ISO 11737-2:1998, Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process

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. This title may contain less than 24 pages of technical content.