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

Publish Date: 2010-11-10 Implement Date: 2011-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 15 Thousand words Pages: 10 pages

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

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