RiskAnalysis

1.Is the quantification of risks without making judgements about their significance. It involves identifying hazards and estimating their frequencies and consequences, so that the results can be presented as risks. Sometimes, this is known as risk estimation or risk quantification. [10]

2.Risk analysis is a systematic evaluation of the information available, in order to identify hazards and measure risks. [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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