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| 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method 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 Test method vitro |
English PDF |
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