Microbiological controls on Medical Devices

Mérieux NutriSciences provides a comprehensive range of microbiological services relating to medical devices, to support facility and product monitoring, as well as product development and registration.

Our microbiology facilities are equipped with clean rooms and biosafety level 2 and level 3 laboratories and our expert staff performs a wide range of tests, including:

• Microbiological tests: Bioburden, TAMC Total Aerobic Microbial Count, TYMC Total Yeast and Mould Count, patogens – UNI EN ISO 11737-1
• Microorganism identification – MALDI – TOF and DNA sequencing
• Sterilization test – UNI EN ISO 11737-2
• Sterilization validation service – UNI EN ISO 11737-2 e PHEUR 2.6.1
• Bacterial endotoxins detection – PHEUR 2.6.14
• Challenge test
• Environmental monitoring – EN 1484 e UNI EN ISO 9377-2