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AAMI 11737-2
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AAMI 11737-2 2009 Edition, January 1, 2009 Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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Description / Abstract:
This part of ISO 11737 specifies the general criteria for tests
of sterility on medical devices that have been exposed to a
treatment with the sterilizing agent reduced relative to that
anticipated to be used in routine sterilization processing. These
tests are intended to be performed when defining, validating or
maintaining 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) performing a test for sterility (see 3.12);
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 14161[8].
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) performing a test for sterility (see 3.12);
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 14161[8].