Medical Device Standards – The Top 10 Standards on Vascular Stents

Vascular stents are the tubes that are placed in blood vessels to improve the flow of blood, either by preventing or counteracting a localized flow constriction.  Standards for those stents have been in force since the beginning of the 21st century.  Here are our top ten standards on the subject:

ASTM-F2079, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM-F2081, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM-F2394, Standard Guide for Measuring  Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM-F2477, Standard Test Method for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM-F2514, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM-F2606, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

ANSI/AAMI/ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

BS-EN-ISO-25539-2, Cardiovascular Implants – Endovascular Devices –  Vascular Stents

All of the above standards can be purchased from Document Center Inc.  Buy them at www.document-center.com, or phone 650-591-7600, fax 650-591-7617, or email info@document-center.com.