Some key points of ISO 14971:
RISK – combination of the probability of occurrence of harm and the severity of that harm
HAZARD – potential source of harm
HAZARDOUS SITUATION – circumstance in which people, property, or the environment are exposed to one or more hazard(s)
HARM – physical injury or damage to the health of people, or damage to property or the environment
SEVERITY – measure of the possible consequences of a hazard
RISK ANALYSIS – systematic use of available information to identify hazards and to estimate the risk
RISK ESTIMATION – process used to assign values to the probability of occurrence of harm and the severity of that harm
RISK EVALUATION – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk
RISK ASSESSMENT – overall process comprising a risk analysis and a risk evaluation
RISK CONTROL – process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels
RESIDUAL RISK – risk remaining after risk control measures have been taken