Βιολογική αξιολόγηση προϊόντων για ιατρική χρήση - Μέρος 5 : Δοκιμές για κυτταροτοξικότητα in vitro

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or trough diffusion a) with extracts of a device , and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.