Testing of medical devices

Determination of the population of microorganisms on products (bioburden) in accordance with DIN EN ISO 11737-1

Sterility testing according to DIN EN ISO 11737-2
Tests for sterility are performed in accordance with the EC Guide to Good Manufacturing Practice and Ph. Eur. under a Class A biological safety cabinet in a Class B clean room.

Testing for bacterial endotoxins (BET) according to Ph. Eur.

  • Kinetic-turbidimetric method

Testing of sterilisable packaging material