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
Мы хотим включить аналитику посещений, чтобы понимать, что искать людям на сайте. Без вашего согласия счётчики не загружаются. Политика конфиденциальности
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 .
Упомянутые в описании и другие стандарты PD