DIN EN ISO 10993-5-2009 医疗设备的生物评估.第5部分:体外细胞毒性测试(ISO 10993-5:2009),英文标准DIN EN ISO 10993-5:2009-10

标准号：DIN EN ISO 10993-5-2009
中文标准名称：医疗设备的生物评估.第5部分:体外细胞毒性测试(ISO 10993-5:2009),英文标准DIN EN ISO 10993-5:2009-10
英文标准名称：Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); English version of DIN EN ISO 10993-5:2009-10
标准类型：C30
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C30
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 deviceeither directly or through diffusion.These methods are designed to determine the biological response of mammalian cells in vitro usingappropriate biological parameters.