Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

This document specifies general requirements for organisations in the application of risk management before, during and after the connection of a health IT system within a health IT infrastructure.

IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an organisation in the application of risk management; c) communication of the value, intention and purpose of risk management.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Principles

· Framework

· Risk management process