Guidelines for Risk Management and Analysis
This paper is to introduce guidelines for risk management and analysis. International tandards such as IEC 60300-3-9, IEC 61511-3, ISO 14971-1 and ISO/IEC Guide 73 are considered. This study is to discuss risk analysis of technological systems, and guidelines in the application of hazard and risk analysis for functional safety instrumented system, and risk management of medical devices, and guidelines for use in risk management standards.