Table 4 Example of risk categories. Semi-quantitative (with respect to probability levels) respectively qualitative (with respect to severities) classification of risks in medical devices as proposed in [9]
From: Risk-based evaluation of machine learning-based classification methods used for medical devices
Levels regarding probability (likelihood) of risks | Levels regarding severity of risks |
|---|---|
frequent:\(\:\ge\:{10}^{-3}\) | negligible |
\(\:\text{probable}:\:<{10}^{-3}\:\text{and}\:\ge\:{10}^{-4}\) | minor |
\(\:\text{occasional}:\:<{10}^{-4}\:\text{and}\:\ge\:{10}^{-5}\) | serious / major |
\(\:\text{remote}:\:<{10}^{-5}\:\text{and}\:\ge\:{10}^{-6}\) | critical |
improbable:\(\:<{10}^{-3}\) | catastrophic / fatal |