Biological evaluation of medical devices-Tests for in vitro cytotoxicity
医疗器械的生物学评价
发布日期:
2009-07-31
BS EN ISO 10993-5:2009描述了评估医疗器械体外细胞毒性的试验方法。BS EN ISO 10993-5:2009规定了直接或通过扩散与设备和/或设备提取物接触的培养细胞的培养。BS EN ISO 10993-5:2009旨在通过使用
适当的生物学参数。交叉引用:ISO 10993-1ISO 10993-1293/42/EEC90/385/EECAll购买本文件时提供的当前修订包括在购买本文件中。
BS EN ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.BS EN ISO 10993-5:2009 specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.BS EN ISO 10993-5:2009 are designed to determine the biological response of mammalian cells in vitro using
appropriate biological parameters.Cross References:ISO 10993-1ISO 10993-1293/42/EEC90/385/EECAll current amendments available at time of purchase are included with the purchase of this document.