IVD Design
EN ISO 17511
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
EN ISO 18153
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
EN ISO 20776-1
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
EN 61326-2-6
Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment