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Content DescriptionIEC 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.About IECThe IEC is a global, not-for-profit membership organization, whose work underpins quality infrastructure and international trade in electrical and electronic goods. The IEC facilitates technical innovation, affordable infrastructure development, efficient and sustainable energy access, smart urbanization and transportation systems, climate change mitigation, and increases the safety of people and the environment.
The IEC brings together ~170 countries and provides a global, neutral and independent standardization and conformity assessment platform for 30 000 experts globally. It administers 4 Conformity assessment systems whose members certify that devices, systems, installations, services and people work as required.
The IEC publishes around 10 000 IEC International Standards which together with conformity assessment provide the technical framework that allows governments to build national quality infrastructure and companies of all sizes to buy and sell consistently safe and reliable products in most countries of the world. IEC International Standards serve as the basis for risk and quality management and are used in testing and certification to verify that manufacturer promises are kept. |
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