EVS-EN ISO 11737-2:2010

1.1  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. 1.2  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)  performing a test for sterility (see 3.12);