标准摘要
[中文适用范围]： ISO 10993 的这一部分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和/或装置提取物接触的培养细胞的孵育。 这些方法旨在使用适当的生物参数确定哺乳动物细胞体外的生物反应。 [外文原描述]： 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.
英文名称Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity