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现行 IEC TR 80001-2-5:2014
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Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems 包含医疗设备的IT网络的风险管理应用第2-5部分:应用指南分布式报警系统指南
发布日期: 2014-12-16
IEC TR 80001-2-5:2014(E)是一份技术报告,为责任组织、医疗器械制造商和其他信息技术供应商提供了应用IEC 80001-1:2010进行分布式报警系统风险管理的指导和实用技术。本技术报告适用于在至少一个源是医疗设备且至少一条通信路径使用医疗IT网络的情况下,在源、集成商和通讯器之间传输报警条件。本技术报告提供了从一个或多个来源整合、沟通响应和重定向(至另一个操作员)警报条件的建议,以确保安全性和有效性。 数据和系统安全是分布式报警系统风险管理的重要考虑因素。
IEC TR 80001-2-5:2014(E) which is a technical report, gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This technical report applies to the transmission of alarm conditions between sources, integrator and communicators where at least one source is a medical device and at least one communication path utilizes a medical IT-network. This technical report provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety and effectiveness. Data and systems security is an important consideration for the risk management of distributed alarm systems.
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归口单位: TC 62/SC 62A
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