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Following the sterilization process of medical devices with different methods, tests are performed to check the accuracy of the sterilization process.

In case of any growth at the end of the test, the sterilization process should be reviewed.

Sterility analyses are performed according to the following standards.

TS EN ISO 11737-2-Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

European Pharmacopeiae(E.P) 2.6.1-Sterility

USP 38 NF 33 (85)