A crucial component of safety assurance in the assessment of medical devices is the genetic toxicity test.More detailed guidelines for the identification of genetic toxicity in medical devices have been released with the introduction of GB/T 16883.3-2019.Additionally,the substance of the experiment has various requirements,as does YY/T 0870,a sequence of line mark updates.In order to provide guidance for particular genetic toxicity testing of medical devices,this study will concentrate on the effects of new standards on genetic toxicity testing of medical devices.