7The European Parliament and The Council of the EU. In vitro diagnostic medical devices [S:. Directive 98 ! 79 ! EC of the European Parliament and the Council, 1998.
8ISO. In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Metrological traceabi- lity of values assigned to calibrators and control materials IS]. ISO / CD 17511 2003. 2003-08-01.
9ISO. In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Metrological traceabi- lity of values for catalytic concentration of enzymes assigned to calibrators and control materials IS]. ISO/CD 18153 2003. 2003-08-01.
