摘要
聚酯聚乙烯复合膜/聚乙烯(冠脉支架系统)是一种新型医用高分子生物材料,应用于临床,为心肌血运重建的主要手段。本研究按照ISO111737标准对其进行了辐照灭菌的剂量设定。依据ISO10993标准对辐照灭菌后的产品,进行了血小板黏附性能、Ames和微核试验。结果显示,辐照灭菌后的聚酯聚乙烯复合膜/聚乙烯(冠状动脉支架系统)无遗传毒性(不会引起染色体畸变);无诱导骨髓多染红细胞微核发生率增高以及无致癌作用。辐照灭菌不影响聚酯聚乙烯复合膜/聚乙烯(冠状动脉支架系统)的稳定性,辐照后的产品未发生毒性作用,生物相容性良好,辐射灭菌作为医用高分子生物材料灭菌方法值得推广应用。
As polyester polyethylene composite membrane/polyethylene is a new type of biological material suitable for clinical uses, the products were conducted dosage setting for radiation sterilization in accordance with ISO111737 in order to certificate if they are safe after radiation sterilization by use of platelet adhesion performance test, Ames test and the mieronucleus test referred to ISO10993. It has been confirmed that after radiation sterilization the material have no genetic toxicity （not cause chromosomal aberrations） and can not increase the incidence of the micronucleus of the bone marrow polychromatocytes cells though there is no carcinogenic effects. Radiation sterilization does not affect the stability of the polyester polyethylene composite membrane/polyethylene （coronary artery stents）. It means that as a good method radiation sterilization is worth to promote.
出处
《辐射研究与辐射工艺学报》
CAS
CSCD
北大核心
2008年第5期289-294,共6页
Journal of Radiation Research and Radiation Processing
关键词
血液相容性
辐射灭菌
致畸毒性冠状动脉支架
Hemocompatibility, Radiation sterilization, Eratogenicity toxicity, Coronary stent
