本文件定义了支持符合IEC 62443-4-1[11]所需的健康软件开发和维护的生命周期要求，并考虑了健康软件的具体需求。本文档中描述的一组过程、活动和任务为安全健康软件生命周期过程建立了一个通用框架。健康软件活动的非正式概述如图2所示。购买本文件时可获得的所有当前修订均包含在购买本文件中。

This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] - taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2.All current amendments available at time of purchase are included with the purchase of this document.