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

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

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

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

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

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

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

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

2009-06-16