GB 18279-2023: Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

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Scope

This document specifies the development, validation and routine control requirements
for the ethylene oxide sterilization process during the manufacturing process of medical
device products. It is applicable to medical devices sterilized by ethylene oxide.

Basic Data

Standard ID	GB 18279-2023 (GB18279-2023)
Description (Translated English)	Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	58,526
Date of Issue	2023-09-08
Date of Implementation	2026-10-01
Older Standard (superseded by this standard)	GB 18279.1-2015,GB/T 18279.2-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration