GB/T 24628-2025: Sterilization of health care products - Biological and chemical indicators - Test equipment

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Scope

This Document specifies the requirements for test equipment to be used to.
--- test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes
for conformity to the requirements given in GB/T 18281 (all parts);
--- test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen
peroxide sterilization processes for conformity to the requirements given in GB/T
18282.1-2025.
This Document also provides informative methods useful in characterizing the performance of
biological and chemical indicators for intended use and for routine quality control testing.
GB/T 18281.2-2024, GB/T 18281.3-2024, GB/T 18281.4-2024 and GB/T 18282.1-2025
require the use of resistometers specified in this document, and these resistometers are used in
conjunction with the test methods specified in the appropriate parts of GB/T 18281 (all parts)
and ISO 11140 (all parts).
This Document does not specify requirements for test equipment for processes specifically for
testing chemical and biological indicators intended to monitor isolator and room
biodecontamination processes at atmospheric pressure.
Resistometers for low temperature steam and formaldehyde indicators are not included in this
Document. Test methods using laboratory apparatus for low temperature steam and
formaldehyde are included in GB/T 18281.5-2024.
Test equipment for testing Type 2 (e.g. Bowie Dick) chemical indicators are specified in ISO
11140-3.2007, ISO 11140-4.2007, and ISO 11140-5.2007.

Basic Data

Standard ID	GB/T 24628-2025 (GB/T24628-2025)
Description (Translated English)	Sterilization of health care products - Biological and chemical indicators - Test equipment
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	34,332
Date of Issue	2025-01-24
Date of Implementation	2026-02-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration