line with revised requirements concerning the relative humidity and references to relevant ICH-Documents have been supplemented. 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). At DIN, Working Committee NA 027-01-08 AA "Augenoptik" ("Ophthalmic optics"), Working Group "Kontaktlinsen" ("Contact lenses") at NAFuO is responsible.