PD ISO/TR 80001-2-6:2014 PDF
Application of risk management for IT-networks incorporating medical device - Application guidance. Guidance for responsibility agreements
Application of risk management for IT-networks incorporating medical device - Application guidance. Guidance for responsibility agreements
- Статус документа:
- D
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 ноября 2014 г.
- ICS:
- 11.040.01
- SKU:
- PD ISO/TR 80001-2-6:2014
Abstract
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 .
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