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现行 IEC/TR 80001-2-4:2012
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Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations 结合医疗设备的IT网络风险管理的应用第2-4部分:医疗服务提供组织的一般实施指南
发布日期: 2012-12-03
IEC/TR 80001-2-4:2012(E)是一份技术报告,它提供了指导,以帮助医疗服务机构履行其作为应用IEC 80001-1的责任组织的义务。医疗服务机构包括医院、医生办公室、社区护理院和诊所。具体而言,本指南有助于医疗服务提供组织评估IEC 80001-1对组织的影响,并建立一系列业务照常流程,以管理医疗IT网络创建、维护和维护过程中的风险。本技术报告将有助于那些负责在期望建立一个或多个医疗IT网络的医疗服务提供组织内建立符合IEC 80001-1的风险管理框架的人。在组织开始对医疗It的单个实例进行详细的风险评估之前,它通过建立风险管理框架所需的关键决策和步骤提供帮助- 网络这些步骤得到一系列决策点的支持,以指导责任组织了解医疗IT网络环境,并确定执行最高管理层职责所需的任何组织变革。
IEC/TR 80001-2-4:2012(E), which is a technical report, provides guidance to help a healthcare delivery organization fulfilling its obligations as a responsible organization in the application of IEC 80001-1. A healthcare delivery organization includes hospitals, doctors' offices, community care homes and clinics. Specifically, this guide helps the healthcare delivery organization assess the impact of IEC 80001-1 on the organization and establish a series of business as usual processes to manage RISK in the creation, maintenance and upkeep of its medical IT-networks. This technical report will be useful to those responsible for establishing an IEC 80001-1 compliant risk management framework within a healthcare delivery organization that is expecting to establish one or more medical IT-networks. It provides help through the key decisions and steps required to establish a risk management framework, before the organization embarks on a detailed risk assessment of an individual instance of a medical IT-network. The steps are supported by a series of decision points to steer the responsible organization through the process of understanding the medical IT-network context and identifying any organizational changes required to execute the responsibilities of top management.
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归口单位: ISO/TC 215
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