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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| GB 18279-2023 |
Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of medical device sterilization processes {译} 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 |
China National Standards development,validation |
 English PDF |
| GB/T 19974-2018 |
Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌过程的开发、确认和常规控制的通用要求 |
China National Standards development,validation |
English PDF |
| GB 18280.1-2015 |
Sterilization of health care products—Radiation—Part 1：Requirements for development，validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌 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 |
China National Standards development,validation |
English PDF |
| GB 18279.1-2015 |
Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求 |
China National Standards development,validation |
English PDF |
| GB 18278.1-2015 |
Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、确认和常规控制要求 |
China National Standards development,validation |
English PDF |
| GB/T 19974-2005 |
Sterilization of health care products -- General requirement for characterization of a sterilizing agent and the development ,validation and routine control of a sterilization process for medical devices 医疗保健产品灭菌 灭菌因子的特性及医疗器械灭菌工艺的设定、确认和常规控制的通用要求 |
China National Standards development,validation |
English PDF |
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