This standard includes technical requirements, test principles, test methods, inspection rules, labeling, packaging, transportation and storage, etc., to make a more comprehensive and systematic evaluation of product safety and effectiveness, and to unify technical parameters. The standard uses simulated blood samples for testing as quality controls to measure the reaction time (R) required from the blood sample to the formation of the first detectable blood clot, the blood clot formation time (K), and the blood clot formation time (K). The gradually formed dynamic characteristic value (ANG) and maximum amplitude (MA) have an accuracy range that is better than or equal to similar foreign products.