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Sterilization of health care products—Radiation—Part 1: Requirements for the development,validation and routine control of a sterilization process for medical devices

医疗产品灭菌 辐射 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求

GB 18280.1-2025 is an upcoming mandatory Chinese national standard for Sterilization of health care products—Radiation—Part 1: 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 Jan 1, 2029.

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.