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Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
Standard in brief
Scope of Application：
本文件规定了医疗器械产品在制造过程中环氧乙烷灭菌过程的开发、确认和常规控制要求，适用于采用环氧乙烷灭菌的医疗器械。
Basic information
Standard No：GB 18279-2023
Standard Name：医疗保健产品灭菌 环氧乙烷 医疗器械灭菌过程的开发、确认和常规控制要求
English Name：Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
Standard Status：To be implemented
Release Date： 2000-01-01
Effective Date：2026-10-01
Language of Publication：Simplified Chinese
Associated Standard
Replace the following standard： GB 18279.1-2015,GB/T 18279.2-2015
Quoted Standard：GB 18281.1-2015,GB 18281.2-2015,GB 18282.1
Publication Information
Number of pages：60
Number of words：116 K
Other Information
Technical Committees：国家药品监督管理局
Proposed Unit：国家药品监督管理局
Application Dept：国家市场监督管理总局、国家标准化管理委员会
