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YY/T 1897-2023 English PDF (YYT1897-2023)

YY/T 1897-2023 English PDF (YYT1897-2023)

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YY/T 1897-2023: Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
This document provides an in vitro mammalian cell micronucleus test method for the evaluation of nanomaterial medical devices or nanomaterials used in medical devices. By determining the number of micronucleus-containing cells after the cells are exposed to nanomaterial medical devices or nanomaterial test solutions used in medical devices, it is evaluated whether there are potential genotoxic risks. This document is applicable to the micronucleus test using immortalized cell cytokinesis blocking method to evaluate the genotoxicity of nanomaterial medical devices or nanomaterials used in medical devices. NOTE: others, for example, human peripheral blood primary cell culture method, may take this method as a reference, but methodological verification should be carried out.

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