AAMI/IEC TIR80002-1:2009 (PDF)
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This technical document provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices - Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software—Software life cycle processes.
Date of Publication: 26 October 2009