scope:

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:

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.