Sterility tests performed after medical devices are subjected to sterilization process by different methods, and control of the accuracy of the sterilization process is ensured.
If there is reproduction at the end of the test, the sterilization process should be reviewed.
Sterility analyses are carried out according to the following standards.
TS EN ISO 11737-2-Sterilization of medical devices – Microbiological methods – Part 2: Sterility experiments carried out in the description, validation and maintenance of a sterilization process
European Pharmacopeiae (E.P) 2.6.1-Sterility
USP 38 NF 33 (85)