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"신뢰성 평가"

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"신뢰성 평가"

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A Study on the Practical Application of ASME V&V 40 Standard for Computational Modeling and Simulation (CM&S) in Medical Devices
Ju-Yeon Lee, Tae-Hee Lee, Ju-Seon Lee, So Hee Kim, Hee Seon Heo, Dong Hyun Go, Hyeon Jeong Kim, Hae Dae Park, Su-Kyoung Lee
J. Korean Soc. Precis. Eng. 2026;43(5):505-515.
Published online May 1, 2026
DOI: https://doi.org/10.7736/JKSPE.025.134
The increasing use of computational modeling and simulation (CM&S) in the medical device sector has heightened the need for ensuring simulation credibility. The ASME V&V 40 standard offers a structured framework for assessing credibility, consisting of 23 factors divided into three main categories: Verification, Validation, and Applicability. However, practical guidance for implementing these factors is still scarce. This study systematically reviewed and analyzed ten CM&S-related publications in the medical device field that utilized the ASME V&V 40 framework. It examined how each publication addressed the credibility factors and compared their implementation methods, evaluation criteria, and credibility levels. From this comparative analysis, we developed implementation strategies focused on credibility factors, field-specific characteristics, and model risk levels in real-world regulatory and development contexts. Key considerations for the practical application of each factor were identified, and recommendations for effective implementation were proposed. These findings offer practical guidance for ensuring credibility in CM&S-based medical device development, performance evaluation, and regulatory processes. By clearly demonstrating the applicability of the ASME V&V 40 framework, this work provides valuable direction for related industries and research institutions, aiming to improve CM&S credibility and promote its broader adoption in healthcare.
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Article
Development of Bending Lifetime Tester for Flexible OLEDs
Ji-Yeon Han, Jae-Hyun Lee
J. Korean Soc. Precis. Eng. 2018;35(4):451-456.
Published online April 1, 2018
DOI: https://doi.org/10.7736/KSPE.2018.35.4.451
The applicability of flexible OLED devices has been expanding to rollable or foldable displays and lighting. At this time, a system to measure the durability of flexible OLEDs needs to be developed to successfully launch flexible OLEDs in future electronic devices. In this paper, we develop a bending lifetime tester to measure the performance of flexible OLEDs by measuring the luminance of the device in real-time during the bending test. A fixed distance between the bent OLEDs and detector during the bending test improves the accuracy of the measured brightness in real time. This bending tester can measure the lifetime of flexible OLEDs with a mean deviation of less than 0.23% over a temperature range of -30 to 80℃. This performance is sufficient to measure the accelerated lifetime test of flexible OLEDs for reliability engineering.
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