ISO TR 80001-2-6
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.
CHF 96.-
Technical committee
TC 62/SC 62A Common aspects of medical equipment, software, and systems| Publication type | Technical Report |
| Publication date | 2014-11-20 |
| Edition | 1.0 |
| ICS | 11.040.01 35.240.80 |
| Stability date | 2024 |
| Pages | 15 |
| File size | 229.50 KB |
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