ISO 11737-2 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process
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ISO 11737-2 Document Information:
Title
Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process
International Organization for Standardization
Publication Date:
Jul 1, 1998
Scope:
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:
a) sterility testing for routine release of product that has been subjected to a sterilization process;
b) performance of a pharmacopoeial test for sterility; or
NOTE 1 The performance of a) or b) above is not a requirement of ISO 11134, 11135 or 11137.
c) culturing of biological indicators, including inoculated products.
NOTE 2 Methods of culturing biological indicators are described in ISO 11138.
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