The ASTM F2129-19a standard, published by the American Society for Testing and Materials (ASTM), describes a test method for evaluating the corrosion susceptibility of small, metallic, implantable medical devices or their components using cyclic potentiodynamic polarization. The primary types of devices evaluated using this test method include, but are not limited to: vascular stents, ureteral stents , filters, support segments for endovascular grafts, cardiac occluders, aneurysm or ligation clips, staples, and similar devices.
The test method described is used to evaluate a device in its final state and finish as it will be implanted. These small devices should be thoroughly tested. The upper limit on device size is determined by the test device's capacity to deliver electrical current. The following test methods are assumed to be used for material screening:
Due to the variety of configurations and sizes of implants, this test method provides a variety of specimen holder configurations. This test method is designed for use in implantable devices made of metals with relatively high corrosion resistance.
Corrosion testing provides critical information throughout a product lifecycle, from material selection early in the design process to quality control and failure analysis. Advanced laboratories are equipped to evaluate composition, microstructure, surface properties and corrosion performance. Specific sample preparation and advanced microscopy techniques allow for detailed observation of microstructural components.
Corrosion testing is particularly important in medical device systems, as uncontrolled release of metal ions can have harmful biological effects. The approach of the ASTM F2129 standard applies cyclic potentiodynamic polarization to small medical implant devices in final form and finish.
Among the numerous test, measurement, analysis and evaluation studies it has given for businesses in various sectors, our organization, with its trained and expert staff and advanced technological equipment, is responsible for carrying out cyclic potentiodynamic polarization measurements in order to determine the corrosion sensitivity of small implant devices within the scope of ASTM F2129-19a standard. It also provides standard testing services.
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