Biomechanical Tests According to ASTM Standards
ASTM F1223 – AP Tensile Test
Measures the tensile strength of orthopaedic implants in the anterior-posterior (AP) direction. This test assesses the tensile strength of spinal implants to determine the risk of rupture or tear.
ASTM F1223 – ML Shear Test
It tests the shear strength of orthopaedic implants in the medio-lateral (ML) direction. The resistance of the implant to forces from the side is measured.
ASTM F1223 – Rotational Test
It evaluates the durability of implants against rotational forces. This test measures the implant’s resistance to bending or buckling forces in the axis of rotation.
ASTM F1800 – Tibial Fatigue Test
Tests the fatigue durability of 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. Tests whether the prosthesis deforms or fractures under a given load.
ASTM F2003-02 – Accelerated Ageing Test
Simulates the ageing effects of medical devices over time under accelerated conditions. The test assesses how the chemical and physical properties of the material change over a 14-day ageing period. Up to 10 samples are tested (maximum volume 3 litres).
ASTM F2722 – Rotational Stop Test
Tests the rotability of the implant up to a certain angle and the effectiveness of the stop mechanism during this movement. Simulates safe rotational movements of the implant.
ASTM F2724 – Dynamic Weathering Test
Tests the tendency of implants to separate under dynamic conditions. Assesses the risk of implant dislodgement or separation during loading and unloading operations.
ASTM F2777 – Dynamic Insert Test
Tests the durability of implant components such as knee prostheses under dynamic insertion conditions. Measures whether the prosthesis remains stable during movement.
Biomechanical Tests According to ISO Standards
ISO 14242-1 – Hip Prosthesis Abrasion Test
Tests the wear performance of hip prostheses under repetitive movements and loads. This test simulates the natural movements of the hip joint and measures the amount of wear on the prosthesis.
ISO 14243-1 – Knee Prosthesis Wear Test
It evaluates the wear performance of knee prostheses under physiological conditions. The effect of loads such as axial force, anterior-posterior force and torsional moment are tested.
ISO 14243-3 – Gravimetric Abrasion Measurement Test
Determines the amount of wear in knee prostheses by gravimetric method (weight loss measurement). It evaluates the durability of the prosthesis by measuring the mass loss that occurs during wear.
ISO 14243-5 – Kinetic and Kinematic Abrasion Test
Tests wear of knee prostheses under kinetic and kinematic conditions. Evaluates the wear effects of the prosthesis in different movement and loading situations.
ISO 17853 – Particle Analysis (Polyethylene)
It analyses polyethylene wear particles. It includes chemical preparation of the test fluid, microfiltration down to 0.05μm, analysis of filters by SEM (Scanning Electron Microscope), image analysis of wear particles and statistical evaluation processes.
Compatibility Tests for Sterile Barrier and Packaging Systems
Evaluates the compatibility of sterile barrier systems of medical devices for sterilisation by moist heat and dry heat. These tests determine whether packaging materials can maintain sterility.
Standards: DIN EN ISO 11607-1, DIN EN 868-5
Heat Sealed Joint Stability Test
It tests the stability of heat-sealed joints in plastic laminate film. The test evaluates indicators such as discolouration, checks the peeling properties of paper-plastic laminates and the suitability of packaging during storage and transport.
Standards: DIN EN ISO 11607-1, DIN EN 868-5, DIN EN ISO 11140-1
Mechanical Durability Tests
For surgical gowns and drapes, it evaluates the penetration resistance of microorganisms in wet and dry conditions. These tests determine whether textile materials used during surgery provide hygienic protection.
Standards: ISO 22610:2018 (wet), EN ISO 22612:2005 (dry)
Respiratory Protective Device Testing for Protection Against Particulates
Evaluates the ability of filtered half masks to protect against particles. Measures the filtration efficiency of the masks and determines the capacity to protect the wearer from hazardous particles.
Standards: EN 149:2001+A1:2009
Protective Clothing Tests
Measures the mechanical strength of protective clothing in the surface direction under pressure. It tests whether medical clothing is resistant to the penetration of microorganisms.
Standards: ISO 14126:1999/AC:2002
Bursting Resistance Test
It is a test to measure the explosion resistance of textile materials. It tests the explosion resistance of medical clothing and drapes under high pressure.
Standards: EN ISO 13938-1:2019
Liquid Proof Test
Tests how resistant medical textiles are to fluids. Determines the liquid repellency of surgical garments, which is critical to reduce the risk of infection.
Standards: EN ISO 811:2018
Particle Evaluation Test
Analyses particles released from textile surfaces. This test measures the capacity of medical garments or drapes to maintain a sterile environment during surgery by assessing particle release.
Standards: EN ISO 9073-10:2004