ISO 10993-5:2009 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.
Status: PublishedPublication date: 2009-06
Edition: 3Number of pages: 34
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
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