GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process

Scope

This part of GB/T 19973 specifies the general standards for conducting sterility tests on medical devices that have been treated with disinfectants at a lower level than conventional sterilization. These tests are intended to be carried out during the definition, validation, or maintenance of the sterilization process.
This part does not apply to:
a) Sterility checks on products that have undergone a sterilization process during routine release;
b) Conducting sterility tests (see 3.12);
Note 1: Performing a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937, or ISO 17665-1.
c) Cultivation of biological indicators or inoculated products.

Development Information

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Superseded by the following standards

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