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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 Evaluation 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 Evaluation 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 Evaluation method 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 Evaluation 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 Evaluation 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 Evaluation method 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 Evaluation method 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 Evaluation 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 Evaluation 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 Evaluation 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 Evaluation 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 Evaluation method vitro |
English PDF |
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