China vitro Industry Standards English PDF List

China "vitro" Industry Standards English PDF List:

Standard Code	Standard Title	Standard Class	Order
YY/T 0127.16-2009	Biological Evaluation of Dental Medical Devices Unit 2: Test Methods Chromosomal Aberration Test of Mammalian Cells in vitro {译} 口腔医疗器械生物学评价第2单元：试验方法哺乳动物细胞体外染色体畸变试验	China Pharmaceutics Industry Standards vitro	English PDF
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 vitro	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 vitro	English PDF
YY/T 1897-2023	Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test {译} 纳米医疗器械生物学评价遗传毒性试验体外哺乳动物细胞微核试验	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 0993—2015	Biological Evaluation of Medical Devices Nanomaterials: In vitro Cytotoxicity Tests (MTT Test and LDH Test) {译} 医疗器械生物学评价纳米材料：体外细胞毒性试验（MTT试验和LDH试验）	China Pharmaceutics Industry Standards vitro	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 vitro	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 vitro	English PDF
YY/T 1829-2022	Dentistry - In vitro evaluation method of dentinal tubule occlusion effect {译} 牙科学牙本质小管封堵效果体外评价方法	China Pharmaceutics Industry Standards vitro	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 vitro	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 vitro	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 vitro	English PDF
YY/T 1808-2021	In vitro skin irritation test for medical devices {译} 医疗器械体外皮肤刺激试验	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1806.2-2021	Evaluation method for in vitro degradation performance of biomedical materials-Part 2: Mussel mucin {译} 生物医用材料体外降解性能评价方法第2部分：贻贝黏蛋白	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1806.1-2021	Evaluation method for in vitro degradation performance of biomedical materials-Part 1: Degradable polyesters {译} 生物医用材料体外降解性能评价方法第1部分:可降解聚酯类	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1764-2021	Test method for in vitro axial, bending and torsional durability of vascular stents {译} 血管支架体外轴向、弯曲、扭转耐久性测试方法	China Pharmaceutics Industry Standards vitro	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 vitro	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 vitro	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 vitro	English PDF
YY/T 1746-2020	Absorbable surgical sutures - Test method for breaking strength after in vitro hydrolysis {译} 可吸收性外科缝线体外水解后断裂强力试验方法	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1698-2020	Medical devices for human in vitro assisted reproductive technology {译} 人类体外辅助生殖技术用医疗器械辅助生殖穿刺取卵针	China Pharmaceutics Industry Standards vitro	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 vitro	English PDF
YY/T 1718-2020	Medical devices for human in vitro assisted reproductive technology Embryo transfer catheter {译} 人类体外辅助生殖技术用医疗器械胚胎移植导管	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1477.5—2020	Standard test models for evaluating the performance of contact wound dressings - Part 5: In vitro models for evaluating hemostatic performance {译} 接触性创面敷料性能评价用标准试验模型第5部分：评价止血性能的体外模型	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 0870.6—2019	Genotoxicity testing of medical devices - Part 6: In vitro mammalian cell micronucleus test {译} 医疗器械遗传毒性试验第6部分：体外哺乳动物细胞微核试验	China Pharmaceutics Industry Standards vitro	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 vitro	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 vitro	English PDF
YY/T 1649.1—2019	Interaction test between medical device and platelets - Part 1: In vitro platelet count method {译} 医疗器械与血小板相互作用试验第1部分：体外血小板计数法	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 0870.2—2019	Medical device genotoxicity test - Part 2: In vitro mammalian cell chromosomal aberration test {译} 医疗器械遗传毒性试验第2部分：体外哺乳动物细胞染色体畸变试验	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1649.2-2019	Medical device and platelet interaction test Part 2: Determination of platelet activation products (β-TG, PF4 and TxB2) in vitro {译} 医疗器械与血小板相互作用试验第2部分：体外血小板激活产物（β-TG、PF4和TxB2）的测定	China Pharmaceutics Industry Standards vitro	English PDF
YY/T 1477.1-2016	(Wound dressing performance evaluation standard test model - Part 1: Evaluation of the antibacterial activity in vitro wound model) 接触性创面敷料性能评价用标准试验模型第1部分：评价抗菌活性的体外创面模型	China Medicine & Medical Device Standards vitro	English PDF
YY/T 1465.1-2016	(Evaluation of immunological methods of medical devices - Part 1 in vitro T lymphocyte transformation test) 医疗器械免疫原性评价方法第1部分:体外t淋巴细胞转化试验	China Medicine & Medical Device Standards vitro	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 vitro	English PDF
YY/T 1447-2016	(Surgical implants implants apatite-forming ability in vitro assessment) 外科植入物植入材料磷灰石形成能力的体外评估	China Medicine & Medical Device Standards vitro	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 vitro	English PDF
YY/T 1434-2016	(Human Assisted Reproductive Technology in vitro mouse embryo in vitro testing of medical devices) 人类体外辅助生殖技术用医疗器械体外鼠胚试验	China Medicine & Medical Device Standards vitro	English PDF
YY/T 0993-2015	Biological evaluation of medical devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay) 医疗器械生物学评价纳米材料：体外细胞毒性试验（mtt试验和ldh试验	China Medicine & Medical Device Standards vitro	English PDF
SN/T 4150-2015	(Corn vitro test chemicals) 化学品离体鸡眼试验	China Import Export Inspection Standards vitro	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 vitro	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 vitro	English PDF
SN/T 3948-2014	(Chemicals in vitro skin irritation: Recombinant Human Epidermal test) 化学品体外皮肤刺激：重组人表皮试验	China Import Export Inspection Standards vitro	English PDF
SN/T 3899-2014	(Cosmetics alternative culture in vitro cell preparation and sample test norms of good) 化妆品体外替代试验良好细胞培养和样品制备规范	China Import Export Inspection Standards vitro	English PDF
SN/T 3898-2014	(Cosmetics vitro alternative test method validation procedures) 化妆品体外替代试验方法验证规程	China Import Export Inspection Standards vitro	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 vitro	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 vitro	English PDF
SN/T 3715-2013	Cosmetics-In vitro test method for embryotoxicity-Rat whole embryo culture test 化妆品体外发育毒性试验大鼠全胚胎实验法	China Import Export Inspection Standards vitro	English PDF
YY/T 0870.3-2013	Test for genotoxicity of medical devices. Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells 医疗器械遗传毒性试验第3部分：用小鼠淋巴瘤细胞进行的体外哺乳动物细胞基因突变试验	China Medicine & Medical Device Standards vitro	English PDF
YY/T 0870.2-2013	Test for genotoxicity of medical devices. Part 2: In vitro mammalian chromosome aberration test 医疗器械遗传毒性试验第2部分：体外哺乳动物染色体畸变试验	China Medicine & Medical Device Standards vitro	English PDF
SN/T 3526-2013	Chemicals. Validation basic requirements of alternative methods for in vitro toxicological testing 化学品体外毒性试验替代方法验证的基本要求	China Import Export Inspection Standards vitro	English PDF
SN/T 3312-2012	Interferon-γ release assay for the diagnosis of Mycobacterium tuberculosis in vitro 结核分枝杆菌γ-干扰素体外检测方法	China Import Export Inspection Standards vitro	English PDF
SN/T 3084.1-2012	Occular irritation test of cosmetics for import and export. Neutral red uptake assays in vitro 进出口化妆品眼刺激性试验体外中性红吸收法	China Import Export Inspection Standards vitro	English PDF
YY/T 0808-2010	Standard test methods for in vitro pulsatile durability testing of vascular stents 血管支架体外脉动耐久性标准测试方法	China Medicine & Medical Device Standards vitro	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 vitro	English PDF
SN/T 2497.6-2010	Test method of import and export dangerous chemicals. Part 6: In vitro sister chromatid exchange assay in mammalian cells 进出口危险化学品安全试验方法第6部分：哺乳类动物细胞姐妹染色单体互换体外试验	China Import Export Inspection Standards vitro	English PDF
SN/T 2497.24-2010	Test method of import and export dangerous chemicals. Part 24:vitro test of cell immunologic function 进出口危险化学品安全试验方法第24部分：细胞免疫功能体外检测方法	China Import Export Inspection Standards vitro	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 vitro	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 vitro	English PDF
YY/T 0127.16-2009	Biological evaluation of medical devices used in dentistry. Part 2: Test method. In vitro mammalian chromosome aberration test 口腔医疗器械生物学评价第2单元：试验方法哺乳动物细胞体外染色体畸变试验	China Medicine & Medical Device Standards vitro	English PDF
SN/T 2246-2009	Chemicals. In vitro skin corrosion. Transcutaneous electrical resistance test(TER) 化学品体外皮肤腐蚀经皮电阻试验	China Import Export Inspection Standards vitro	English PDF
YY/T 0690-2008	Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy 临床实验室测试和体外医疗器械口服抗凝药治疗自测体外监测系统的要求	China Medicine & Medical Device Standards vitro	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 vitro	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 vitro	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 vitro	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 vitro	English PDF
YY/T 0474-2004	Poly (L-lactide) resins and fabricated forms for surgical implants. In vitro degradation testing 外科植人物用聚 l-丙交酯树脂及制品体外降解试验	China Medicine & Medical Device Standards vitro	English PDF
YY/T 0473-2004	Implants for surgery. Copolymers and blends based on polylactide. In vitro degradation testing 外科植入物聚交酯共聚物和共混物体外降解试验	China Medicine & Medical Device Standards vitro	English PDF

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