醫材產品生物相容與安全性的考量 | 合法醫療器材資訊網

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact ... Read More

ISO 10993-5 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This third edition cancels and replaces the second​ ... Read More

ISO 10993-5 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This third edition cancels and replaces the second​ ... Read More

依據ISO10993-5 使用細胞培養技術，測試由醫療器材或其萃取物引起之細胞死. 亡、抑制細胞生長及其它效應。利用L929 纖維母細胞檢測樣品。 血液相容性試驗. - ... Read More

2017年3月28日 — ISO 10993-3 基因毒性、致癌性、生殖毒性. ISO 10993-4 血液相容性. ISO 10993-​5 體外細胞毒性. ISO 10993-6 植入試驗. ISO 10993-10 過敏性、 ... Read More

2018年10月26日 — ISO 10993-5:2009 医疗器械生物学评价——第5部分：体外细胞毒性试验 ISO 10993-5:2009 Biological evaluation of medical devices —Part ... Read More

ISO 10993. Required for all types of medical devices, cytotoxicity testing is a key element of the international standards. The international standards compiled as ... Read More

EN ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) Read More

2009年7月31日 — BS EN ISO 10993-5 has been revised and now contains informative annexes that identify the sections of the standard that conform to the Medical ... Read More