Performance evaluation of in vitro diagnostic medical devices not-for-sale Rehearsing an IT Service Continuity

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Performance evaluation of in vitro diagnostic medical devices not-for-sale Rehearsing an IT Service ContinuityBS EN 13612: 2002 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 apply to specific evaluation plans for certain IVD MDs or a specific use. NOTE For a selection of publications on specific