Risk analysis

Risk analysis is the first half of risk assessment: it lists what could go wrong and how likely and severe the harm would be. Deciding whether that risk is acceptable is a separate step, risk evaluation.

systematic use of available information to identify hazards (3.4) and to estimate the risk (3.18) [SOURCE: ISO/IEC Guide 63:2019, 3.11]

ISO 14971:2019, clause 3.19

systematic use of available information to identify HAZARDS and to estimate the RISK [SOURCE: ISO/IEC Guide 51:2014, 3.10]

IEC 82304-1:2016, clause 3.14

systematic use of available information to identify HAZARDS and to estimate the RISK [ISO 14971:2007, 2.17]

IEC 62304:2006+AMD1:2015, clause 3.17