GB/T 16886.13-2001
AbolishedBiological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices
医疗器械生物学评价 第13部分:聚合物医疗器械的降解产物的定性与定量
Application Summary AI generated
This standard specifies methods for identifying and quantifying degradation products released from polymeric medical devices under simulated clinical conditions. It is applied during the biological safety evaluation of devices such as implants, catheters, and drug delivery systems to assess potential risks from material breakdown. The testing context includes in vitro degradation studies to ensure compliance with biocompatibility requirements for regulatory approval.
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