GB/T 16886.13-2017
ActiveBiological 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：聚合物医疗器械降解产物的定性与定量
Application Summary AI generated
This standard specifies methods for identifying and quantifying degradation products from polymeric medical devices under simulated clinical conditions. It is applied in the biological safety evaluation of devices such as implants, catheters, and drug delivery systems to assess potential risks from material breakdown. Manufacturers and testing laboratories use it to ensure compliance with regulatory requirements for biocompatibility.
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