外科植入物用超高分子量聚乙烯氧化指数测试方法的国内外标准对比分析  

Comparative Analysis of Domestic and Foreign Standards of Implants for Surgery-Ultra-High Molecular Weight Polyethylene Oxidation Index Measurement Method

作　　者：张旺 姜熙[1] 马春宝[1] ZHANG Wang;JIANG Xi;MA Chun-bao(Supervision and Testing Center for Medical Devices of Tianjin,Tianjin 300382)

机构地区：[1]国家药品监督管理局天津市医疗器械质量监督检验中心,天津300382

出　　处：《中国医疗器械信息》2023年第5期35-38,共4页China Medical Device Information

摘　　要：通过对比分析外科植入物用超高分子量聚乙烯氧化指数测试方法的ISO、ASTM及国内医疗器械行业标准,采用红外光谱法对多组样品的相对氧化程度进行研究,得出以下结论,国内外标准计算氧化峰面积设置的积分范围不同,按照不同标准计算的同一样品的氧化峰面积结果会产生差异,因此建议根据样品的氧化水平选择适宜的氧化峰积分范围来计算氧化指数。By comparing and analyzing the ISO,ASTM and domestic medical device industry standards of the oxidation index test methods of UHMWPE for surgical implants,the relative oxidation degree of multiple groups of samples was studied by infrared spectroscopy,and the following conclusions were drawn:In view of the different integration ranges of the oxidation peak area calculated by domestic and foreign standards,the results of the oxidation peak area of the same sample calculated according to different standards will be different.It is suggested to select the appropriate integration range of oxidation peak to calculate the oxidation index according to the oxidation level of the sample.

关 键 词：超高分子量聚乙烯 氧化指数 

分 类 号：TB324[一般工业技术—材料科学与工程]