医疗器械中应用的纳米材料安全性评价研究进展  

Research Progress in Safety Evaluation of Nanomaterials Used in Medical Devices

作　　者：叶晴 柯军[1] 卢翰生 洪黄立 YE Qing;KE Jun;LU Han-sheng;HONG Huang-li(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2022年第19期9-11,共3页China Medical Device Information

摘　　要：结合毒理学和毒代动力学,以纳米材料的表征、暴露途径、毒代动力学和毒理学分析建立了纳米材料医疗器械的安全性评价框架,并确定了纳米材料医疗器械的安全性评价流程,包括纳米颗粒释放的概率、纳米粒子的分布、毒理学评估以及风险评估。展望了纳米材料医疗器械安全性研究的发展趋势,以使得纳米材料医疗器械更加的安全。This article combines research on toxicology and toxicokinetics of nanomaterials,based on the characterization,exposure route,toxicokinetics and toxicological analysis of nanomaterials,the safety evaluation framework of nanomaterial medical devices has been established.And determined the safety assessment process of nanomaterial medical devices,including nanoparticle release probability,nanoparticle distribution,toxicology assessment and risk assessment.Looking forward to the development trend of nano-material medical device safety research,so as to make the nano-material medical device safer.

关 键 词：纳米材料 纳米医疗器械 生物安全性 风险评估 危害途径 

分 类 号：TB324[一般工业技术—材料科学与工程]