China National Standards

China In vitro diagnostic GB Standards List

  •  China "In vitro diagnostic" GB Standards List:
    • Standard  Code Standard Title Standard Class Order
    GB/T 46943-2025 Clinical Laboratory Testing and In vitro diagnostic Systems - General Requirements for Performance Validation of High-Throughput Metagenomic Sequencing of Pathogens {译}
    临床实验室检测和体外诊断系统 - 病原宏基因组高通量测序性能确认通用要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 46454-2025 Clinical Laboratory Tests and In vitro diagnostic Systems - Reference Method for In Vitro Activity Testing of Antimicrobial Agents Against Yeast-Like Fungi Associated with Infectious Diseases Using Micro-Bouillon Dilution {译}
    临床实验室检测和体外诊断系统 - 感染性疾病相关酵母样真菌抗微生物药物的体外活性检测微量肉汤稀释参考方法    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 39367-2025 In vitro diagnostic Test Systems - Procedures for Detection and Identification of Pathogenic Microorganisms Based on Nucleic Acid Amplification - General Principles for Laboratory Quality Practices {译}
    体外诊断检测系统 - 基于核酸扩增的病原微生物检测和鉴定程序 - 实验室质量实践通则    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 21415-2025 In vitro diagnostic medical devices - Requirements for establishing the metrological traceability of calibration materials, accuracy control substances and human specimens {译}
    体外诊断医疗器械 - 建立校准品、正确度控制物质和人体样品赋值的计量溯源性要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 44827-2024 Molecular In vitro diagnostic tests - Specifications for pre-testing processes for urine, venous serum and plasma metabolomics {译}
    分子体外诊断检验-尿液、静脉血清和血浆代谢组学检验前过程的规范    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 44467-2024 Molecular In vitro diagnostic tests - Specifications for pre-saliva testing - Extraction of human DNA {译}
    分子体外诊断检验-唾液检验前过程的规范-提取人类DNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42080.3-2024 Molecular In vitro diagnostic test-Specifications for the pre-test process of frozen tissue-Part 3: DNA isolation {译}
    分子体外诊断检验-冷冻组织检验前过程的规范-第3部分：分离DNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 44586.1-2024 In vitro diagnostic medical devices-Multiple nucleic acid molecular detection-Part 1: Nucleic acid quality evaluation terms and general requirements {译}
    体外诊断医疗器械-多重核酸分子检测-第1部分：核酸质量评价术语和通用要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 44672-2024 In vitro diagnostic medical devices - Establishment of calibration products and human samples Requirements for internationally consistent schemes for assigning metrological traceability {译}
    体外诊断医疗器械-建立校准品和人体样品赋值计量溯源性的国际一致化方案的要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42216.4-2024 Molecular In vitro diagnostic tests-Specifications for pre-test processes of formalin-fixed and paraffin-embedded tissues-Part 4: In-situ detection technology {译}
    分子体外诊断检验-福尔马林固定及石蜡包埋组织检验前过程的规范-第4部分：原位检测技术    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 43279.3-2023 Molecular In vitro diagnostic tests. Specification of pre-test procedures for venous whole blood. Part 3: Isolation of plasma circulating cell-free DNA. {译}
    分子体外诊断检验 静脉全血检验前过程的规范 第3部分：分离血浆循环游离DNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 43279.2-2023 Molecular In vitro diagnostic tests. Specification of pre-test procedures on venous whole blood. Part 2: Isolation of genomic DNA. {译}
    分子体外诊断检验 静脉全血检验前过程的规范 第2部分：分离基因组DNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 43279.1-2023 Molecular In vitro diagnostic tests. Specification of pre-test procedures for venous whole blood. Part 1: Isolation of cellular RNA. {译}
    分子体外诊断检验 静脉全血检验前过程的规范 第1部分：分离细胞RNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42080.2-2022 Molecular In vitro diagnostic tests - Specification of pre-examination procedures for frozen tissues - Part 2: Isolation of proteins {译}
    分子体外诊断检验 冷冻组织检验前过程的规范 第2部分：分离蛋白质    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42080.1-2022 Molecular In vitro diagnostic tests - Specification of preexamination procedures for frozen tissues - Part 1: Isolation of RNA {译}
    分子体外诊断检验 冷冻组织检验前过程的规范 第1部分：分离RNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42216.2-2022 Molecular In vitro diagnostic tests - Specification for pre-examination procedures of formalin-fixed and paraffin-embedded tissues - Part 2: Isolation of proteins {译}
    分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第2部分：分离蛋白质    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42216.3-2022 Molecular In vitro diagnostic tests - Specification for preexamination procedures of formalin-fixed and paraffin-embedded tissues - Part 3: Isolation of DNA {译}
    分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第3部分：分离DNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42216.1-2022 Molecular In vitro diagnostic tests - Specification for preexamination procedures of formalin-fixed and paraffin-embedded tissues - Part 1: Isolation of RNA {译}
    分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第1部分：分离RNA    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 42218-2022 Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users {译}
    检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19702-2021 In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
    体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19634-2021 In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
    体外诊断检验系统 自测用血糖监测系统通用技术条件    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 39367.1-2020 In vitro diagnostic test systems—Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens—Part 1: General requirements, terms and definitions
    体外诊断检验系统 病原微生物检测和鉴定用核酸定性体外检验程序 第1部分：通用要求、术语和定义    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
    体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 29791.5-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting
    体外诊断医疗器械 制造商提供的信息（标示） 第5部分：自测用体外诊断仪器    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 29791.4-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting
    体外诊断医疗器械 制造商提供的信息（标示） 第4部分：自测用体外诊断试剂    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 29791.3-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
    体外诊断医疗器械 制造商提供的信息（标示） 第3部分：专业用体外诊断仪器    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 29791.2-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
    体外诊断医疗器械 制造商提供的信息（标示） 第2部分：专业用体外诊断试剂    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 29791.1-2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
    体外诊断医疗器械 制造商提供的信息（标示） 第1部分：术语、定义和通用要求    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry
    临床化学体外诊断试剂（盒）    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 18268.26-2010 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment
    测量、控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断(IVD)医疗设备    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
    体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
    体外诊断医疗器械 生物源性样品中量的测量 参考物质的说明    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19702-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures
    体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的说明    		 China National Standards
    In vitro diagnostic
    English PDF
    GB/T 19634-2005 In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
    体外诊断检验系统 自测用血糖监测系统通用技术条件    		 China National Standards
    In vitro diagnostic
    English PDF

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