標準號：ANSI/AAMI/ISO 10993-5-2009
中文標準名稱：醫療器械生物學評價.第5部分:體外細胞毒性試驗
英文標準名稱：Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
標準類型：C37
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
適用范圍：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.