Using this method, we determine the extent of screw loosening at the connection between the implant body and abutment by applying cyclic torsional loading. The loosening torque of the abutment screw is measured both before and after the cyclic loading.
DIN EN ISO 14801 describes a test method for fatigue (failure) of single-piece endosseous dental implants of various sizes and designs. The test should, as far as possible, simulate the clinical use of the implant, meaning that specimens representative of the finished product are tested and sterilized as required according to the manufacturer’s instructions. For testing, the specimen is rigidly clamped in the testing machine depending on the design (angled or non-angled abutments) and subjected to a uniaxial load for a defined number of cycles. To create a worst-case scenario, the implant is tilted by 30° during testing.
Additionally, the critical failure point and location are determined, which characterize permanent deformation, loosening of the implant assembly, or fracture of a component. If the implants contain corrosion-prone components or polymers, testing must be conducted in physiological saline solution at 37°C. For all other implant compositions, testing is performed in air at room temperature. All results are documented in a test report according to the standard.
The torsion test according to ISO/TS 13498 evaluates the torsional strength and maximum torque of implants or articulated connecting components of dental endosseous implant systems. This test is especially suitable for evaluating novel joint types, connectors, and new materials. The test is conducted at room temperature in air and should, as far as possible, simulate the clinical use of the implant. That is, specimens representative of the finished product are tested and sterilized as required according to the manufacturer’s instructions.
The maximum torque is determined on at least six identical specimens by clamping the sample into the testing machine and applying torque at a rate of one to ten degrees per minute. The torsional strength is determined at a rotation angle of 2°. During the test, a curve is recorded showing torque as a function of rotation angle, from which the maximum torque and torsional strength can be graphically determined. Broken or deformed parts of the implant are subsequently examined under a low-magnification microscope and documented in the test report.
We offer measurement of the abrasion resistance of metallic thermal spray coatings using a Taber Abraser in accordance with ASTM F1978-18. The coating under investigation is subjected to controlled pressure and abrasion conditions on rotating discs. The specimen, mounted on a rotating platform, turns about a vertical axis against the sliding rotation of two abrasive wheels. One wheel abrades the specimen outward toward the periphery, while the other abrades inward toward the center.
The resulting abrasion marks form a pattern of crossed arcs over an area of approximately 30 cm². After a defined number (2, 5, 10, or 100) of cumulative rotation cycles, the specimens are cleaned in an ultrasonic bath. After each cleaning step, the specimens are dried and weighed. The mass loss serves as a measure of the abrasive wear of the specimen. INNOPROOF is accredited to perform this test.
For testing the shear strength of coatings, ISO 13179-1:2014 specifies dynamic tests that reference the corresponding method in ASTM F1160-14. The coating is applied to the end faces of two cylinders, which are bonded together prior to testing.
The opposing bonded layers are vertically aligned with their contact surface in the loading axis of the testing machine to ensure pure shear loading without bending. The specimen holders are mounted on double Cardan joints to decouple constraint forces.
The ISO standard requires 10 million load cycles for a successful test.
ASTM F1147 specifies a static test setup for determining the tensile or adhesive strength of coatings. The coating is applied to the end face of a cylinder, which is bonded to a second cylinder according to a defined protocol prior to testing.
The opposing bonded layers are axially aligned with their contact surface in the loading axis of the testing machine in order to ensure pure tensile loading. The specimens are mounted on double Cardan joints to decouple constraint forces.
The static testing of coating shear strength is described in ASTM F1044. The joining of the specimens and their alignment in the testing machine correspond to those used in dynamic tests.
The opposing, bonded layers are vertically aligned with their contact surface in the loading axis of the testing machine in order to ensure pure shear loading without bending. The specimen holders are mounted on double Cardan joints to decouple constraint forces.
For fatigue testing of composite sliding nails, INNOPROOF GmbH has established the in-house procedure IP-05-05. The spatial alignment of the sliding nail is based on the testing standard for hip endoprostheses, ISO 7206-4. The load conditions for fatigue testing are defined in consultation with the customer. Typically, tests are performed over 100,000 to 1,000,000 load cycles.
If you have questions regarding physiological loads and expected application durations until complete fracture healing, we are happy to provide consultation.
We offer characterization of the design and mechanical performance of intramedullary nails in accordance with ASTM F1264.
In addition to the mechanical characterization of intramedullary nails, we are also pleased to advise you on correct labeling, packaging, and the content of the manufacturer information to be provided with the product.
We offer various test methods for the mechanical characterization of bone staples in accordance with ASTM F564. Together with you, we select the appropriate test procedures for your bone staples from the following range:
