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AAMI/ISO TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements
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Assoc. for the Advancement of Medical Instrumentation Logo

AAMI/ISO TIR80001-2-6:2014

Application of risk management for IT-networks incorporating medical—Application guidance—Part 2-6: Guidance for responsibility agreements

PUBLISH DATE 2016
AAMI/ISO TIR80001-2-6:2014
Provides guidance for stakeholders on implementing RESPONSIBILITY AGREEMENTS 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 ANSI/80001-1. The goal of the RESPONSIBILITY AGREEMENT is that these roles and responsibilities should cover the complete lifecycle of the resulting MEDICAL IT-NETWORK.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR80001-2-6
Publication Date May 1, 2016
Language en - English
Page Count
Revision Level
Supercedes
Committee
Publish Date Document Id Type View
May 1, 2016 Revision