Historical
BS EN ISO 11737-2:2000
Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the validation of a sterilization process (British Standard)
This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which 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 validating a sterilization process.
This part of ISO 11737 is not applicable to:
- sterility testing for routine release of product that has been subjected to a sterilization process;
- performance of a pharmacopoeial test for sterility; or
- culturing of biological indicators, including inoculated products.
CONTENT PROVIDER
British Standards Institution [bsi]
British Standards Institution [bsi]