Risk evaluation

The criteria come from the risk management plan and have to be set before the evaluation, not adjusted to fit the result. A risk judged not acceptable goes to risk control.

process (3.14) of comparing the estimated risk (3.18) against given risk (3.18) criteria to determine the acceptability of the risk (3.18) [SOURCE: ISO/IEC Guide 63:2019, 3.14]

ISO 14971:2019, clause 3.23

process of comparing the estimated RISK against given RISK criteria to determine the acceptability of the RISK [SOURCE: ISO/IEC Guide 63:2012, 2.14]

IEC 82304-1:2016, clause 3.17

PROCESS of comparing the estimated RISK against given RISK criteria to determine the acceptability of the RISK [SOURCE: ISO 14971:2007 2.21]

IEC 62304:2006+AMD1:2015, clause 3.40