ISO80001国际标准——关于医疗设与网络集成之风险管理

医疗设备集成IT网络后，确保医疗设备安伞运行及相关医疗信息安全可靠的交换和共享非常重要，医疗机构要确保这些医疗设备的正确使用。国际标准组织ISO最近推出的ISO80001自愿性标准即“医疗设备集成IT网络的风险管理应用”，旨在强调医疗设备集成于IT网络后如何保证系统安全有效和数据安全共享，描述了对集成医疗设备的网络体系进行令面风险管理的协作过程，以及医院、工厂商和医疗设备厂商在其中的角色不和行为。本文对该标准进行了介绍并提出了医学工程技术人员在其中的作用。

ISO 80001 International Standard---Risk Management of Medical Equipment and Network Integration

After medical equipment integrated into IT network, it is important to ensure those medical equipment work safely and efficiently, and make sure the related medical information exchange safely and reliably. Hospitals are obligated to ensure the correct use of medical equipment. The newly released ISO 80001 standard, namely, Risk Management of Medical Equipment and Network Integration, aims to emphasize how to ensure the system safe, effective and the data security sharing after medical equipment integrated into IT network. It describes the whole cooperation process of comprehensive risk management for the medical equipment integrated into the network system, and the roles and activities of hospitals, IT companies and medical equipment manufacturers. This paper gives an introduction about this new standard, and discusses the clinical engineers＇ role in this integration.