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KMID : 1142220210160020193
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.193 ~ p.198
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The Considerations for Evaluating Medical 3D Modeling Software Using Phantoms
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Park Jong-Seon
Yeon Chan-Mi
Kim San
Park Chang-Won
Lee Jae-Won
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Abstract
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Patient-matched medical devices are manufactured by stacking materials after obtaining 3D digital images using medical images. As the modeling process is the first step that can affect a 3D printed medical device's accuracy, it is crucial to ensure the quality of the modeling step. Still, there is no standardized way to evaluate whether a product designed with 3D modeling software matches a custom-made product. Based on the domestic and overseas 3D printing patient customized medical device policies, international standards, and guidelines, it is considered that the accuracy and precision of product dimensions and tolerance errors are important to check whether the product and 3D models match each other. It is crucial to accurately express the shape by optimizing the product resolution, and geometric requirements must be satisfied to prevent errors in the STL file. Dimensional and geometrical tolerances by geometric methods such as length dimension, angular dimension, straightness, flatness, roundness, cylindricity, parallelism, perpendicularity, and position can be considered factors for evaluating 3D printing modeling software. This study's consideration of medical 3D software using phantom investigated is expected to contribute to preparing a standardized medical 3D modeling software performance evaluation method.
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KEYWORD
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Medical 3D Printing, Modeling, Software, Phantom
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