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AAMI/IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices—Part 2-5: Application guidance—Guidance for distributed alarm systems

Summary

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. Annex 3

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2014
Page Count 47
Themes IT, Software, and Wireless
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ISBN ---
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