Standard: ISO 11737-1 – “Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products.”

Method:

• Membrane filtration
• Plate-count (pour-plate method)  are used to measure the number of microbes in a sample

Requirements:

• 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.