髋关节置换术用丙烯酸骨水泥性能评价的关注点  

Key Attentions on Properties Evaluation of Polymethylmethacrylate(PMMA) Bone Cements Used in Total Hip Arthroplasty

作　　者：张家振 翟豹 田佳鑫[1] 闵玥 刘斌[1] ZHANG Jiazhen;ZHAI Bao;TIAN Jiaxin;MIN Yue;LIU Bin(Center for Medical Device Evaluation,China Food and Drug Administration,Beijing 100081,China.)

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京市100081

出　　处：《组织工程与重建外科杂志》2018年第3期174-177,共4页Journal of Tissue Engineering and Reconstructive Surgery

基　　金：国家重点研发计划(2017YFB1104105)

摘　　要：经查阅髋关节置换术用丙烯酸骨水泥的相关文献、相关技术标准、产品指导原则等,认为对骨水泥的评价主要涉及骨水泥的单体残留、凝固行为、机械性能和生物相容性等产品性能。生产企业应加强骨水泥产品的基础研究能力,制定科学的技术指标和试验方法,以确保产品的安全有效性,同时也可为注册申报提供充分的支持性数据。The recent literature, standard and guideline for PMMA bone cements used in total hip arthroplasty was reviewed and analyzed. The aspects of the evaluation for PMMA bone cements used in total hip arthroplasty include chemical composition, residual monomer, mechanical properties, working curves of bone cement, biocompatibility and so on. The manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.

关 键 词：丙烯酸骨水泥 单体残留 特性曲线 机械性能 

分 类 号：R318.17[医药卫生—生物医学工程]