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
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.