GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2:Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Scope

1.1 This document specifies the general standards to be followed when conducting sterility tests on medical devices that have been treated with sterilizing agents at doses lower than those typically used in sterilization processes. This document applies to the definition, validation, or maintenance of sterilization processes.
1.2 This document does not apply to:
a) Sterility inspections conducted on sterilized products prior to their routine release;
b) The implementation of sterility inspections (see 3.12);
Note 1: ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1, and ISO 20857 do not require the performance of the tests involved in a) or b).
c) Sterility inspections or sterility tests used to demonstrate the product's shelf life, stability, and/or packaging integrity;
d) The cultivation of biological indicators or inoculated products.
Note 2: ISO 11138-7 provides guidelines for the cultivation of biological indicators.

Development Information

Replace the following standards

Adopt standards

Related Standards