YY/T 1465.4-2017 Translated English of Chinese Standard. (YYT 1465.4-2017, YY/T1465.4-2017, YYT1465.4-2017): Immunogenic evaluation method of medical devices - Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes - Ex-vivo method
https://www.chinesestandard.net, 2018/09/01 - 11 ページ
This Part of YY/T 1465 gives the ex-vivo method for the determination of phagocytosis of mouse peritoneal macrophages on chicken erythrocytes. This Part applies to the evaluation of the influence of medical devices/materials on phagocytic ability of macrophages.
ability of macrophages animal contact mode Animal welfare antigen Biological evaluation caused by medical chicken erythrocyte suspension clinical application mode contact/immune mode document dose set dose-effect relationship evaluation of medical Ex-vivo method extraction medium function of macrophages immune cells immune response Immunogenic evaluation method immunotoxicity immunotoxicology test incubate influence of medical injected with 0.5 injected with positive intended clinical application intraperitoneally injected laboratory Lymphocyte macrophages counted macrophages include macrophages on chicken medical devices medical devices/materials method of medical mg/kg mouse macrophages mouse peritoneal macrophages negative control group normal saline number of macrophages perform this test peritoneal cavity phagocytic ability phagocytic function phagocytic index phagocytic percentage phagocytose chicken erythrocytes Phagocytosis of mouse positive control group positive control substance positive control test requirements of GB/T Sample contact sample extracts selected specific test methods supernatant test animals test group test in GB/T test report test sample test substance Total number YY/T