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现行 AAMI/IEC TIR80001-2-5:2014
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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: 2014-12-24
本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南和实用技术。本技术报告适用于源、集成商和接收器之间的报警条件传输,其中至少一个源是医疗设备,并且至少一条通信路径使用医疗IT网络。它为一个或多个来源的报警条件的集成、响应通信和重定向(向另一个操作员)提供建议,以确保安全性、有效性以及数据和系统安全。
This 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 receivers where at least one source is a medical device and at least one communication path utilizes a medical IT-network. It provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety, effectiveness and data and systems security.
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