Osteosynthesis

Test methods marked with “*” sign are within the scope of the accreditation.

According to this standard, performance of angled devices used in the surgical internal fixation is determined. Static and dynamic tests are carried out within this scope.

Measuring mechanical properties of metallic screws used in bone  are determined with methods in this standard.

Performance related mechanical properties of external fixation devices are determined with the methods defined by this standard.

Performance related mechanical properties of bone plate used in the surgical internal fixation are determined with the methods defined by this standard.

Performance related mechanical properties of intramedullary fixation devices are determined with the methods defined by this standard. In this context, static, dynamic and torsion tests are performed for both nail and locking screws.

Mechanical characterization of bioabsorbable plates and screws used in orthopedic internal fixation is determined within the scope of this standard.

This standard provide methods for characterization of the design and mechanical function of metalic staples used for internal fixation of the muscular skeletal system. Bending, pull out, dynamic and tissue fixation strength tests are carried out within this scope.

Labiotech PI-002 comprises two test methods. The purpose of the first test method is to determine tensile strength of cables. The purpose of the second test method defined in Labiotech PI-002 is to determine the maximum tensile force that swage can endure.

Labiotech PI-012 specifies torsion and pullout test for PEEK Screw.

The purpose of this test method is to determine bending properties of clavicula plates fixed to bone model.

This method specifies torsion and pullout test methods for intramedullary nails with talon/claw mechanism. The purpose of the torsion test is to determine required torque for talons to penetrate bone model. The purpose of the pullout test is to determine axial pullout strength of the nail while its talons are

Schanz pins of external fixation devices are tested according to ASTM F1541 test standard. However, it is not specified any test method for schanz pins to evaluate their long-term biomechanical performance in ASTM F1541. Labiotech PI-018 specifies fatigue test method for schanz pins.

Test method for locking screws under dynamic loading condition is specified in ASTM F1264. However, it is not specified any test method for static loading condition to determine yield strength of the device. Labiotech PI-021 specifies static bending test for locking screws.