IEC 80001-1:2021 包含医疗设备的IT网络的风险管理应用.第1部分:连接医疗设备或连接健康软件的实施和使用中的安全性、有效性和安全性

标准编号：IEC 80001-1:2021

中文名称：包含医疗设备的IT网络的风险管理应用.第1部分:连接医疗设备或连接健康软件的实施和使用中的安全性、有效性和安全性

英文名称：Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

发布日期：2021-09-21

标准范围

IEC 80001-1:20 21规定了组织在医疗IT基础设施内连接医疗IT系统之前、期间和之后应用风险管理的一般要求，通过解决安全、有效性和安全性的关键属性，同时让适当的利益相关方参与进来。IEC 80001-1:20 21取消并取代了2010年发布的第一版。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)改变结构以更好地符合ISO 31000；b)制定组织应用风险管理的要求；c)通过支持在实施和使用互联健康软件和/或健康IT系统期间保护关键属性的原则，传达风险管理的价值、意图和目的。

IEC 80001-1:2021 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.

标准预览图