Application of risk management for IT-networks incorporating medical devices - Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Application of risk management for IT-networks incorporating medical devices - Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

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1   Scope

This document specifies general requirements for organizations in the application of risk management before, during and after the connection of a health it system within a health it infrastructure, by addressing the key properties of safety, effectiveness and security whilst engaging appropriate stakeholders.