GB/T 25304-2010 Active
GB/T 25304-2010 Specific requirements for non-vascular self-expanding metallic stents
Abstract
This standard specifies the terms and definitions, expected performance, design attributes, materials, pre-clinical evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information for self-expanding metal stents used to dilate non-vascular luminal stenosis and their delivery systems.
This standard applies to non-vascular self-expanding metal stents for interventional therapy (which may be bare stents or coated stents, hereinafter referred to as stents), including esophageal stents, biliary stents, tracheal stents, and their corresponding delivery systems.
This standard does not apply to balloon-expandable stents. For balloon-expandable stents, it is recommended to refer to YY/T 0663.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 25304-2010 |
| CCS | Extracorporeal circulation, artificial organs, and prosthetic devices |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2011-05-01 |