This part of GB/T 16886 describes the test methods for evaluating the in vitro cytotoxicity of medical devices. This standard specifies the methods of incubation for direct contact with devices and/or device extracts or contact with cultured cells by diffusion. This section applies to the appropriate biological parameters in vitro determination of biological responses of mammalian cells.
GB/T 16886.5-2017 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