GB/T 18281.4-2024: Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat 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 sterilizers and sterilization processes
use dry hot air with a sterilization temperature range of 120 C ~ 180 C.
NOTE 1.for validation and routine control of dry heat sterilization processes, see ISO 20857.
NOTE 2.for workplace safety, refer to relevant national or regional regulations.

Basic Data

Standard ID	GB/T 18281.4-2024 (GB/T18281.4-2024)
Description (Translated English)	Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	14,162
Date of Issue	2024-11-28
Date of Implementation	2025-12-01
Older Standard (superseded by this standard)	GB 18281.4-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration