Medical Devices
Medical Device Biocompatibility: in vitro skin irritation testing
Under ISO 10993-23, skin irritation testing can now be performed using in vitro testing methods based on Reconstructed human Epidermis (RhE) models for medical device biocompatibility evaluation. Test materials are extracted into physiological saline and sesame oil (extraction performed under ISO 10993-12). Using the MTT reagent, tissue viability is assessed at the completion of the...
Vaginal Irritation
The irritation potential of pharmaceutical, cosmetic and personal care products, medical devices and related consumables (such as lubricants)* that are formulated for application onto human cervical or vaginal tissues can be evaluated using reconstructed organotypic models representative of human ecto-cervical and vaginal tissue. These models overcome some of the disadvantages of monolayer culture by the...