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.
Diese ÖNORM legt Anforderungen an Probenahmeverfahren für die Prüfungen fest, durch welche die Homogennität von Prozessen und Produkten nachgewiesen und kontrolliert wird. Diese ÖNORM gilt auch für die Erstellung von Stichprobenplänen für Fertigprodukte nach den Bestimmungen für Produktzertifizierungsprogramme und Qualitätsmanagementsysteme des Herstellers.