1887956

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

standard by International Organization for Standardization (Technical Report) , 12/01/2014

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Full Description

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.

 

Product Details

Published:
12/01/2014
Number of Pages:
22
File Size:
1 file , 170 KB
Same As:
BS PD ISO/TR 80001-2-6:2014
Note:
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