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Risk Analysis


Risk analyses are not only established in order to comply with the requirements of authorities (e.g. Council directive 93/42/EEC concerning medical devices). Risk analyses already assist the manufacturer at development stage to recognize a possible hazard potential and to master it through proper actions.

Risk means the probability of occurrence times the effects of a possible hazard. A careful collection of


potential hazards is needed. It is mandatory to remove excessive risks. Residual risks, which could not further be removed but which could be considered acceptable, require adequate information (e.g. package insert).

If none normative obligation is given (as per e.g. EN1441 Medical devices Risk analysis), it may still be helpful to establish at least a quantitative risk analysis (see below).