NS EN ISO 11737-2 : 2009

1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection and preparation of product units for
      testing
6 Tests of sterility
7 Assessment of method for test of sterility
Annex A (informative) Guidance on tests of sterility
                      performed in validation of a
                      sterilization process
Bibliography

Establishes the general requirements for tests on medical devices that 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 carried out when validating a sterilization process. Does not apply to sterility testing for routine release of product that has been subjected to a sterilization process, nor to performance of a pharmacopoeial sterility test.