This part of GB/T 16886 describes the test methods for evaluating the in vitro cytotoxicity of medical devices. These methods specify that the following test articles be contacted and incubated with the cultured cells, either directly or by diffusion: a) with the leach solution of the device, and/or b) in contact with the device. These methods measure the in vitro biological response of mammalian cells with corresponding biological parameters.
GB/T 16886.5-2003 history
2018GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
2003GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity