• Journal of the Korean Society for Precision Engineering
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• v.27 no.5
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• pp.36-47
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• 2010

The Korean Railroad Research Institute (KRRI) has developed the rubber tired AGT system (Model: K-AGT) between 1999 and 2005. The K-AGT is a light rail transit system does not require a driver and generally operates on an elevated railroad for transporting passengers. Accidents caused by driverless vehicles can severely affect social confidence, safety and economy therefore, it is very important to minimize the occurrences of such faults, and to accurately perform detailed maintenance tasks and thoroughly investigate the cause of any repeated failures. This research develops the web-based Preventive Maintenance (PM) system for the KAGT train system. The framework of the PM system is based on performing a reliability analysis and a failure mode effects analyses (FMEA) procedure on all the sub-systems in the K-AGT system. Out of the devices that have a low reliability, the high failure ranked devices are included high in the list for performing the overall maintenance plans. Through registration of historical failure data, the reliability indexes can be updated. Such a process is repeated continuously and can achieve very accurate predictions for device operational life times and failure rates. Therefore, this research describes the development of the overall PM system consists of a reliability analysis module, a failure mode effect analysis module, and maintenance request module.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.