GB/T 25304-2010

Active

Specific requirements for non-vascular self-expanding metallic stents

非血管自扩张金属支架专用要求

Standard Type
GBT
ICS
11.040.40
CCS
C45
Status
Active
Issue Date
2010-11-10
Implementation
2011-05-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the technical requirements, test methods, and labeling for non-vascular self-expanding metallic stents used in medical procedures. It applies to stents intended for placement in non-vascular lumens such as the esophagus, biliary tract, or trachea to maintain patency. The standard ensures safety and performance in clinical settings, guiding manufacturers and regulatory bodies in product evaluation and quality control.

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.