固体生物材料的补体激活作用研究现状

Current Status of the Study on Complement Activation by Solid Biomaterial

目的为提高我们对固体生物材料补体激活作用的认识,为如何进行固体生物材料以及相应血液接触类医疗器械生物安全性评价奠定基础。方法分析现行标准中对固体生物材料补体激活测试的最新要求,以及如何选择相关标准进行检验。结果与结论鉴于目前国际上还没有统一、认可的固体生物材料补体激活作用检测的标准,故亟需制定相应的标准来规范该项测试要求。

OBJECTIVE To improve our comprehensions to complement activation by biomaterial and lay the foundation for biosafety evaluation of solid biomaterials together with the corresponding blood contacting medical devices. METHODS Analyzed new requirements of current standards on complement activation by solid biomaterial as well as the mechanism of complement activation by solid biomaterial and how to select the related standards for inspection. RESULTS AND CONCLUSION The new edition of international standards has enhanced types of blood contacting medical devices which are appropriate to complement activation test. It is badly in need of establishing the corresponding industry standards to regulate these requirements, since there have no uniform and admissive methods for inspection of complement activation by solid biomaterial.