GB/T 16886.18-2011
AbolishedBiological evaluation of medical devices - Part 18: Chemical characterization of materials
医疗器械生物学评价 第18部分：材料化学表征
Application Summary AI generated
This standard specifies the framework for identifying and quantifying the chemical constituents of medical device materials. It is applied during the biological evaluation process to assess potential toxicological risks from leachable substances, ensuring material safety for clinical use. The standard is used by manufacturers and testing laboratories for material qualification, quality control, and regulatory submissions.
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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.