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ISO 16402 Acrylic resin cement Flexural fatigue testing

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ISO 16402:2008, Implants for Surgery - Acrylic Resin Cement - Flexural Fatigue Testing of Acrylic Resin Cements Used in Orthopaedics, is an international standard dedicated to testing the flexural performance of acrylic resin bone cement applied in orthopedic surgeries. It plays a critical role in ensuring the long-term mechanical stability of bone cement, which is essential for the success of orthopedic implants.


Core Scope and Objectives

  1. Applicable Scope: The standard is exclusively applicable to resin cements based on poly(methacrylic acid esters) — the acrylic resin bone cement commonly used in orthopedics to fill the gaps between implants and bones. It should be noted that it does not address the safety hazards to patients or medical staff during the use of the cement, nor does it apply to other types of surgical cements.


  2. Core Objectives: Its primary purpose is to standardize the test methods for acrylic resin bone cement in the laboratory. It assesses the mechanical properties of polymerized bone cement under static and cyclic loads by combining quasi-static flexural tests and flexural fatigue tests. This helps manufacturers optimize product formulas, enables quality inspection agencies to conduct standardized evaluations, and provides reliable mechanical performance data for regulatory certification of orthopedic implants.



Bone Cement Four-Point Bending Fatigue Test is primarily used to evaluate the fatigue performance of bone cement materials under four-point bending conditions. Specifically, it can conduct mechanical performance tests, such as fatigue durability and lifespan, on specimens of bone cement, biomaterials, surgical implant materials, and medical materials. By simulating real-world stress conditions, the tester assesses the bending strength, fatigue life, deformation characteristics, and performance of bone cement under various environmental conditions. These test results are crucial for ensuring the reliability and safety of bone cement in practical applications, aiding in product design optimization, production process improvement, and overall product quality enhancement. 


Sample preapare: A four-point bending test was made on bone cements. The samples were cyclically loaded at a stress level of 20 MPa at a frequency of 4 Hz. The different cements were mixed either by hand or mechanically with or without a 0.15-bar vacuum. Mechanical mixing in a vacuum improved all three cements, and was the best of all the tested mixing techniques. Simplex P showed the best fatigue properties regardless of mixing technique.


Standard: ISO 16402:2008

Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics


ASTM F2118-14

Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

The ISO 16402, ASTM F2118 standard specifies the test procedures for determining the fatigue characteristics of resin-based bone cement made from polymethyl methacrylate, employing rectangular bar samples and conducting four-point bending tests under quasi-static or cyclic loading conditions to obtain the bending strength or fatigue life of the samples.We provide professional testing jigs (in a water bath environment) and precise and effective testing solutions (SOP) to assist in the analysis of the mechanical properties of bone cement.






Test Procedures

The standard consists of two key test modules, which are carried out sequentially to comprehensively evaluate the flexural performance of bone cement:

  1. Quasi-static Flexural Test: This test is conducted first using a small four-point bending fixture. It mainly measures the basic flexural mechanical properties of the bone cement, such as flexural strength and flexural modulus, laying the foundation for setting parameters for the subsequent fatigue test. The loading method adopts a quasi-static mode to avoid test errors caused by sudden load changes.

  2. Flexural Fatigue Test: After the quasi-static test, the fatigue test is performed using the same four-point bending fixture. Two cyclic loading test methods are specified in the standard. During the test, a constant-amplitude cyclic load is applied to the specimen, and the stress level and the corresponding number of cycles until the specimen fails are recorded. Finally, a stress-cycle (S-N) curve is generated to intuitively reflect the fatigue resistance of the bone cement.


Application Significance: In the R&D stage, it can help developers compare the performance of different bone cement formulations and optimize product designs. In mass production, it serves as a standardized quality control tool to ensure consistent fatigue performance of products in each batch. For regulatory authorities, the test data based on this standard is an important basis for reviewing orthopedic implant-related products.

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