Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2: 2019).
Tests not accredited in our laboratory.
Tests with the Certificate of Good Laboratory Practices (GLPs).
ISO 11737-2: Part 2 of the standard specifies the general criteria for the sterility tests of medical devices that have been exposed to treatment with the sterilizing agent reduced compared to that expected to be used in the process of regular sterilization. These tests should be performed when defining, validating, or maintaining a sterilization process. This standard does not apply to sterility tests for the usual marketing of a product subjected to sterilization or to the performance of a sterility test. The cultivation is carried out from the products. Generally, a type of culture medium for the growth of microorganisms is used that is optimal for the cultivation of facultative aerobic microorganisms that might survive exposure to the sterilizing agent.
Samples or SIPs should be randomly selected. The manufacturer is responsible for determining the sample/SIP to be tested, the number of samples per lot, and the lots to be used for validation of the sterilization process.