GB/T 16886.11-2011
AbolishedBiological evaluation of medical devices - Part 11: Tests for systemic toxicity
医疗器械生物学评价 第11部分：全身毒性试验
Application Summary AI generated
This standard specifies test methods for evaluating the potential of medical devices to cause systemic toxicity, including acute, subacute, subchronic, and chronic effects. It is applied in the biological safety assessment of medical devices that have direct or indirect patient contact, such as implants, catheters, and drug delivery systems. Manufacturers and testing laboratories use it to ensure devices do not release harmful substances into the body during clinical use.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.