《外科植入物用高纯氧化铝陶瓷材料》ISO 6474-1:2010与ISO 6474:1994主要差异解析  

Parse of Primary Difference Between ISO 6474-1:2010 and ISO 6474:1994 Implants for Surgery-Ceramic Materials Based on High Purity Alumina

作　　者：马春宝[1] 李沅[1] 姜熙[1] 樊铂[1] 

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗器械信息》2013年第4期39-43,共5页China Medical Device Information

摘　　要：本文详细比较了《外科植入物用高纯氧化铝陶瓷材料》ISO 6474-1:2010新版标准与ISO6474:1994原版标准之间的差异,并对新旧标准在分类、材料性能、样品制备、试验方法、试验报告等方面的差异进行了详细的分析和解读。本文可使相关人员加深对新版标准的理解,有助于更全面、系统地掌握和应用新版标准。This paper compares the differences lmplants for Surgery-Ceramic materials based on high purit.v alumina between ISO 6474- 1：2010 new standard and ISO 6474：1994 original standard. The old and new standards in the classification, material properties, sample preparation, test method, test report and other differences are analyzed in detail and explanation. In this paper, the relevant person deepen the understanding of the new standards, conduce to more comprehensive, systematic mastery and application of new edition standard.

关 键 词：ISO 6474 差异 解析 

分 类 号：R318.08[医药卫生—生物医学工程]