硅凝胶瘢痕贴的生物相容性

The Biological Assessment of Silicone gel film

目的对硅凝胶瘢痕贴进行生物学评价,为产品临床应用提供安全依据。方法参照GB/T 16886《医疗器械生物学评价标准》的要求,对硅凝胶瘢痕贴进行细胞毒性试验、皮肤刺激试验和迟发型超敏反应试验。结果样品的细胞反应为1级,无皮肤刺激反应和致敏反应。结论硅凝胶瘢痕贴具有良好的生物相容性。

Objective To provide integral biological assessment on carboxyl-amino-polysaccharide sodium biocolloid solution.Methods Conduct cytotoxicity tests and skin irritation test as well as skin sensitization according to GB/T 16886 Biological evaluation of medical devices.Results The cytotoxicity level was evaluated at the 1st level,while no skin irritation and sensitization were practically detected.Conclusion The results show that silicone gel film has good biocompatibility.