浅析医疗器械软件相关标准  

Analysis of Medical Device Software Standards

作　　者：李佳戈[1] 刘艳珍[1] 苏宗文[1] 王建宇[1] 郑佳[1] 任海萍[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2013年第1期75-78,共4页Chinese Pharmaceutical Affairs

摘　　要：目的对医疗器械软件相关标准GB/T 25000.51-2010、YY/T 0708-2009及YY/T 0664-2008的理解和执行中存在的问题进行分析,供相关人员参考。方法对上述标准的内容与旧版标准进行比较,结合实际检测中遇到的问题展开讨论。结果与结论分析了新旧版标准之间的不同及新标准的主要内容,强调了新标准执行检测的要求。同时,对解决目前医疗器械软件检测面临的问题提出建议。Objective To analyze problems in the understanding and implementation of GB/T 25000. 51-2010, YY/T 0708-2009 and YY/T 0664-2008 for the reference for the relative personnel. Methods The differences between new and old edition standards were compared, and the problems were discussed in face of inspection practice. Results and Conclusion The differences between standards of new and old versions were analyzed, and the content of the new version was discussed as well, emphasizing the requirement of inspection implementation in the new version.

关 键 词：医疗器械 软件 标准 

分 类 号：TH77[机械工程—仪器科学与技术]