Discussion on Construction of a Medical Device Software Standard System
PENG Liang1, ZHENG Jia2, YU Xin-hua2
1. Center for Medical Device Evaluation of CFDA, Beijing 100044, China; 2. National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration of CFDA), Beijing 100050, China
Abstract：In combination with the investigation of the relevant IEC medical device software standards and the analysis of its classification 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 classified 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.
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, 30(3): 59-62.
PENG Liang, ZHENG Jia, YU Xin-hua. Discussion on Construction of a Medical Device Software Standard System. China Medical Devices, 2015, 30(3): 59-62.
