1 Scope
This part of GB/T 16886 describes test methods to assess the in vitro cytotoxicity of medical devices.
These methods specify the incubation of cultured cells either directly or through diffusion:
a) with extracts of a device, and/or
b) in contact with a device.
These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of GB/T 16886. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 16886.1 Biological evaluation of medical devices — Part 1: Evaluation and testing (GB/T 16886-2001, idt ISO 10993-1:1997)
GB/T 16886.12-2000 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (idt ISO 10993-12:1996)
