EVS-EN ISO 10993-23:2021

ISO 10993-23 specifies the procedure for the assessment of medical devices regarding their potential to produce irritation by using an in vitro reconstructed human epidermis model. The tests included in the standard are important tools for the development of safe products.

ISO 10993-23 includes:

— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure,

— details of in vitro and in vivo irritation test procedures,

— key factors for the interpretation of the results.

The text of ISO 10993-23:2021 has been approved in Europe as EN ISO 10993-23:2021 without any changes.