医疗器械软件标准体系建设探讨

摘要

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.%基于我国软件工程标准的划分方法，结合IEC医疗器械软件相关标准的调研及其标准划分方法，本文提出了我国医疗器械软件标准体系建设的基本原则和工作建议。我国医疗器械软件标准可以从监管用途和适用范围两个维度进行分类，技术机构可以采取分阶段逐步推进的方式进行筹建，标准实施需要考虑我国国情和监管体制。