本文件规定了组织在卫生IT基础设施内的卫生IT系统连接之前、期间和之后应用风险管理的一般要求，通过解决安全性、有效性和安全性的关键属性，同时让适当的利益相关者参与进来。IEC 80001-1:2021取消并取代了2010年发布的第一版。本版为技术修订版。与上一版相比，本版包括以下重大技术变更:a）结构变更，以更好地符合ISO 31000；b） 制定组织在风险管理应用中的要求；c） 通过支持在实施和使用互联健康软件和/或健康IT系统期间保护关键财产的原则，传达风险管理的价值、意图和目的。

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.