ISO 10993-5:2009描述了评估医疗器械体外细胞毒性的测试方法。 这些方法指定直接或通过扩散与装置接触的培养细胞和/或装置的提取物的温育。 这些方法设计用于使用适当的生物学参数来确定哺乳动物细胞在体外的生物反应

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.