• Journal of Biomedical Engineering Research
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• v.44 no.2
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• pp.99-108
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.

• Journal of the Korean Society of Safety
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• v.26 no.5
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• pp.13-16
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• 2011

The vibration and shock of the opto-electronic protective device was induced mechanical failure or fail to work correctly. In order to identify the exciting frequency components of vibration and shock, vibration signals are measured and analyzed from the mechanical power press. In addition, the modal test for the opto-electronic protective device was performed to investigate the dynamic characteristics. Some FEM simulations were carried out and then anti vibration mount was made for opto-electronic protective device. Based on the results of simulations, some kind of rubber mounts were tested to demonstrate the reduction of vibration and shock. It was verified by the test that a considerable amount of vibration and shock were reduced.

• Proceedings of the Safety Management and Science Conference
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• 2009.04a
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• pp.523-529
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• 2009

The ACF(Anisotropic Conductive Film) is used for bonding Drive IC and OLED display device panel. If ACF bonding process is problem, a malfunction of line defect can occur. Because electric resistance increase between the panel and drive IC after a period of time, drive IC can not supply enough current to the panel. This paper is studied on a method of test for line defect.

• Safety and Health at Work
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• v.8 no.1
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• pp.59-66
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• 2017

Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.147-152
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• 2022

This research is to measure real-time temperature distribution inside a tissue-mimicking phantom for the safety and effectiveness evaluations of focused ultrasound (FUS) device capable of linear scanning stimulation. Since the focusing area of the FUS stimulation device is smaller than diameter of conventional thermal probe and keeps moving, it is impossible to monitor temperature distribution inside the phantom. By using the phantom with a thin film temperature sensor array inserted, real-time temperature change caused by the FUS device was measured. The translation of the measured temperature peak was also tracked successfully. The present phantom had been experimentally proven to be applicable to validate the performance and safety of the therapeutic ultrasound devices.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• International Journal of Safety
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• v.7 no.2
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• pp.27-30
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• 2008

In the 21st century, safety issues in the strained silicon industry, such as dislocation injection, should be carefully considered. This is because a microelectronic device usually contains sharp features (e.g., edges and corners) that may intensify stresses, inject dislocations into silicon, and ultimately cause the failure of the device. In this paper, critical residual stresses in various strained structures are calculated. It is confirmed that this model correctly predicts trends and the order of magnitude of critical residual stresses.

• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Journal of the Korean Society of Safety
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• v.16 no.2
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• pp.57-62
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• 2001

In order to analyze the mechanism of semiconductor device damages by ESD, this paper adopts a new charged-device model(CDM), field-induced charged nudel(FCDM), simulator that is suitable for rapid routine testing of semiconductor devices and provides a fast and inexpensive test that faithfully represents ESD hazards in plants. The high voltage applied to the device under test is raised by the fie]d of non-contacting electrodes in the FCDM simulator. which avoids premature device stressing and permits a faster test cycle. Discharge current md time are measured and calculated The FCDM simulator places the device at a huh voltage without transferring charge to it, by using a non-contacting electrode. The only charge transfer in the FCMD simulator happens during the discharge. This paper examine the field charging mechanism, measure device thresholds, and analyze failure modes. The FCDM simulator provides a Int and inexpensive test that faithfully represents factory ESD hazards. The damaged devices obtained in the simulator are analyzed and evaluated by SEM Also the results in this paper can be used for to prevent semiconductor devices from ESD hazards.

• Journal of radiological science and technology
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• v.39 no.2
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• pp.263-271
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• 2016

The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.