ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
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.
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1 Scope
1.1 Purpose
1.2 Prerequisites
2 Normative references
3 Terms and definitions
4 Key aspects for responsibility agreements
4.1 Reasons and rationale
4.2 Participants
4.3 Proposed types of responsibility agreements
4.4 Communication control
4.4.1 Bilateral versus multilateral responsibility agreements
4.4.2 Non-disclosure agreements
4.4.3 Update of information and documentation
4.5 Responsibility for establishing
4.6 Methods for determination and of responsibilities
4.7 Life cycle considerations
5 Elements of a responsibility agreement
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1 Scope
1.1 Purpose
1.2 Prerequisites
2 Normative references
3 Terms and definitions
4 Key aspects for responsibility agreements
4.1 Reasons and rationale
4.2 Participants
4.3 Proposed types of responsibility agreements
4.4 Communication control
4.4.1 Bilateral versus multilateral responsibility agreements
4.4.2 Non-disclosure agreements
4.4.3 Update of information and documentation
4.5 Responsibility for establishing
4.6 Methods for determination and of responsibilities
4.7 Life cycle considerations
5 Elements of a responsibility agreement