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Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
IDT ISO 10993-11:2006
全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
GB/T 16886的本部分规定了评价医疗器械材料导致潜在不良全身反应时的要求,并给出了试验步骤指南。
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