YY/T 1897-2023: Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test

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Scope

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.

Basic Data

Standard ID	YY/T 1897-2023 (YY/T1897-2023)
Description (Translated English)	Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.30
Word Count Estimation	12,181
Date of Issue	2023-06-20
Date of Implementation	2024-07-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the in vitro mammalian cell micronucleus test method for evaluating nanomedical devices or nanomaterials used in medical devices. number of cells to evaluate whether it has a potential risk of genotoxicity. This standard applies to the evaluation of the genotoxicity of nanomedical devices or nanomaterials used in medical devices using the micronucleus test of immortalized cell cytokinesis blocking method.