Standard No.:	GB/T 25304-2010
English Name:	Specific requirements for non-vascular self-expanding metallic stents
Chinese Name:	非血管自扩张金属支架专用要求
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
Issued by:	AQSIQ
Issued on:	2010-11-10
Implemented on:	2011-5-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	6000 words
Price(USD):	180.00
Delivery:	via email in 1~3 business day

本标准规定了用于扩张非血管腔体狭窄的自扩张金属支架及其输送系统的术语和定义、预期性能、设计属性、材料、临床前评估、制造、灭菌、包装和制造商提供的信息。
本标准适用于介入治疗用非血管自扩张金属支架(可以是裸支架或覆膜支架,以下简称支架),包括食道支架、胆道支架、气管支架及其相应的输送系统。
本标准不适用于球囊扩张支架,球囊扩张支架建议参照YY/T0663。