GB/T 16886.17-2025
UpcomingBiological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
医疗器械生物学评价 第17部分：医疗器械成分的毒理学风险评估
Application Summary AI generated
This standard specifies the methodology for conducting toxicological risk assessments of chemical constituents released from medical devices. It is applied by manufacturers and regulatory bodies during the design, material selection, and biocompatibility evaluation phases to ensure patient safety. The standard is particularly relevant for assessing leachables and degradation products from devices such as implants, catheters, and drug-delivery systems.
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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.