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ANSI/AAMI/ISO 10993-5:2009 (R2022)

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

This standard describes test methods to assess the in vitro cytotoxicity of devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts of the 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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Association for the Advancement of Medical Instrumentation [aami]

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