Biological evaluation of medical devices - Tests for in vitro cytotoxicity

Biological evaluation of medical devices - Tests for in vitro cytotoxicity

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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.