本文件提供了健康软件和健康IT系统的原则、概念、术语和定义，以及从概念到退役的整个生命周期中安全、有效性和安全性的关键属性，如图1所示。它还确定了生命周期中发生责任转移的过渡点，以及在这些过渡点所需的多边沟通类型。本文件还为其他标准建立了一致的概念和术语，这些标准涉及健康软件和健康IT系统的安全性、有效性和安全性（包括隐私）的特定方面。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 provides the principles, concepts, terms and definitions forhealth softwareandhealth IT systems, key properties of safety, effectivenessandsecurity, across the fulllife cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition points in thelife cyclewhere transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of thesafety, effectiveness,andsecurity(including privacy) ofhealth softwareandhealth IT systems.All current amendments available at time of purchase are included with the purchase of this document.