ASTM F1044 Shear Testing of CaP and Metallic Coatings

The ASTM F1044 standard recommends test methods to determine the shear strength of calcium phosphate (CaP) or metallic coatings on dense metal implant surfaces. To gain FDA approval, manufacturers must prove a medical device can perform safely and reliably when under the conditions in the human body, such as shear loading.

The Need for Shear Testing

To anticipate how the device handles in vivo shear loads, ASTM created standard F1044 for testing the shear strength of Calcium Phosphate and metallic coatings. Manufacturers turn to third parties such as the ATS FoC for quality testing from accredited facilities. We operate multiple A2LA-accredited medical device testing labs. Our experts can help manufacturers make redesign choices for life-changing medical devices and test product compliance with industry standards and FDA regulations, such as ASTM F1044.

ASTM F1044 Testing Methods

ASTM F1044 outlines two methods for testing coatings: aligned interface testing for metallic and calcium phosphate coatings and lap shear testing for metallic coatings. In both methods, lab technicians apply a constant shear load until the coating separates completely from the substrate surface.

We can calculate shear strength based off the mechanical properties in a coating material and the adhesive that binds the coating to the substrate surface. Manufacturers may apply adhesives as a thin film or cement or forego the use of adhesives by binding the two materials with thermomechanical means.

Our clients can use the rigorous testing results to decide the next steps for their product. Manufacturers may redesign the product with a new coating, adhesive method, adhesive material, or substrate material so the coating does not separate from the implant. If satisfied with the device’s strain strength, manufacturers may decide to submit the medical device to the FDA for premarket approval.

We perform dynamic testing in a saline, temperature-controlled environment until device failure or the 10,000,000th cycle. We can adjust dynamic tests to simulate common loading conditions: flexion, extension, lateral bending, and axial rotation.

Medical Device Testing with the ATS FoC

ATS offers elite customer service and a quick turnaround rate to empower our clients to make effective business decisions and maintain standard and regulatory compliance. Capable of reaching clients both on-site and remotely, our experts provide insight and precision in all consulting engineering, calibration, inspection, and testing services. We hold multiple ISO/IEC 17025 accreditations in calibrations and mechanical testing, chemical testing, electrical testing, and nondestructive testing.

Let the ATS FoC support your medical device testing needs. Call +1 (888) 287-5227 or submit the request form on this page to schedule ASTM F1044 compliance testing with the ATS FoC.

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