GB18280.1-2025

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. Requst for the translation or verify source before using this record in a compliance decision.