The microbiological evaluation with the usage of a partial cycle method is conducted in a microbiological laboratory and a validation cycle is in accordance with the PN-EN ISO 11135-1:2009 norm. This evaluation is to show the effectiveness of the sterilization process when it comes to ensuring needed probability of micro-organisms survival at the SAL level 10-6. The validation of sterilization process is conducted each time before launching a new medical device on the market.
Microbiological indicators in accordance with PN-EN ISO 11138-1 2:2008 and PN-EN ISO 11138-1 2:2009 are used in the routine process of sterilization. They contain microorganisms cultures that are characterized by the biggest immunity to the particular sterilizing indicator. In the case of sterilization with ethylene oxide, the spore population of Bacillus atrophaeus is used.