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AAMI/AAMI/ISO 10993-5 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.
 

Document History

  1. AAMI/ISO 10993-5:2009/(R)2022

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    Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity

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  2. AAMI/ISO 10993-5:1999


    Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity

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