RiskEvaluation

1.Involves assessing the significance (and sometimes the acceptability) of the estimated risks. It may use risk criteria or cost-benefit analysis of possible risk reduction measures to show whether the risks are as low as reasonably practicable. This is the final stage in a risk assessment. [10]

2.General process involving risk analysis and risk evaluation. [5]

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Sources
5. DIN2001 DIN EN ISO 14971: 2001-03: Medizinprodukte – Anwendung des Risikomanagements auf Medizinprodukte. Beuth Verlag Berlin, 2001.
10. ARF Document The exact reference is not provided.

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