Historical

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; or
  • culturing of biological indicators, including inoculated products.


CONTENT PROVIDER
International Organization for Standardization [iso]

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