China National Standards

China In vitro diagnostic Industry Standards English PDF List

  •  China "In vitro diagnostic" Industry Standards English PDF List:
    • Standard  Code Standard Title Standard Class Order
    YY/T 1151-2009 Protein microarray chips for In vitro diagnostics {译}
    体外诊断用蛋白质微阵列芯片    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1153-2009 DNA microarray chips for In vitro diagnostics {译}
    体外诊断用DNA微阵列芯片    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.5-2023 In vitro diagnostic test systems - Performance evaluation methods - Part 5: Analytical specificity {译}
    体外诊断检验系统 性能评价方法 第5部分：分析特异性    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.6-2023 In vitro diagnostic test systems - Performance evaluation methods - Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents {译}
    体外诊断检验系统 性能评价方法 第6部分：定性试剂的精密度、诊断灵敏度和特异性    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.4-2022 In vitro diagnostic test systems - Performance evaluation methods - Part 4: Linear and reportable intervals {译}
    体外诊断检验系统 性能评价方法 第4部分：线性区间与可报告区间    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.3-2022 In vitro diagnostic test systems - Performance evaluation methods - Part 3: Limits of detection and limits of quantitation {译}
    体外诊断检验系统 性能评价方法 第3部分：检出限与定量限    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.1-2021 In vitro diagnostic test systems—Methods for evaluating performance—Part 1: Precision {译}
    体外诊断检验系统 性能评价方法 第1部分：精密度    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    WB/T 1116-2020 Specification for temperature control logistics service for In vitro diagnostic reagents {译}
    体外诊断试剂温控物流服务规范    		 China Material Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1728-2021 Clinical laboratory tests and In vitro diagnostic systems Reference methods for in vitro activity detection of yeast-like fungi antibacterial agents associated with infectious diseases {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菌剂的体外活性检测参考方法    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1789.2-2021 In-vitro diagnostic test systems - Performance evaluation methods - Part 2: Accuracy{译} {译}
    体外诊断检验系统 性能评价方法 第2部分：正确度    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1709-2020 Evaluation of Measurement Uncertainty of Calibrators for In vitro diagnostic Reagents {译}
    体外诊断试剂用校准物测量不确定度评定    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 0639—2019 In vitro diagnostic Medical Devices Manufacturer's Information for In Vitro Diagnostic Reagents for Biological Staining {译}
    体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1652—2019 General technical requirements for quality control substances for In vitro diagnostic reagents {译}
    体外诊断试剂用质控物通用技术要求    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1454-2016 (Self-vitro diagnostic medical devices for detecting the basic requirements)
    自我检测用体外诊断医疗器械基本要求    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1441-2016 (Performance evaluation of In vitro diagnostic medical devices General requirements)
    体外诊断医疗器械性能评估通用要求    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1244-2014 Purified water for In vitro diagnostic reagents
    体外诊断试剂用纯化水    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1227-2014 In vitro diagnostic reagent(kit)nomenclature for clinical chemistry
    临床化学体外诊断试剂(盒)命名    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1244-2014 Purified water for In vitro diagnostic reagents{译} {译}
    体外诊断试剂用纯化水    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 1227-2014 Clinical Chemistry In vitro diagnostic Reagents (Boxes) Nomenclature{译} {译}
    临床化学体外诊断试剂（盒）命名    		 China Pharmaceutics Industry Standards
    In vitro diagnostic
    English PDF
    YY/T 0688.2-2010 Clinical laboratory testing and In vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices. Part 2: Evaluation of performance of antimicrobial susceptibility test dev
    临床实验室检测和体外诊断系统-感染病原体敏感性试验与抗菌剂敏感性试验设备的性能评价 第2部分：抗菌剂敏感性试验设备的性能评价    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1153-2009 DNA microarray for In vitro diagnostics
    体外诊断用dna微阵列芯片    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 1151-2009 Protein microarray for In vitro diagnostics
    体外诊断用蛋白质微阵列芯片    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 0688.1-2008 Clinical laboratory testing and In vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices. Part 1: Reference method for testing the in vitro activity of antimicrobia
    临床实验室检测和体外诊断系统 感染病源体敏感性试验与抗菌剂敏感性试验设备的性能评价 第1部分：抗菌剂对感染性疾病相关的快速生长需氧菌的体外活性检测的参考方法    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY 0648-2008 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101:Particular requirements for In vitro diagnostic (IVD) medical equipment
    测量、控制和实验室用电气设备的安全要求 第2-101部分：体外诊断（ivd）医用设备的专用要求    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 0639-2008 In vitro diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
    体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF
    YY/T 0638-2008 In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
    体外诊断医疗器械 生物样品中量的测量 校准品和控制物质中酶催化浓度赋值的计量学溯源性    		 China Medicine & Medical Device Standards
    In vitro diagnostic
    English PDF

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