超高分子量聚乙烯在人工关节假体中的应用及评价方法  

Application and evaluation method of ultra high molecular weight polyethylene in artificial joints

作　　者：翟豹 张家振 刘斌 Zhai Bao;Zhang Jiazhen;Liu Bin(Center for Medical Device Evaluation,National Medical Product Administration,Beijing,100081,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081

出　　处：《生物骨科材料与临床研究》2020年第4期67-71,共5页Orthopaedic Biomechanics Materials and Clinical Study

摘　　要：本文通过查阅人工关节领域的相关文献、技术标准、产品指导原则等对超高分子量聚乙烯在人工关节中的应用及评价方法进行了总结。在假体设计开发时,需综合考虑假体设计和影响产品临床使用的风险因素,全面评价产品的材料性能、锁定强度、疲劳性能、体外磨损、生物相容性等,以确保产品的安全有效性。This paper summarizes the application of ultra-high molecular weight polyethylene in artificial joints and evaluation methods by consulting relevant literature, relevant technical standards, and product guidelines in the field of artificial joints. In the process of prosthesis design and development, it is necessary to comprehensively consider the risk factors of the prosthesis design and the clinical use of the product, and comprehensively evaluate the material properties, mechanical properties, wear properties, biocompatibility, etc. to ensure the safety and effectiveness of the product.

关 键 词：超高分子量聚乙烯 磨损 力学性能 生物相容性 

分 类 号：R318[医药卫生—生物医学工程]