GB/T 16886.5-2017
ActiveBiological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity
医疗器械生物学评价 第5部分：体外细胞毒性试验
Application Summary AI generated
This standard specifies test methods to evaluate the in vitro cytotoxic potential of medical devices, materials, and their extracts using cell culture techniques. It is applied during the biological safety assessment of medical devices, such as implants, surgical instruments, and drug delivery systems, to determine if leachable substances cause cell death or growth inhibition. Manufacturers and testing laboratories use this standard to comply with regulatory requirements for preclinical biocompatibility evaluation.
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