PD ISO/TR 80001-2-6:2014

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 medical IT-network .