ISO/TR 80001-2-6:2014提供了实施责任协议的指南，IEC 80001-1中描述了责任协议，用于确定参与将医疗器械纳入IT网络的利益相关者之间的角色和责任，以支持遵守IEC 80001-1。利益相关者可能包括责任组织、IT供应商、医疗器械制造商和其他人。责任协议的目标是，这些角色和责任应涵盖由此产生的医疗IT网络的整个生命周期。

ISO/TR 80001-2-6:2014 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.