中国医疗设备Issue(3)：59-62,4.DOI:10.3969/j.issn.1674-1633.2015.03.017
医疗器械软件标准体系建设探讨
Discussion on Construction of a Medical Device Software Standard System
摘要
Abstract
In combination with the investigation of the relevant IEC medical device software standards and the analysis of its classiifcation method of medical device software standards, the basic principles and work suggestion were proposed in this paper for construction of a standard system for the medical device software based on the classification method of software engineering standards in China. The medical device software standards in China can be classiifed according to the regulatory purpose and application scope. The standard system of the medical device software can be established stage by stage by the standardization institution. Additionally, the national conditions and supervisory system in China should be taken into consideration in its implementation.关键词
医疗器械软件/软件标准/标准体系建设Key words
medical device software/software standard/standard system construction分类
医药卫生引用本文复制引用
彭亮,郑佳,余新华..医疗器械软件标准体系建设探讨[J].中国医疗设备,2015,(3):59-62,4.基金项目
国家技术支撑计划课题（2012BAI22B00）。 （）
