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경골부 구성요소 내구성 평가를 위한 CoCrMo 합금 물성 분석 및 유한요소 해석 기반 유효성 평가

Mechanical Property Evaluation of CoCrMo Alloy and Finite Element-Based Validation for Durability Assessment of Tibial Components

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This study investigates the fatigue properties of CoCrMo alloy for the durability evaluation of tibial com- ponents in orthopedic implants. Mechanical and fatigue tests were conducted in accordance with ASTM E8 and E606 standards, yielding key material properties such as an average elastic modulus of 234,338 MPa, a yield strength of 947 MPa, and an ultimate tensile strength of 1,230 MPa. These values were applied to finite element analysis (FEA) to predict fatigue life, utilizing a strain-based E–N curve derived from low-cycle fatigue tests. To ensure accuracy, FEA results were validated against physical test data, with the strain prediction error maintained within 1.1%, sat- isfying the ±5% tolerance recommended by ASME V&V 40. Furthermore, the tibial component withstood 10 million cycles under 900 N load in both physical and simulated fatigue tests, demonstrating sufficient fatigue durability. This study confirms that the experimentally derived mechanical properties of CoCrMo alloy can reliably predict the in vivo mechanical behavior of tibial components, and that validated FEA can effectively complement physical testing. These results provide valuable data for medical device design, structural validation, and regulatory approval pro- cesses, enhancing efficiency and credibility in orthopedic implant development

Abstract

This study investigates the fatigue properties of CoCrMo alloy for the durability evaluation of tibial com- ponents in orthopedic implants. Mechanical and fatigue tests were conducted in accordance with ASTM E8 and E606 standards, yielding key material properties such as an average elastic modulus of 234,338 MPa, a yield strength of 947 MPa, and an ultimate tensile strength of 1,230 MPa. These values were applied to finite element analysis (FEA) to predict fatigue life, utilizing a strain-based E–N curve derived from low-cycle fatigue tests. To ensure accuracy, FEA results were validated against physical test data, with the strain prediction error maintained within 1.1%, sat- isfying the ±5% tolerance recommended by ASME V&V 40. Furthermore, the tibial component withstood 10 million cycles under 900 N load in both physical and simulated fatigue tests, demonstrating sufficient fatigue durability. This study confirms that the experimentally derived mechanical properties of CoCrMo alloy can reliably predict the in vivo mechanical behavior of tibial components, and that validated FEA can effectively complement physical testing. These results provide valuable data for medical device design, structural validation, and regulatory approval pro- cesses, enhancing efficiency and credibility in orthopedic implant development

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