外科植入物超高分子量聚乙烯形态学分析研究  

Research on the Morphology Assessment of Ultra-High-Molecular-Weight-Polyethylene About Surgical Implants

作　　者：安俊波 董双鹏[1,2] 马金竹 李立宾[1] 李沅 张述 张皓成[1] AN Jun-bo;DONG Shuang-peng;MA Jin-zhu;LI Li-binLI Yuan;ZHANG Shu;ZHANG Hao-cheng(Tianjin Medical Device Quality Supervision and Testing Center,Tianjin 300384;Key Laboratory of Quality Evaluation for Passive Implant Devices of the National Medical Products Administration,Tianjin 300384)

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384 [2]国家药品监督管理局无源植入器械质量评价重点实验室,天津300384

出　　处：《中国医疗器械信息》2024年第17期28-30,101,共4页China Medical Device Information

摘　　要：超高分子量聚乙烯关节置换植入物模塑料形态质量的检测,是评价其模塑质量的重要指标。文章通过研究未完全熔融的超高分子量聚乙烯片状粒子数量来评价超高分子量聚乙烯模塑料的形态学特征,评价超高分子量聚乙烯模塑料相对固化质量。模塑固化良好的超高分子量聚乙烯材料中,未完全熔融的超高分子量聚乙烯片状粒子很少或没有。视场中黑色边界线分隔的每个单独区域,是一个个粉料粒子经模塑挤压后形成的,黑色边界线是挤压成型的粉料粒子边界,定义为熔融片状形态粒子边界。未熔融粉料粒子定义为未熔融片状形态A或B,不宜称之为A、B缺陷,将缺陷A和缺陷B分别修改为未熔融片状形态A和未熔融片状形态B。2023年全国外科植入物和矫形器械标准化技术委员会对YY/T 0772.5-2009《外科植入物超高分子量聚乙烯第5部分:形态学评价方法》(项目编号20221592-T-464)进行了修订,修订后该标准编号变更为GB/T 19701.5《外科植入物超高分子量聚乙烯第5部分:形态学评价方法》(报批稿)。对于未熔融粉料粒子定义为未熔融片状形态A或B,将缺陷A和缺陷B分别修改为未熔融片状形态A和未熔融片状形态B,促进标准的理解和使用。The morphological quality of ultra-high-molecular-weight-polyethylene is an important index to evaluate its molding qualityforjoint replacement implants.In this paper,the morphology of ultra-high-molecular-weight-polyethylene molding compound and the relative curing quality of Ultra-high-molecular-weightpolyethylene molding compound were evaluated by studying the number of flake particles of ultra-high-molecular-weight-polyethylene.In the ultra-highmolecular-weight-polyethylene materials with good molding cure,there are few or no flake particles of ultra-high-molecular-weight-polyethylene which are not completely melted.The black boundary line is the boundary of extruded powder particles,which is defined as the boundary of molten flake shape particles.For the unfused powder particles defined as the unfused flake shape A or B,it is not suitable to call them as A and B defects.In 2023,the National Committee of Surgical implantation and the standardization technical committee modified the YY/T 0772.5-2009“Implants for surgery-ultra-high-molecular-weightpolyethylene Part 5:Morphology assessment method”.After the revision,the standard number was changed to GB/T 19701.5“Implants for surgery-ultra-highmolecular-weight-polyethylene Part 5:Morphology assessment method”(approval draft).The defects A and B are modified as the unfused flake shape A and the unfused flake shape B,respectively,promote the understanding and use of standards.

关 键 词：外科植入物 超高分子量聚乙烯 形态学 熔融 

分 类 号：TB324[一般工业技术—材料科学与工程]