GB/T 16886.16-2021
ActiveBiological 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 principles and requirements for toxicokinetic studies of degradation products and leachables from medical devices. It is applied during the biological evaluation of medical devices that come into direct or indirect contact with the human body, particularly for assessing the absorption, distribution, metabolism, and excretion of chemical substances released from materials like implants, catheters, or drug delivery systems. The standard guides manufacturers and testing laboratories in generating data to support safety assessments and regulatory submissions.
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