GB/T 16886.3-2008
AbolishedBiological evaluation of medical devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity
医疗器械生物学评价 第3部分：遗传毒性、致癌性和生殖毒性试验
Application Summary AI generated
This standard specifies test methods for evaluating the genotoxicity, carcinogenicity, and reproductive toxicity of medical devices and their constituent materials. It is applied during the biological safety assessment of devices that contact the human body, such as implants, surgical instruments, and drug delivery systems, to ensure they do not cause genetic damage, cancer, or reproductive harm. The standard is used by manufacturers, testing laboratories, and regulatory bodies in China to meet mandatory safety requirements for medical device approval and market access.
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