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.
出处
《中国药事》
CAS
2013年第1期75-78,共4页
Chinese Pharmaceutical Affairs
关键词
医疗器械
软件
标准
medical device
software
standard
