ISO 10993-16:2017

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ISO 10993-16:2017 is a part of the ISO 10993 series, which is a set of international standards for the biological evaluation of medical devices. Specifically, this standard focuses on the design and performance of toxicokinetic studies for medical devices, particularly regarding degradation products and leachables. It provides principles for understanding how these substances are absorbed, distributed, metabolized, and excreted (ADME) in the body, helping to assess their potential toxicity.