GB/T 25304-2010
Active
National standards
GB/T 25304-2010 Specific requirements for non-vascular self-expanding metallic stents
GB/T 25304-2010 Specific requirements for non-vascular self-expanding metallic stents
Basic Information
Standard Code:
GB/T 25304-2010
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2010-11-10
Implement Date:
2011-05-01
Pages:
10 pages
Scope
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.
Development Information
Referenced Standards
GB/T 15812.1-2005 Catheters other than intravascular catheters—Part 1:Test methods for common properties
YY 0500-2004 Cardiovasular implants—Tubular vascular prostheses
YY/T 0640-2008 Non-active surgical implants—General requirements
GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
YY/T 0695-2008 Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small lmplant devices
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Related Standards
GB 12264-1990
Replaced
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced