EN 30993-5:1994

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992) EN 30993-5:1994

Scope

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

Related legislation

Legislation related to this standard