ISO 80001国际标准——关于医疗设与网络集成之风险管理  

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

作　　者：郑焜[1] 谢松城 管炜桥 陈龙[1] 

机构地区：[1]浙江大学医学院附属儿童医院信息科,浙江杭州310003 [2]浙江省医疗设备管理质控中心,浙江杭州310012

出　　处：《中国医疗设备》2012年第8期93-94,124,共3页China Medical Devices

摘　　要：医疗设备集成IT网络后,确保医疗设备安全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全面风险管理的协作过程,以及医院、IT厂商和医疗设备厂商在其中的角色和行为。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。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.

关 键 词：医疗设备 信息技术 IT网络 集成 风险管理 

分 类 号：TP393.08[自动化与计算机技术—计算机应用技术] R197.324[自动化与计算机技术—计算机科学与技术]