GB/T 25304-2025
UpcomingNon-vascular self-expanding metallic stent system
非血管自扩张金属支架系统
Application Summary AI generated
This standard specifies requirements, test methods, and labeling for non-vascular self-expanding metallic stent systems used in lumens such as the esophagus, biliary tract, colon, or trachea. It applies to implantable devices designed to maintain patency in non-cardiovascular anatomical pathways, ensuring safety and performance for palliative or therapeutic applications. The standard is used by manufacturers and regulatory bodies in China for product registration, quality control, and clinical evaluation of these stents.
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