YY/T 1465.1-2016 Translated English of Chinese Standard. (YYT 1465.1-2016, YY/T1465.1-2016, YYT1465.1-2016): Immunogenic Evaluation Method of Medical Devices - Part 1: T Lymphocyte Transformation Test in VitroThis Part gives the MTT method and CFSE method for the T lymphocyte transformation test in vitro; it is applicable to evaluate the effect of medical devices/materials on the T lymphocyte immune function. |
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37°C incubator containing 400g to centrifuge absorbance value Add ConA add RPMI1640 nutrient Add the cell Animal Welfare antigen applicable appropriate statistical method Biological Evaluation Biomaterials Carboxyfluorescein diacetate succinimidyl cell proliferation cell suspension centrifuge for 5min CFSE method CFSE-labeled China Food Collect the cells ConA to positive concentration is 5µg/mL control group cell control group till cultivation days detect the proliferation detecting the cell diacetate succinimidyl ester discharge the supernatant DMSO document Evaluation of Medical FCS to stop final concentration flow cytometry fluorescence intensity formazan particles GB/T immune response Immunogenic Evaluation Method Immunotoxicology Testing living cells lymphocyte immune function Lymphocyte Transformation Test marker for detecting Medical Devices medical devices/materials method and CFSE mitogen MTT method number of cultivation nutrient solution containing positive control group RPMI1640 nutrient solution Sample Preparation Serum specific test methods staining marker strain test animals Test group test in vitro test results test sample testing staff YY/T