YY/T 1897-2023 Translated English of Chinese Standard (YY/T 1897-2023, YYT1897-2023): Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]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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1640 culture fluid ability to uptake Activation system S9 albumin Biological Evaluation Carcinogenicity cell culture fluid cell doubling Cell Micronucleus Test cells to uptake CHL and TK6 chromosome damage concentration range control means reproducible culture medium CytoB cytokinesis blocking method cytotoxicity devices or nanomaterials document evaluate the genotoxicity evaluation of nanomaterial GB/T GB/Z genotoxic risks genotoxicity evaluation method Genotoxicity of Nanomaterial genotoxicity test group without metabolic highest concentration Main Equipment Mammalian Cell Micronucleus medical device products medium negative control metabolic activation Micronucleus-containing cell counting nanomaterial medical devices Nanomaterial Products nanomaterials by cells nanoparticles Nanotechnologies negative control materials OECD osmotic pressure p53 gene preparation concentration preparation method reagents Result Determination risk of nanomaterials S9 mixture Sichuan specified date system when materials test conditions Test for Genotoxicity test results test sample test solution test system test using cytokinesis TK6 cells treatment group uptake nanomaterials uptake of nanomaterials Vitro Mammalian Cell vitro micronucleus test