Risk estimation

Risk estimation can be qualitative or quantitative, and the scales used for probability and severity are defined in the risk management plan. The values only mean something when they are applied the same way across the analysis.

process (3.14) used to assign values to the probability of occurrence of harm (3.3) and the severity (3.27) of that harm [SOURCE: ISO/IEC Guide 63:2019, 3.13]

ISO 14971:2019, clause 3.22

PROCESS used to assign values to the probability of occurrence of HARM and the severity of that HARM [SOURCE: ISO 14971:2007 2.20]

IEC 62304:2006+AMD1:2015, clause 3.39