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ONORM EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices (Austrian Standard)
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.
Austrian Standards Institute [on]