ISO 16402 Flexural Testing of Acrylic Resin Cements Used in Orthopaedics
During the implantation process, bone cements are used to fill the space between the implant and the bone, and their long-term mechanical stability is essential for success of the implant. By undertaking static and cyclic loading, the mechanical performance of these bone cements can be established.
ISO 16402 ‘Implants for surgery – Acrylic resin cement - Flexural fatigue testing of acrylic resin cements used in orthopaedics’ provides a guideline for flexural testing of these cements in a laboratory situation. It consists of a method for both quasi-static bend testing and flexural fatigue.
A miniature 4-point bend fixture is used within into a fluid bath filled with Ringer’s solution and maintained at 37° C. After a quasi-static bend test is performed, fatigue testing is carried out to generate a Stress level/Number of cycles (S/N) curve.
We recommend the use of either an ElectroPuls™ All-Electric Dynamic Test Instrument or 8870 servohydraulic fatigue test system for undertaking both the quasi-static and the cyclic loading of these bone cements.
We recommend that you review the standard to fully understand its requirements.
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Instron® has considerable experience of mechanical testing in orthopaedics: from basic static testing of raw materials, to impact loading of joint components, through to complete simulation for evaluating the fatigue and wear properties in vivo. Through every phase of implant development, our solutions meet a vast array of demands found within the orthopaedics field. These include hip and knee implants, spinal devices, and medical devices for trauma and osteosynthesis.
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