摘要
为探讨辐射灭菌后的医疗产品的安全性,对辐照灭菌后的中心静脉导管进行了细胞毒性、豚鼠迟发型接触性致敏和皮肤刺激试验以评价其组织相容性。辐射灭菌剂量采用ISO11137-2标准进行设定。结果表明:经辐照灭菌后的样品无细胞毒性、不会致敏和引起皮肤刺激,符合医疗器械组织相容性实验要求。提示经设定剂量辐照灭菌后的中心静脉导管组织相容性良好。
In order to inspect the security application of radiation sterilization medical products, the cytotoxicity, guinea pigs delayed contact sensitization and skin stimulation tests were carried out to evaluate the tissue compatibility of central vein catheter sterilized by irradiation and the radiation sterilization doses were set according to the ISO 11137-2 criterion. The results show that the radiation sterilized samples had no cytotoxicity, no sensitization and no intracutaneous activation that meet the request of tissue compatibility for medical products. It suggests that the central vein catheter sterilized by radiation with set absorbed dose has good tissue compatibility.
出处
《辐射研究与辐射工艺学报》
CAS
CSCD
2012年第3期165-169,共5页
Journal of Radiation Research and Radiation Processing
基金
江苏高校优势学科建设工程资助项目
关键词
辐射灭菌
中心静脉导管
组织相容性
Radiation sterilization, Central vein catheter, Tissue compatibility
