ABSTRACT
This chapter presents various important aspects of medical and mining system safety. Over the years, government and other agencies have placed various types of, directly or indirectly, safety-related requirements on medical devices. These requirements may be categorized under the following three areas safe design, safe function and sufficient information. Experiences over the years clearly indicate that in order to have safe medical devices/systems, safety has to be considered throughout their entire life cycle. Operating Hazard Analysis (OHA) is a method that particularly focuses on hazards occurring from tasks/activities for operating system functions that take place as the system is used, transported, or stored. Human error analysis is considered quite useful for highlighting hazards prior to their occurrence in the form of accidents. Management oversight and risk tree (MORT) analysis is an effective safety assessment method that can basically be applied to any safety-related program in the area of mining, and it first appeared in 1973.
