Standard Number: YY/T 1897-2023(YY/T1897-2023)
Chinese:纳米医疗器械生物学评价 遗传毒性试验 体外哺乳动物细胞微核试验
English:Biological evaluation of nanomaterial medical devices-Test for genotoxicity-In vitro mammalian cell micronucleus test
Effective Date:2024-07-01
ICS:11.040.30
Standard Applicability:This document gives an in vitro mammalian cell micronucleus test method for evaluating nanomedical devices or nanomaterials used in medical devices for potential genotoxicity risk by determining the number of micronucleus-containing cells after exposure of cells to nanomedical devices or nanomaterials used in medical devices in a test solution. This document applies to the evaluation of the genotoxicity of nanomedical devices or nanomaterials used in medical devices using the micronucleus test by the cytoplasmic division blocking method of immortalized cells.
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