Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed
in the definition, validation and maintenance of a sterilization process
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Specifies the general criteria for tests of sterility on medical devices that have been exposed to a
treatment with the sterilizing agent that is a fraction of the specified sterilization process. These
tests are intended to be performed when defining, validating or maintaining a sterilization process.