Table 1. Software risk management in healthcare applications: Some international standards of software risk management system [3].

No	Standards	Category	Description
IEC 60601-1	Risk manangement standard	Safety and essential performance of medical electrical equipment	This is the basic standard that refers to the minimum safety and performance required of a medical device before it can be sold.
IEC 61025	Functional safety standard	Applied to safety related systems that include electric/electronic systems installed in production	Describes fault tree analysis and provides guidance on its application to perform an analysis, identifies appropriate assumptions, events and failure modes, and provides identification rules and symbols.
ISO/IEC/IEEE 1633	Software failure modes, software reliability	Software quality and management software engineering	This standard provides guidance on the application of FTA to computer-based systems. It includes guidance on how to identify and analyses failure events, how to develop fault trees, and how to interpret the results of the analysis.
ISO 1497	Risk management	Application of risk management	Defines several risk management.