BS EN ISO 10993-5-2009 医疗器械生物学评价.第5部分:细胞毒性体外试验法(ISO 10993-5-2009)

标准号：BS EN ISO 10993-5-2009
中文标准名称：医疗器械生物学评价.第5部分:细胞毒性体外试验法(ISO 10993-5-2009)
英文标准名称：Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
标准类型：C37
发布日期：2009/7/31 12:00:00
实施日期：2009/7/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.20
引用标准：ISO 10993-1;ISO 10993-12
适用范围：This part of ISO 10993 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.