ASME V&V 표준기반 인공무릎관절 컴퓨터 모델의 신뢰성 검증 및 접촉특성 평가
Assessment and Credibility Verification of Contact Pressure Properties in Artificial Knee Joints Using the ASME V&V 40 Standard-Based Computational Model
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초록
This study aimed to develop a computational model for evaluating contact pressure and contact area in artificial knee joints based on ISO 21536 standards and to verify its reliability using the ASME V&V 40 framework. A finite element analysis (FEA) model was developed to simulate various flexion angles and rotational conditions, including 0°, 15°, 30°, 60°, 90°, and 110°, to assess the knee implant's performance under different load conditions. The simulation results showed high agreement with physical test results, with error rates within ±5%, meeting the strict credibility criteria set by ASME V&V 40. The contact pressure satisfied the equivalence criteria of 52.9 MPa, and the contact area met the equivalence criteria of 95 mm² across all conditions. The study confirms that simulation models can provide reliable data comparable to bench tests, reducing time and cost in knee implant development and regulatory approval processes.
Abstract
This study aimed to develop a computational model for evaluating contact pressure and contact area in artificial knee joints based on ISO 21536 standards and to verify its reliability using the ASME V&V 40 framework. A finite element analysis (FEA) model was developed to simulate various flexion angles and rotational conditions, including 0°, 15°, 30°, 60°, 90°, and 110°, to assess the knee implant's performance under different load conditions. The simulation results showed high agreement with physical test results, with error rates within ±5%, meeting the strict credibility criteria set by ASME V&V 40. The contact pressure satisfied the equivalence criteria of 52.9 MPa, and the contact area met the equivalence criteria of 95 mm² across all conditions. The study confirms that simulation models can provide reliable data comparable to bench tests, reducing time and cost in knee implant development and regulatory approval processes.