摘要
本文评价创伤系统使用材料鹅头钉钢板经辐射灭菌后的生物相容性,展望并促进辐射灭菌在医用高分子生物材料灭菌的应用。按照ISO111737标准进行鹅头钉钢板初始污染菌检测,采用初始污染菌回收率和校正因子表征,并依据ISO11137-2完成辐照灭菌的剂量设定;灭菌合格后进行遗传﹑血液相容性评价和热源评价试验。结果显示,鹅头钉钢板材质无遗传毒性(不会引起染色体畸变)、无热源、不会引起溶血。设定剂量辐照灭菌后的人工关节遗传和血液相容性好,辐照灭菌作为医用材料灭菌方法值得推广应用。
Evaluating biocompatibility of goose head nail steel plat after sterilizing by irradiation was performed to explore and promote radiation sterilization in biomedical material. Initial bacteria contaminated in goose head nail, its recovery rate and corrected factor were determined according to the standard ISO111737 while the absorbed dose setting was completed based on the Method 2 in standard ISO 11137. The blood compatibility and heat evaluation test was carried out after eligible radiation sterilization. The results indicate that neither genotoxicity nor heat source to induce the hemolysis was found in goose head nail steel plate after irradiation sterilization. It has been found that arti- ficial joint has good blood compatibility after irradiation sterilization. It suggests that irradiation sterilization could be used as an effective sterilization method.
出处
《辐射研究与辐射工艺学报》
CAS
CSCD
2011年第1期48-52,共5页
Journal of Radiation Research and Radiation Processing
关键词
遗传毒性
血液相容性
辐射灭菌
鹅头钉钢板
Genotoxicity, Blood-compatibility, Radiation sterilization, Trauma system
