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
Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro
2016-01-26
YY/T 1465.6-2019
医疗器械免疫原性评价方法 第6部分：用流式细胞术测定动物脾脏淋巴细胞亚群
Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
2019-07-24
YY/T 1465.7-2021
医疗器械免疫原性评价方法 第7部分：流式液相多重蛋白定量技术
Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry
2021-03-09
YY/T 1465.3-2016
医疗器械免疫原性评价方法 第3部分：空斑形成细胞测定 琼脂固相法
Immunogenic evaluation method of medical devices—Part 3:Plaque forming cells assay—Agar gel solid-phase method
2016-07-29
YY/T 1465.4-2017
医疗器械免疫原性评价方法 第4部分：小鼠腹腔巨噬细胞吞噬鸡红细胞试验 半体内法
Immunogenic evaluation method of medical devices—Part 4:Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes—Ex-vivo method
2017-03-28
YY/T 1465.5-2016
医疗器械免疫原性评价方法 第5部分：用M86抗体测定动物源性医疗器械中α-Gal抗原清除率
Immunogenic evaluation method of medical devices—Part 5:Determination of α-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibody
2016-07-29
YY/T 0127.12-2008
牙科学 口腔医疗器械生物学评价 第2单元：试验方法 微核试验
Dentistry—Biological evaluation of medical devices used in dentistry Part 2:Test method—Micronucleus test
2008-04-25
YY/T 0127.14-2009
口腔医疗器械生物学评价 第2单元：试验方法 急性经口全身毒性试验
Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute oral toxicity test
2009-06-16
YY/T 0127.10-2009
口腔医疗器械生物学评价 第2单元：试验方法 鼠伤寒沙门氏杆菌回复突变试验(Ames试验)
Biological evaluation of medical devices used in dentistry—Part 2:Test method—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)