Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

This report provides guidance on implementing responsibility agreements, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a medical device into an IT network in order to support compliance with IEC 80001-1. Stakeholders may include responsible organisations, IT suppliers, medical device manufacturers and others. The goal of the responsibility agreement is that these roles and responsibilities should cover the complete lifecycle of the resulting medical IT network.

Main sections:

· Scope

· Normative references

· Terms and definitions

· Key aspects for responsibility agreements

· Elements of a responsibility agreement

· Annex A: RACI chart

· Annex B: Typical documents