ISO 10993-5:2009 医疗器械的生物学评价 第5部分：体外细胞毒性试验

标准编号：ISO 10993-5:2009

中文名称：医疗器械的生物学评价 第5部分：体外细胞毒性试验

英文名称：Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

发布日期：2009-06

标准范围

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.

标准预览图