本文件定义了支持符合IEC 62443-4-1所需的健康软件开发和维护的生命周期要求——考虑了健康软件的特定需求。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。目的是通过在健康软件生命周期过程中建立某些活动和任务，以及通过提高软件生命周期过程本身的安全性来提高健康软件的网络安全性。保持ISO 81001-1中讨论的关键特性安全性、有效性和安全性的适当平衡非常重要。本文件不包括随附文件内容的规范。

This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1 – 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.
The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves.
It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1.
This document excludes specification of ACCOMPANYING DOCUMENTATION contents.