GB/T 16886.16-2013
AbolishedBiological evaluation of medical devices―Part 16: Toxicokinetic study design for degradation products and leachables
医疗器械生物学评价 第16部分：降解产物与可沥滤物毒代动力学研究设计
Application Summary AI generated
This standard specifies the design and conduct of toxicokinetic studies to assess the absorption, distribution, metabolism, and excretion of degradation products and leachables from medical devices. It is applied during the biological evaluation of implantable or long-term contact medical devices to determine the systemic exposure and potential toxicity of chemical substances released into the body. The standard is used by manufacturers and testing laboratories to ensure safety compliance with ISO 10993-16 requirements for regulatory submissions.
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