Tests According to ASTM Standards
ASTM F1223 – AP Tensile Test
Measures the anterior-posterior (AP) pull-out strength of orthopedic implants. This test determines the risk of rupture or tearing by evaluating the tensile strength of spinal implants.
ASTM F1223 – ML Shear Test
Tests the medio-lateral (ML) shear strength of orthopedic implants. The resistance of the implant against forces coming from the side is measured.
ASTM F1223 – Rotational Test
Evaluates the durability of implants against rotational forces. This test measures the resistance of the implant against bending or buckling forces it is exposed to in the rotation axis.
ASTM F1800 – Tibial Fatigue Test
Tests the fatigue durability of the tibial components of knee prostheses. The long-term durability of the prosthesis is evaluated by applying repeated loads.
ASTM F1814 – Static Test
Measures the durability of the tibial components of knee prostheses under static loads. It tests whether the prosthesis deforms under a specific load or the risk of breakage.
ASTM F2003-02 – Accelerated Aging Test
Simulates the aging effects of medical devices over time under accelerated conditions. Measures chemical and physical property changes based on a 14-day aging period.
ASTM F2722 – Rotational Stop Test
Tests the rotatability of the implant up to a certain angle and the effectiveness of the stop mechanism during this movement. Simulates safe rotation.
ASTM F2724 – Dynamic Separation Test
Tests the separation tendencies of implants under dynamic conditions. Evaluates the risk of dislocation during loading/unloading.
ASTM F2777 – Dynamic Insert Test
Measures the durability and movement stability of implant components such as knee prostheses under dynamic insertion conditions.
Tests According to ISO Standards
ISO 14242-1
Hip Joint Prosthesis Wear
Measures wear performance under repeated movements and loads by simulating natural joint movements.
ISO 14243-1
Knee Joint Prosthesis Wear
Evaluates the effects of axial force, AP force, and torsional moment under physiological conditions.
ISO 14243-3
Gravimetric Measurement
Measures the long-term durability of the prosthesis by determining the amount of wear by weight loss method.
ISO 14243-5
Kinetic and Kinematic Wear
Dynamically tests the wear effects of the prosthesis in different movement and loading situations.
ISO 17853
Particle Analysis
Performs detailed analysis of polyethylene wear particles with SEM microscopy and statistical methods.
Sterile Barrier and Packaging
Sterile Barrier Compatibility Tests
Evaluates the compatibility of sterile barrier systems of medical devices with moist and dry heat sterilization. Determines the sterility protection capacity of packaging materials.
Standards: DIN EN ISO 11607-1, DIN EN 868-5Heat Sealed Joint Stability Test
Tests the seal stability in plastic laminate film. Checks color change, peeling properties, and storage/transport suitability.
Standards: DIN EN ISO 11607-1, DIN EN 868-5, DIN EN ISO 11140-1Protective Equipment and Textiles
Mechanical Durability Tests
Measures the wet/dry penetration resistance of microorganisms for surgical gowns.
Respiratory Protective Device Test
Measures protection and filtration efficiency of filtering half masks against particles.
Protective Clothing Tests
Measures mechanical resistance of clothing against microorganism penetration under pressure.
Bursting Strength Test
Strength test showing textile materials without bursting under high pressure.
Liquid Proofness Test
Analyzes infection risk by determining the liquid-proof property of surgical clothing.
Particle Evaluation Test
Measures sterile environment compatibility by analyzing particles released from textile surfaces.