Stent Uniformity of Expansion: Measured parameters
- Stent expansion uniformity: Difference between the largest and smallest diameter measurement on a single stent deployed to its labelled diameter
Stent Uniformity of Expansion: Scope
- Balloon Expandable Stent
- Self-expending stent
- SS, CrCo, NiTi, any other metal alloys
Stent Uniformity of Expansion: ASTM F2081
- ISO 25539-2 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
- FDA GUIDELINES - GUIDANCE FOR INDUSTRY AND FDA STAFF NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS
- GLP STUDIES - CODE OF FEDERAL REGULATIONS CFR21, PART 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES (APRIL 2010)
- ASTM F2081-06 - STANDARD GUIDE FOR CHARACTERIZATION AND PRESENTATION OF THE DIMENSIONAL ATTRIBUTES OF VASCULAR STENTS
Stent Uniformity of Expansion: Associated stent expansion uniformity tests
- Stent Recoil and foreshortening
- Dimensional Attributes of Vascular Stents
- Stent radial force measurement
Stent Uniformity of Expansion: Test method description
A contactless optical gauging machine (Smartscope, OGP) is used (highest magnification: x145) to assess stent expansion uniformity. Diameter is measured at 3 axial locations of the stent and 2 perpendicular circumferential orientations when the stent is deployed at his labeled diameter.