How To Select The Types Of Extraction Medium For Biological Tests?

The requirements of GB/T 16886 series standards should be referred to. When performing biological tests, the selected extraction medium should be appropriate to the properties and intended use of the final product and the purpose of the test, taking the chemical properties of the device materials, leachable substances or residual processing aids into account. For cytotoxicity test, since the serum­containing culture medium is the essential media to support cellular growth in the testing system and has the ability to extract both polar and non-polar substances, it should be considered the preferred extraction medium for cytotoxicity test, and under this condition, the serum-containing culture medium, can be the only extraction medium selected. For sensitization test, irritation test or intracutaneous reactivity test, acute systematic toxicity test and other biological tests, extraction using both polar and non-polar extraction medium should be considered. For genetic toxicity tests, as described in GB/T 16886.3, two appropriate extraction solvents should be used as appropriate, one of which should be polar extraction solvent, and The other could be non-polar solvent or liquid which is appropriate to the properties and use of the medical device. Both extraction solvents should be compatible with the testing system.