Standard No.:	GB/T 25304-2025
English Name:	Non-vascular self-expanding metallic stent system
Chinese Name:	非血管自扩张金属支架系统
Chinese Classification:	C45    Extracorporeal circulation, artificial organ and prosthesis device
Professional Classification:	GB    National Standard
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Source Content Issued by:	SAMR, SAC
Issued on:	2025-10-05
Implemented on:	2026-11-1
Status:	to be valid
Superseding:	GB/T 25304-2010 Specific requirements for non-vascular self-expanding metallic stents
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了用于非血管腔体的自扩张金属支架（以下简称支架)及其输送系统的预期性能、设计属性、材料、设计评价、制造、灭菌、包装和制造商提供信息的要求。
本文件适用于介入治疗用非血管自扩张金属支架（裸支架或覆膜支架)，包括食道支架、胆道支架、气管支架、肠道支架、尿道支架等及其相应的输送系统。