The standard “ASTM F2081-01 Standard guide for characterization and presentation of dimensional properties of vascular stents” developed by the American Society for Testing and Materials (ASTM) describes the requirements and recommended measurement methods for describing the dimensional attributes of vascular stents that are considered important for successful clinical performance. The delivery system, packaged and labeled for specific use during stent deployment, is also within the scope of this standard.
This standard only addresses the dimensional properties of stents. Material properties and stent functional properties are not covered here. All dimensional properties described in this standard refer to in vitro (bench-top) characterization. Actual in vivo properties may differ slightly due to variable patient factors, e.g. vessel compliance.
This standard contains recommendations that are generally applicable to balloon-expandable and self-expanding stents manufactured from metals and metal alloys. Any features specific to covered stents or polymeric or biodegradable stents are not specifically addressed, but do not preclude the application of this guideline to these products.
Although not specifically included in this standard, stents indicated for placement in nonvascular sites such as the esophagus or bile duct may also be characterized by the methods included herein. Similarly, this guideline does not contain recommendations for endovascular grafts (stent-grafts) or other conduit devices commonly used to treat aneurysmal disease or peripheral vascular trauma or to provide vascular access, although some of the information contained herein may apply to these devices.
This standard does not include recommendations for balloon catheters sold as stand-alone angioplasty catheters, although some catheters may be used for the delivery of unassembled stents provided without a delivery system. Requirements for angioplasty catheters are contained in “ISO 10555-1 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements” and “ISO 10555-4 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters”.
Blood is carried throughout the body by blood vessels called veins and arteries. If a blood vessel becomes blocked by a buildup of fat, cholesterol, and other substances, the blockage can restrict blood flow and lead to a variety of health problems. In these cases, a vascular stent procedure is performed to treat the condition.
A vascular stent is a small tube that is placed inside a blocked blood vessel to keep it open. A stent restores blood flow in the vessel. These stents are usually made of metal or plastic. Stent grafts are larger stents used for larger arteries and are made of a special material. Stents may also be coated with medication to help prevent a blocked artery from closing. Stents can be placed in many areas of the body. Vascular stents are often placed as part of a peripheral artery angioplasty.
Common areas treated with stents include:
For the purposes of ASTM F2081-01, a vascular stent refers to a synthetic tubular structure that is permanently implanted in the native or grafted vasculature and is intended to provide mechanical radial support to increase vascular patency. For the purposes of this guideline, a stent is metallic and is not covered with synthetic textile or tissue graft material.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, it also provides testing services defined in the “ASTM F2081-01 Standard Guide for the Characterization and Presentation of Dimensional Properties of Vascular Stents” standard with its trained and expert staff and advanced technological equipment.
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