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 sterilization |
English PDF |
GB/T 42525-2023 |
Technical Specifications for Microfiltration Membrane sterilization and Filtration System {译} 微滤膜除菌过滤系统技术规范 |
China National Standards sterilization |
English PDF |
GB/T 19973.1-2023 |
sterilization of healthcare products - Microbiological methods - Part 1: Determination of the total number of microorganisms on a product {译} 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 |
China National Standards sterilization |
English PDF |
GB/T 40449-2021 |
Technical specification of canine and feline sterilization operation 犬、猫绝育手术操作技术规范 |
China National Standards sterilization |
English PDF |
GB/T 39948-2021 |
Method of heat distribution test for food thermal sterilization equipments 食品热力杀菌设备热分布测试规程 |
China National Standards sterilization |
English PDF |
GB/T 15981-2021 |
Evaluating method for the efficacy of sterilization for disinfection equipment 消毒器械灭菌效果评价方法 |
China National Standards sterilization |
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 sterilization |
English PDF |
GB/T 19972-2018 |
sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results 医疗保健产品灭菌 生物指示物 选择、使用和结果判断指南 |
China National Standards sterilization |
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 sterilization |
English PDF |
GB/T 36036-2018 |
Verify guidance of cleaning and sterilization for pharmaceutical machinery 制药机械(设备)清洗、灭菌验证导则 |
China National Standards sterilization |
English PDF |
GB/T 33418-2016 |
Test method of chemical indicator for ethylene oxide sterilization processes 环氧乙烷灭菌化学指示物检验方法 |
China National Standards sterilization |
English PDF |
GB/T 33417-2016 |
Test method of biological indicator for hydrogen peroxide vapour sterilization processes 过氧化氢气体灭菌生物指示物检验方法 |
China National Standards sterilization |
English PDF |
GB/T 33420-2016 |
Evaluation standard of biological for moist heat sterilization processes 压力蒸汽灭菌生物指示物检验方法 |
China National Standards sterilization |
English PDF |
GB/T 33419-2016 |
Test method of biological indicator for ethylene oxide sterilization processes 环氧乙烷灭菌生物指示物检验方法 |
China National Standards sterilization |
English PDF |
GB/T 18280.3-2015 |
sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects 医疗保健产品灭菌 辐射 第3部分:剂量测量指南 |
China National Standards sterilization |
English PDF |
GB 18280.2-2015 |
sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose 医疗保健产品灭菌 辐射 第2部分:建立灭菌剂量 |
China National Standards sterilization |
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 sterilization |
English PDF |
GB/T 18279.2-2015 |
sterilization of health care products—Ethylene oxide—Part 2: Guidance on the application of GB 18279.1 医疗保健产品的灭菌 环氧乙烷 第2部分:GB 18279.1应用指南 |
China National Standards sterilization |
English PDF |
GB/T 16886.7-2015 |
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量 |
China National Standards sterilization |
English PDF |
GB 18282.5-2015 |
sterilization of health care products—Chemical indicators—Part 5:Class 2 indicators for Bowie and Dick-type air removal tests 医疗保健产品灭菌 化学指示物 第5部分:用于BD类空气排除测试的二类指示物 |
China National Standards sterilization |
English PDF |
GB 18282.1-2015 |
sterilization of health care products—Chemical indicator—Part 1: General requirements 医疗保健产品灭菌 化学指示物 第1部分:通则 |
China National Standards sterilization |
English PDF |
GB 18281.5-2015 |
sterilization of health care products—Biological indicator—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes 医疗保健产品灭菌 生物指示物 第5部分:低温蒸汽甲醛灭菌用生物指示物 |
China National Standards sterilization |
English PDF |
GB 18281.4-2015 |
sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes 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 |
China National Standards sterilization |
English PDF |
GB 18281.3-2015 |
sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes 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 |
China National Standards sterilization |
English PDF |
GB 18281.2-2015 |
sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes 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 |
China National Standards sterilization |
English PDF |
GB 18281.1-2015 |
sterilization of health care products—Biological indicators—Part 1: General requirements 医疗保健产品灭菌 生物指示物 第1部分:通则 |
China National Standards sterilization |
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 sterilization |
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 sterilization |
English PDF |
GB/T 32310-2015 |
sterilization of health care products—Chemical indicators—Guidance for selection,use and interpretion of results 医疗保健产品灭菌 化学指示物 选择、使用和结果判断指南 |
China National Standards sterilization |
English PDF |
GB/T 19973.1-2015 |
sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products 医疗器械的灭菌 微生物学方法 第1部分:产品上微生物总数的测定 |
China National Standards sterilization |
English PDF |
GB/T 19971-2015 |
sterilization of health care products—Vocabulary 医疗保健产品灭菌 术语 |
China National Standards sterilization |
English PDF |
GB/T 31995-2015 |
sterilization of health care products—Radiation—Substantiation of a selected sterilization dose method VDmax 医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法 |
China National Standards sterilization |
English PDF |
GB/T 30690-2014 |
Monitoring requirements and evaluation of sterilization effect of small steam sterilizer 小型压力蒸汽灭菌器灭菌效果监测方法和评价要求 |
China National Standards sterilization |
English PDF |
GB 16383-2014 |
Quality control for radiation sterilization of medical and hygienical products 医疗卫生用品辐射灭菌消毒质量控制 |
China National Standards sterilization |
English PDF |
GB 18282.4-2009 |
sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration 医疗保健产品灭菌 化学指示物 第4部分:用于替代性BD类蒸汽渗透测试的二类指示物 |
China National Standards sterilization |
English PDF |
GB 18282.3-2009 |
sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test 医疗保健产品灭菌 化学指示物 第3部分:用于BD类蒸汽渗透测试的二类指示物系统 |
China National Standards sterilization |
English PDF |
GB/T 24628-2009 |
sterilization of health care products - Biological and chemical indicators - Test equipment 医疗保健产品灭菌 生物与化学指示物 测试设备 |
China National Standards sterilization |
English PDF |
GB/T 20367-2006 |
sterilization of health care products - Requirement for validation and routine control of moist heat sterilization in health care facilities 医疗保健产品灭菌 医疗保健机构湿热灭菌的确认和常规控制要求 |
China National Standards sterilization |
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 sterilization |
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 sterilization |
English PDF |
GB/T 19973.1-2005 |
sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products 医用器材的灭菌 微生物学方法 第一部分:产品上微生物总数的估计 |
China National Standards sterilization |
English PDF |
GB/T 19972-2005 |
sterilization of health care products -- Biological indicators --Guidance for the selection, use and interpretation of results 医疗保健产品灭菌 生物指示物 选择、使用及检验结果判断指南 |
China National Standards sterilization |
English PDF |
GB/T 19971-2005 |
sterilization of health care products -- Vocabulary 医疗保健产品灭菌 术语汇编 |
China National Standards sterilization |
English PDF |
GB/T 16886.7-2001 |
Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals 医疗器械生物学评价 第7部分:环氧乙烷灭菌残留量 |
China National Standards sterilization |
English PDF |
GB 18282.1-2000 |
sterilization of health care products--Chemical indicators--Part 1:General requirements 医疗保健产品灭菌 化学指示物 第1部分:通则 |
China National Standards sterilization |
English PDF |
GB 18281.3-2000 |
sterilization of health care products--Biological indicators--Part 3:Biological indicators for moist heat sterilization 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 |
China National Standards sterilization |
English PDF |
GB 18281.2-2000 |
sterilization of health care products--Biological indicators--Part 2:Biological indicators for ethylene oxide sterilization 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 |
China National Standards sterilization |
English PDF |
GB 18281.1-2000 |
sterilization of health care products--Biological indicators--Part 1:General 医疗保健产品灭菌 生物指示物 第1部分:通则 |
China National Standards sterilization |
English PDF |
GB 18280-2000 |
sterilization of healthcare products--Requirement for validation and routine control--Radiation sterilization 医疗保健产品灭菌 确认和常规控制要求 辐射灭菌 |
China National Standards sterilization |
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 sterilization |
English PDF |
GB 18278-2000 |
sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization 医疗保健产品灭菌 确认和常规控制要求 工业湿热灭菌 |
China National Standards sterilization |
English PDF |
GB 16352-1996 |
Standards for γ-rays radiation sterilization of disposable medical appliances 一次性医疗用品γ射线辐射灭菌标准 |
China National Standards sterilization |
English PDF |
GB 15981-1995 |
Evaluating method and standard for the efficacy of disinfection and sterilization 消毒与灭菌效果的评价方法与标准 |
China National Standards sterilization |
English PDF |
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