IEC 62304:2006+A1:2015定义了医疗器械软件的生命周期要求。本标准中描述的一组过程、活动和任务为医疗器械软件生命周期过程建立了一个通用框架。当软件本身是医疗器械或当软件是最终医疗器械的嵌入或组成部分时，适用于医疗器械软件的开发和维护。本标准不涵盖医疗器械的验证和最终放行，即使医疗器械完全由软件组成。 本合并版本由第一版（2006年）组成 及其修正案1（2015）。因此，无须在 本出版物的补充。

IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.