Which Biological Tests Require The Use Of Two Extraction Media In Biological Evaluation Of Dental Materials? As The Subchronic Toxicity Test Requires A Large Sample Size, It Is Possible To Consider Using Only One Extraction Medium?

According to the provisions of GB/T 16886.12, when the device extract is used for test, polar and non-polar extraction media should be considered for all the biological tests. For the purpose of cytotoxicity test, the serum-containing culture medium is generally used for extraction, which contains both polar and non-polar medium, so one kind of extraction medium may be considered in this case. For the evaluation of subchronic systemic toxicity using the intravenous route, tests are recommended to be performed using polar extraction medium for intravenous administration and non-polar extraction medium for intraperitoneal administration at intervals. For the evaluation of subchronic systemic toxicity using the oral route, two kinds of media for polar and non-polar extracts should also be considered, but polar extracts are mostly adopted at present. The administrative counterpart can comprehensively evaluate and select the extraction medium according to the actual clinical use and application environment of the product.