Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
|Publication Date:||15 November 2009|
|ICS Code (Medical microbiology):||07.100.10|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
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.
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);
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 14161.