GB/T 18281.3-2024: Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

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Scope

This document specifies the requirements for test microorganisms, bacterial suspensions,
contaminated carriers, biological indicators and test methods intended for evaluating the
performance of moist heat as a sterilization factor in the sterilization processes.
NOTE 1.requirements for validation and routine control of moist heat sterilization are given in
ISO 17665.
NOTE 2.regulations in some countries or regions may have provided the safety requirements for
workplaces.

Basic Data

Standard ID	GB/T 18281.3-2024 (GB/T18281.3-2024)
Description (Translated English)	Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	14,141
Date of Issue	2024-11-28
Date of Implementation	2025-12-01
Older Standard (superseded by this standard)	GB 18281.3-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration