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| Standard Code | Standard Title | Standard Class | Order |
|---|---|---|---|
| GB/Z 42217-2022 |
Medical devices for the validation of medical device quality system software {译} 医疗器械 用于医疗器械质量体系软件的确认 |
China National Standards Medical devices 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 Medical devices Validation |
English PDF |
| GB/T 19973.2-2018 |
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process 医疗器械的灭菌 微生物学方法 第2部分：用于灭菌过程的定义、确认和维护的无菌试验 |
China National Standards Medical devices 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 Medical devices 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 Medical devices 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 Medical devices Validation |
English PDF |
| GB/T 19633.2-2015 |
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes 最终灭菌医疗器械包装 第2部分：成形、密封和装配过程的确认的要求 |
China National Standards Medical devices 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 Medical devices Validation |
English PDF |
| GB/T 19973.2-2005 |
Sterilization of medical devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process 医用器材的灭菌 微生物学方法 第二部分：确认灭菌过程的无菌试验 |
China National Standards Medical devices Validation |
English PDF |
| GB 18279-2000 |
Medical devices--Validation androutine control of ethylene oxide sterilization 医疗器械 环氧乙烷灭菌 确认和常规控制 |
China National Standards Medical devices Validation |
English PDF |
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