DIN EN ISO 17511:2003-11

This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. Control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility, are outside the scope of this European Standard.