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ISO TR 80001-2-6:2014 ED1

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
20. 11. 2014.

Опште информације

60.60     5. 12. 2014.

IEC

TC 62/SC 62A

Технички извештај

11.040.01     35.240.80  

енглески  

Куповина

Објављен

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Апстракт

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.

Животни циклус

ТРЕНУТНО

ОБЈАВЉЕН
ISO TR 80001-2-6:2014 ED1
60.60 Стандард објављен
5. 12. 2014.