用于人工髋关节领域的表面涂层评价方法  

Evaluation methods of surface coating in artificial hip joint

作　　者：张家振 翟豹 闵玥 田佳鑫[1] 刘斌[1] Zhang Jiazhen, Zhai Bao, Min Yue, et al(Center for Medical Device Evaluat ion, China Food and Drug Administrat ion, Bei j ing, 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,北京100081

出　　处：《生物骨科材料与临床研究》2018年第2期76-80,共5页Orthopaedic Biomechanics Materials and Clinical Study

摘　　要：目的对在人工髋关节中的表面涂层技术评价方法做一总结。方法查阅该领域的相关文献、相关技术标准、国内外监管机构公开资料等进行总结。结果评价主要涉及以下方面:涂层的成分及体视学、机械性能、涂层稳定性及耐腐蚀性能、涂层生物相容性等产品性能的评估。结论涂层技术的进步需要加强基础研究能力,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,同时也为注册申报提供充分的支持性数据。Obj ective To review the standard, guideline and technical data of the coating for artificial hip j oint prosthesis. Methods Recent literature concerning registration for the coating of artificial hip joint prosthesis was reviewed and anal-yzed. Results The aspects of the evaluation for coating of the artificial hip joint prosthesis include chemical composition, morphology, mechanical properties, environmental stability, corrosion resistance, biocompatibility and so on. Conclusion The main difficulty in registration is how to prepare the research data of the product, so 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：人工髋关节 多孔涂层 性能评价 

分 类 号：R318.08[医药卫生—生物医学工程]