GB/T 25304-2025

Upcoming

Non-vascular self-expanding metallic stent system

非血管自扩张金属支架系统

Standard Type
GBT
ICS
11.040.40
CCS
C45
Status
Upcoming
Issue Date
2025-10-05
Implementation
2026-11-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

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.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.