Stability testing of in vitro diagnostic reagents has-tracked-changes Required characteristics

Required characteristics

90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)

Requirements for this are

A group of medical electrical equipment (for example

Stability testing of in vitro diagnostic reagents has-tracked-changes Required characteristicsStability testing of in vitro diagnostic reagents Executive summary Stability testing of in vitro diagnostic reagents. Abstract This European Standard covers the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. This standard specifies general requirements for stability testing and gives specific requirements for real time testing and accelerated