Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN ISO 10993-5:2009
• Năm ban hành / Publication date: 2009
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
• Phạm vi áp dụng / Scope of standard: 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.