PD ISO/TR 80001-2-6:2014

Application of risk management for IT-networks incorporating medical device. Application guidance. Guidance for responsibility agreements | Status: Current, Under review

1 Scope

1.1 Purpose

This Technical 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 to IEC 80001-1. Stakeholders may include responsible organizations, 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 medicalIT-network.