EUROLAB provides mechanical and metallurgical tests for porous coating and porous medical devices; these include absorbable blasting medium (RBM), titanium plasma spray (TPA), hydroxyapatite (HA), electron beam melting (EBM) and direct metal laser sintering (DMLS).
To increase the fixation of an implant, a porous coating is usually applied to medical devices. Newer technologies also enable the direct integration of porous structures into the main materials of the devices. To market an implant with a porous structure, there are some tests that need to be done to verify the mechanical and metallurgical properties of the coating.
These tests are useful for meeting the FDA or legal requirements, helping to research and develop new coating processes and technologies, and providing insight to compare or verify coating suppliers.
Mechanical tests include static and dynamic stress, cutting and bending, and wear. These tests are carried out on specially made porous structure test samples that vary depending on the test method.
For the shear test, the sample consists of a metallic cylinder with an outer diameter of 0.75 ”and a length of 1 to 1.25 inches, the porous coating is glued to one flat side of the metal. The coated sample is attached to an uncoated sample and then dynamically cut to a fault or to a predetermined number of cycles.
The tensile test of a porous structure uses a test apparatus consisting of a disc-shaped sample, one side coated and one uncoated and connected between two test armatures. The test specimen with 1 "outer diameter is subjected to tensile load until it fails, that is, the components are separated.
Abrasion testing is critical for porous structures because poor integrity can have adverse effects in vivo. The most common test is Taber abrasion, which consists of a circular porous coating sample that is repeatedly contacted by an abrasive impeller. The results can be used for comparative purposes when evaluating the coating types of supplier types or can be compared with the general acceptance criteria set by a regulatory agency.
The rotary beam test consists of an hourglass-shaped coated rod whose long axis is loaded as a beam. During the test, the surface material of the sample is most exposed to stress, making it an ideal test for determining the properties of a porous structure.
The friction coefficient test consists of measuring the static and dynamic friction forces between a porous structure and a polyurethane bone analogue, animal tissue, or human donor tissue. Static resistance is the force required to start motion, dynamic resistance is the friction force required to maintain motion. We perform friction test coefficient on internal procedures or client protocols.
EUROLAB's metallurgical laboratories make various evaluations on porous coating samples such as coating thickness, coating surface roughness, volume percentage cavity and morphology of pores.
These test methods examine various porous coatings that adhere to non-porous medical implants. Substrates are evaluated using a digital image analysis system and proprietary software programming to determine coating thickness, volume, and percentage of void (between the tissue interface and the substrate interface).
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
