BS EN ISO 11737-2:2009

Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Status: Superseded, Withdrawn

1 Scope 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.