中華人民共和國國家標準(中國大陸GB標準)英文版 |
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GB 18279-2023 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(中英文版) Sterilization of healthcare products Ethylene oxide Requirements for the development, validation and routine control of medical device sterilization processes |
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GB/T 19973.1-2023 医疗保健产品灭菌 微生物学方法 第1部分:产品上微生物总数的确定(中英文版) Sterilization of healthcare products - Microbiological methods - Part 1: Determination of the total number of microorganisms on a product |
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YY 0970-2023 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求(中英文版) Sterilization of healthcare products - Liquid chemical sterilants for single-use medical devices of animal origin - Requirements for the characterization, development, validation and routine control of medical device sterilization processes |
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YY/T 1464-2022 医疗保健产品灭菌 低温蒸汽甲醛 医疗器械灭菌过程的开发、确认和常规控制要求(中英文版) Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes |
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GB/T 39948-2021 食品热力杀菌设备热分布测试规程(中英文版) Method of heat distribution test for food thermal sterilization equipments |
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GB/T 19972-2018 医疗保健产品灭菌 生物指示物 选择、使用和结果判断指南(中英文版) Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results |
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GB/T 19974-2018 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(中英文版) 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 |
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GB/T 33420-2016 压力蒸汽灭菌生物指示物检验方法(中英文版) Evaluation standard of biological for moist heat sterilization processes |
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YY/T 1276-2016 医疗器械干热灭菌过程的开发、确认和常规控制要求(中英文版) (Development of medical devices dry heat sterilization process, validation and routine control) |
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GB 18280.1-2015 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(中英文版) Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices |
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GB 18280.2-2015 医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量(中英文版) Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose |
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GB/T 18280.3-2015 医疗保健产品灭菌 辐射 第3部分:剂量测量指南(中英文版) Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects |
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GB/T 19971-2015 医疗保健产品灭菌 术语(中英文版) Sterilization of health care products—Vocabulary |
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GB 18281.2-2015 医疗保健产品灭菌 生物指示物 第2部分:环氧乙烷灭菌用生物指示物(中英文版) Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes |
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GB 18279.1-2015 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(中英文版) Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices |
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GB 18281.4-2015 医疗保健产品灭菌 生物指示物 第4部分:干热灭菌用生物指示物(中英文版) Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes |
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GB/T 32310-2015 医疗保健产品灭菌 化学指示物 选择、使用和结果判断指南(中英文版) Sterilization of health care products—Chemical indicators—Guidance for selection,use and interpretion of results |
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GB 18281.3-2015 医疗保健产品灭菌 生物指示物 第3部分:湿热灭菌用生物指示物(中英文版) Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes |
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GB 18278.1-2015 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(中英文版) Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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GB 18282.1-2015 医疗保健产品灭菌 化学指示物 第1部分:通则(中英文版) Sterilization of health care products—Chemical indicator—Part 1: General requirements |
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