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

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Scope

1.1 This document specifies the general criteria for tests of sterility on medical devices
that have been exposed to a treatment with the sterilizing agent at levels lower than
those normally used in sterilization processes. This document is applicable to the
definition, validation or maintenance of a sterilization process.
1.2 This document is not applicable to.
a) test for sterility of sterilized products prior to routine release;
b) implementation of test for sterility (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 tests referred to in a) or
b).
c) test for sterility or test of sterility for demonstration of product shelf life,
stability and/or package integrity;
d) culturing of biological indicators or inoculated products.
Note 2.ISO 11138-7 provides guidance on culturing biological indicators.

Basic Data

Standard ID	GB/T 19973.2-2025 (GB/T19973.2-2025)
Description (Translated English)	Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	18,110
Date of Issue	2025-01-24
Date of Implementation	2026-02-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration