In vitro-diagnostik - Statistisk acceptanskontroll för in vitro-diagnostiska medicintekniska produkter - Statistiska överväganden

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.