GB/T 16886.17-2005
ActiveBiological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
医疗器械生物学评价 第17部分：可沥滤物允许限量的建立
Application Summary AI generated
This standard provides a framework for determining the maximum acceptable levels of chemical substances that can leach from medical devices into the body. It is applied during the biological safety evaluation of medical devices, specifically for manufacturers and testing laboratories to establish safe exposure limits for leachable compounds based on toxicological risk assessment. The standard is critical for ensuring patient safety in devices that have prolonged or permanent contact with tissues or bodily fluids.
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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.