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Commission Directive 2005/61/ECShow full title
Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)
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PART B
Serious adverse reactions — imputability levels
| Imputability levels to assess serious adverse reactions. | ||
| Imputability level | Explanation | |
|---|---|---|
| NA | Not assessable | When there is insufficient data for imputability assessment. |
| 0 | Excluded | When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes. |
| Unlikely | When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components. | |
| 1 | Possible | When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes. |
| 2 | Likely, Probable | When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component. |
| 3 | Certain | When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component. |
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