YY/T 1465.2-2016 Translated English of Chinese Standard. (YYT 1465.2-2016, YY/T1465.2-2016, YYT1465.2-2016): Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)https://www.chinesestandard.net, 02.02.2019 - 10 Seiten This Part gives the method using the enzyme-linked immunosorbent assay to determine the levels of serum immunoglobulin and complement component; it is suitable for the evaluation of immune response products induced by medical devices/materials. |
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advisable to determine Animal Welfare animals/group antibody antigen-antibody complex applicable appropriate statistical method assay to determine Biological Evaluation biological significance blood body’s immune response China Food clinically combining the biological Complement Component Detection Data analysis Record data distribution Detection of serum detection values determine the test document dose ELISA Enzyme-Linked Immunosorbent Assay Evaluation of Medical Food and Drug GB/T group of mice horseradish peroxidase human body humoral immune response IgG and IgM immune system Immunogenic Evaluation Method Immunoglobulin and Complement Immunotoxicology Testing levels of serum Medical Devices medical devices/materials Method of Medical mouse Negative control group Positive control group preliminary test recommended to detect Record the detection results by combining sample according Sample Preparation Select the appropriate serum complement component serum immunoglobulin specific test methods statistical method according Take the test Terms and Definitions test animals Test grouping Test Report test results test sample test substance values of serum YY/T