定义医疗设备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通用框架。 适用于当软件本身是医疗设备或软件是最终医疗设备的嵌入式或组成部分时，医疗设备软件的开发和维护。 本标准不包括医疗器械的验证和最终发布，即使医疗器械完全由软件组成。

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.