GB/T 16886.6-2022
ActiveBiological evaluation of medical devices—Part 6:Tests for local effects after implantation
医疗器械生物学评价 第6部分：植入后局部反应试验
Application Summary AI generated
This standard specifies test methods for evaluating the local biological response of living tissue to implanted medical devices. It is applied during preclinical safety assessments of materials intended for long-term or permanent implantation in the human body, such as orthopedic implants, cardiovascular stents, or dental implants. The testing context involves surgically placing the device material into animal tissue (e.g., subcutaneous, intramuscular, or bone sites) to observe histopathological reactions over specified time periods.
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