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DIN EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices
This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not give specific performance study protocols for single IVD MDs or a specific use.
Deutsches Institut für Normung [din]