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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. 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 - 英文版 |
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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. 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 - 英文版 |
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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. 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 - 英文版 |
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GB/T 42080.2-2022 Molecular In vitro diagnostic tests - Specification of pre-examination procedures for frozen tissues - Part 2: Isolation of proteins 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 - 英文版 |
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GB/T 42080.1-2022 Molecular In vitro diagnostic tests - Specification of preexamination procedures for frozen tissues - Part 1: Isolation of RNA 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 - 英文版 |
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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 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 - 英文版 |
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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 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 - 英文版 |
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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 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 - 英文版 |
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GB/T 42218-2022 Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users 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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry 临床化学体外诊断试剂（盒） - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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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 - 英文版 |
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