Standard: ISO 11737-1 – “Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products.”
- Membrane filtration
- Plate-count (pour-plate method) are used to measure the number of microbes in a sample
- Test method validation shell be performed for each medical device or product family
- For validation purpose 11 sterile devices
- For routine analysis not sterile devices acc. to customer requirements [exp. 10 devices]
- Use a sample size of 10 devices/items for routine monitoring of bioburden levels – every quarter as minimum
If necessary we can perform the Identification of Microorganisms.