BS EN ISO 10993-5:2009+A11:2025 - Page 2

Biological evaluation of medical devices. Tests for in vitro cytotoxicity | Status: Current

1 Scope 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 in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.