BS EN IEC 80001-1:2021 - Page 2

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 | Status: Current, Under review

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.