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Status : Active
Standard Type : Main
Document No : ISO 10993-5:2009
Document Year : 2009
Pages : 34
Edition : 3
Section Volume : Biological evaluation of medical devices (ISO/TC 194.)
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.