Outlined below is a list of the tests Anecto provides to ensure the mechanical integrity of an implantable device. Anecto has the capacity to perform these tests on a wide range of implant devices.
- This test allows us to assess the maximum stress a product can withstand before the products cross-section begins to fail.
- This test is performed using a JEOL Scanning Electron Microscope, with GATAN micro tensile tester in the SEM chamber. Has typically been used for testing stent strut deflection.
- Tests performed to ISO standards or customer defined requirements.
Catheter Bend Test
- This test is designed to measure the bending stiffness of the product in both its crimped state (in the delivery device) and its delivered state.
- Utilises Zwick tensile tester equipped with variable span 3- point tester.
- ASTM F2606 “Standard Guide for Three-Point Bending of Balloon Vascular Stents and Stent Systems”
- This test is an aggressive accelerated cycling of the device designed to mimic 10 years of the implant being in an actual vessel. This rapid acceleration allows us to accurately gauge if a product is likely to fail during its life cycle. This test is carried out using a BOSE SGT 9110 Tester, which can test devices with diameters up to 14mm.
- Fatigue of non-standard implant devices using custom developed systems.
- ASTM f2477 – 07 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
- This test allows us to monitor how resistive a device is to compressive forces (generally from the implant vessel). This test is performed using an in-house developed test system.
- ASTM F2079 – 09 Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents.
Stent Detachment Test
- This test is used to identify the force required to remove the crimped stent from a delivery catheter.
- Our test set-up is designed to match ASTM F2394 – 07.
- ASTM F2394 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
For more information on Anecto’s Mechanical Performance services please…
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