3European Union. Directive 98/79/EC of the european parliament and of the council of vitro diagnostic medical devices[J] European Communities, 1998, L331 27 october 1998 on in Official Journal of the 1237.
4ISO, In vitro diagnostic medical devices measurement of quantities in samples of biological origin-metrological traceability of values assigned to calibrators and control materials[S]. ISO/DIS 17511, Geneva, 2000.
5ISO, In vitro diagnostic medical devices measurement of quantities in samples of biological origin metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials[S]. ISO/DIS 18153, Geneva, 2000.
