1.1 This document 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 document 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), and NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7[5].