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ISO 11737-2:1998
M00009077
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ISO 11737-2:1998 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process
standard by International Organization for Standardization, 07/01/1998
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Full Description
This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices which have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when validating a sterilization process.
This part of ISO 11737 is not applicable to:
sterility testing for routine release of product that has been subjected to a sterilization process;performance of a pharmacopoeial test for sterility; orculturing of biological indicators, including inoculated products.