GB/T 18281.2-2024: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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Scope

This Document specifies the requirements and test methods for test microorganisms, bacterial
suspensions, contaminated carriers, and biological indicators to be used in evaluating the
performance of sterilizers and sterilization processes. The sterilizer and sterilization process use
pure ethylene oxide gas or a mixture of ethylene oxide gas and dilution gas, with a sterilization
temperature range of 29 °C to 65 °C.
NOTE 1.Requirements for validation and control of ethylene oxide sterilization are found in ISO 11135
and ISO 14937.
NOTE 2.Some national or regional regulations may specify workplace safety requirements.

Basic Data

Standard ID	GB/T 18281.2-2024 (GB/T18281.2-2024)
Description (Translated English)	Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	10,126
Date of Issue	2024-11-28
Date of Implementation	2025-12-01
Older Standard (superseded by this standard)	GB 18281.2-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration