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
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 1465.5-2016
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 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 1465.2-2016
医疗器械免疫原性评价方法 第2部分：血清免疫球蛋白和补体成分测定(ELISA法)
Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay)
2016-01-26
YY/T 0681.6-2011
无菌医疗器械包装试验方法 第6部分:软包装材料上印墨和涂层抗化学性评价
Test methods for sterile medical device package-Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
2011-12-31
YY/T 0506.6-2009
病人、医护人员和器械用手术单、手术衣和洁净服 第6部分：阻湿态微生物穿透试验方法
Surgical drapes,gowns and clean air suits,used as medical devices,for patients,clinical staff and equipment—Part 6:Test method to determine the resistance to wet bacterial penetration