Standard

ISO/TR 80001-2-6:2014

Nov 2014 Current

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Language English

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Abstract

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.

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Standard from ISO
Published: November 20 2014
Edition: 1
Document type: TR
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.01
ICS: 35.240.80
International TC: ISO/TC 215

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Abstract

Products specifications

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