摘要
依据国家标准GB/T16175-1996,选择10项试验对Firebird冠脉涂膜支架系统进行生物学安全性评价,结果表明该支架系统的血液相容性良好,无全身毒性和细胞毒性,无热源性、致敏性、刺激性,也无遗传毒性,组织相容性尚可是一种生物相容性优良的Firebird冠脉涂膜支架系统。
We conducted 10 experiments to evaluate the biological safety of the Firebird drug-coated stent systems according to
the national standard(GB/T16175-1996). The experiment results demonstrate that the Firebird drug coated stent
systems have a good hemo-compatibility. no cytotoxicity, systemic toxicity (acute toxicity), sensitization, intracutaneous
reactivity,pyrogen,genotoxicity. Therefore, we conclude that the biocompatibility and the safety of the Firebird drug
coated stent systems are good.
出处
《中国医疗器械杂志》
CAS
2004年第3期185-189,共5页
Chinese Journal of Medical Instrumentation
