English summary · Translation available

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

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

GB 18279-2023 is an upcoming mandatory Chinese national standard for Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Oct 1, 2026.

Applicability depends on product scope, certification route, competent authority notices and transition rules. Request a translation or verify source before using this record in a compliance decision.