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 methods 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 methods 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 methods 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 methods 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 methods 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 methods 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 methods 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 methods 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 methods 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 methods 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 methods vitro |
English PDF |
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