Historical
ISO 11737-2:1998
Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
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
International Organization for Standardization [iso]
