Sterilization of medical devices. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Sterilization of medical devices. Microbiological methods - Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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1   Scope

This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.