NEN - NPR-ISO/TR 80001-2-6
Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 January 2015 |
| Status: | active |
| Page Count: | 25 |
| ICS Code (IT applications in health care technology): | 35.240.80 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
NPR-ISO/TR 80001-2-6 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.
Document History
NPR-ISO/TR 80001-2-6
January 1, 2015
Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
NPR-ISO/TR 80001-2-6 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...