GB/T 16886.18-2022
ActiveBiological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
医疗器械生物学评价 第18部分：风险管理过程中医疗器械材料的化学表征
Application Summary AI generated
This standard specifies the requirements for identifying and quantifying chemical constituents in medical device materials as part of a biological risk assessment. It is applied by manufacturers and testing laboratories during material selection, design verification, and regulatory submission to evaluate potential toxicological hazards. The standard supports compliance with ISO 10993-18 and is used for devices such as implants, surgical instruments, 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.