Abstract: This technical specification 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. Elements not to be covered include areas already covered by existing or planned standards, e.g., alarms, human factors engineering, networking, etc. (80002-1).  Identical to IEC/TR 80002-1