Risk assessment

In ISO 14971 risk assessment covers identifying and estimating risk and then judging it against the acceptability criteria in the risk management plan. Risk control comes after it, for the risks that are not acceptable.

overall process (3.14) comprising a risk analysis (3.19) and a risk evaluation (3.20) [SOURCE: ISO/IEC Guide 51:2014, 3.11]

ISO 14971:2019, clause 3.20

overall process comprising a RISK ANALYSIS and a RISK EVALUATION [SOURCE: ISO/IEC Guide 51:2014, 3.11]

IEC 82304-1:2016, clause 3.15