This document provides an in vitro mammalian cell micronucleus test method for the evaluation of nanomedical devices or nanomaterials used in medical devices by determining the micronucleus content of cells after exposure to nanomedical devices or nanomaterials used in medical devices. Nuclear cell number to evaluate whether it has potential genotoxic risk. This document is applicable to the micronucleus test using immortalized cell cytokinesis blocking method to evaluate the genotoxicity of nanomedical devices or nanomaterials used in medical devices.
YY/T 1897-2023 history
2024YY/T 1897-2023 Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test