ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
1 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.
2 This part of ISO 11737 is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performance of a pharmacopoeial test for sterility; or
NOTE 1 The performance of a) or b) above is not a requirement of ISO 11134, 11135 or 11137.
c) culturing of biological indicators, including inoculated products.
NOTE 2 Methods of culturing biological indicators are described in ISO 11138.
ISO 11737-2:1998 history
2019ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
2009ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
1998ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process