ISO 11737-2 specifies the general criteria for tests of sterility on medical devices. These tests are intended to be performed when defining, validating or maintaining a sterilization process. A sterile medical device is one that is free from viable microorganisms. Medical devices can, prior to sterilization, have microorganisms on them. Which means such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants.
The standards for quality management systems recognise that, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process is monitored routinely and the equipment is maintained.
ISO 11737-2 gives guidance on tests of sterility performed in the validation and maintenance of a sterilization process. It is not meant to be used for sterility testing for routine release of a product that has been subjected to a sterilization process, performing a test for sterility test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity or culturing of biological indicators or inoculated products. The international standard has been approved in Europe as EN ISO 11737-2:2020 without any changes and it supersedes EN ISO 11737-2:2009.
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