Mechanical tests include abrasion along with static and dynamic tension, shear, and bending. Metallurgical tests include thickness, surface roughness, and porosity levels. These tests are beneficial in satisfying FDA or regulatory requirements, helping with research and development of new coating processes and technologies, and providing insight to compare or validate coating suppliers.
In order to bring an implant with a porous coating to market, there are a number of tests that must be performed to verify the mechanical properties of the coating. These tests are performed on specially made porous coating test samples, which vary depending upon the test method.
Shear Testing (ASTM F1044 & ASTM F1160)
For shear testing, the coating sample consists of a metallic cylinder that is 1” or less in diameter with the porous coating adhered to one flat side of the metal. The coated specimen is then loaded in shear either statically until failure or dynamically to a pre-determined cycle count.
Tensile Testing (ASTM F1147)
This test is also performed using a coated, metallic sample which is loaded in tension until failure.
Abrasion Testing (ASTM F1978)
Abrasion testing is critical for porous coatings, as high wear rates can have adverse effects in-vivo. The most commonly performed test is Taber abrasion, which consists of a circular coating sample which is repeatedly contacted by an abrasive wheel. Results can be used for comparative purposes when evaluating coating types or suppliers.
Rotating Beam Fatigue (ASTM F1160)
Rotating beam testing consists of a hourglass-shaped, coated rod which is loaded about its long axis as a beam. During testing, the specimen’s surface material is subject to the greatest amount of stress, making this an ideal test for determining properties of porous coatings.
Element’s metallurgical laboratory performs a variety of evaluations on porous coating samples, including coating thickness, coating surface roughness, porosity level (volume percent void), and morphology of pores.
Our in-house evaluation tools include:
- Comprehensive stereological analysis in accordance with ASTM F1854. Read More
- Stereomicroscope capable of evaluating specimens from 5X - 50X
- Metallographic microscope capable of evaluating specimens from 50X - 1000X
- Digital microphotography
- Digital image analysis software for fast and efficient analysis
- Specimen mounting and polishing equipment
- Microetching capability with a variety of chemical etchants
- Low speed diamond saws for precise, low-stress, low-heat sectioning
- SEM services available for higher magnification analysis
Ready to make an inquiry or request a quote?
Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.
More from Element
Learn more about our laboratories - where they are located; the unique capabilities they have and how they can help you solve your technical and commercial challenges.
Discover perspectives, resources and advice from our world-leading Engaged Experts.
Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Kent is the co-founder of Medical Device Testing Services, acquired by Element in 2017. Kent’s expertise in medical device testing has led to the development of new test instruments, standards and protocols.