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ISO 10993-5:1999

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

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 either directly or through diffusion

  • with extracts of a device, and/or
  • in contact with a device.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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