IEC/TR 80001-2-5:2014

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

Publication date:   Dec 17, 2014

General information

60.60 Standard published   Dec 17, 2014

IEC

ISO/TC 215 Health informatics

Technical Report

35.240.80   IT applications in health care technology | 11.040.01   Medical equipment in general

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Scope

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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PUBLISHED
IEC/TR 80001-2-5:2014
60.60 Standard published
Dec 17, 2014