• 한국가스학회지
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• 제13권1호
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• pp.52-60
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• 2009

본 논문에서는 Risk-based design개념을 반영하여 체계적인 설계방향을 제시하고 현존하는 법에 더욱 안전한 방향으로 법안이나 규격을 수정할 수 있는 방안을 제시하려고 한다. 안전설계 부분의 초기설계 집중도 및 수준을 향상시키기 위하여 설계 초기단계에서부터 체계화된 안전설계 요소의 정보를 제공할 수 있는 새로운 Advanced Safety Analysis Table(ASAT)을 개발하였다. 또한 ASAT를 토대로 공정 트러블에 따른 안전장치를 선택하는 방법에 대한 가이드라인을 개발하였다. 개발된 ASAT, 공정 트러블에 따른 안전장치를 선택방법의 사례 연구로 NCC(Naphtha Cracking Center) 공정의 PGC(Process Gas Compressor)에 대한 ASAT를 구축하고 공정 트러블에 따른 안전장치를 선택한 결과를 분석하였다.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.363-376
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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.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• 대한의용생체공학회:의공학회지
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• 제44권2호
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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.

• 한국안전학회지
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• 제32권1호
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• pp.121-127
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• 2017

Recently, many patients in a hospital are threatened life by fire disaster. Because many patients like vulnerable people have more evacuation problem than ordinary person. So a patient who can escape by oneself with walking assistance device like crutches or wheelchair and another patient who can't escape by oneself are should be supported safety technologies and service. Earlier research of 'hospital evacuation' led by actual experiments or computer evacuation simulation. Actual experiment is effective to gain credibility of result but it is difficult for patients to experiment repeatedly and it requires consideration for spatial problem and economic problems. Although computer evacuation simulation have been used to solve these problems, almost have concluded only results based on velocity without evacuation device. In this study, evacuation results with support device application or not are analysed used by computer evacuation simulation based on MAS(Multi Agent System). As a result, it is drawn through proof of efficiency of evacuation device in the vertical space like stairs that can improve the evacuation plan for vulnerable people in the hospital.

• 대한의용생체공학회:의공학회지
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• 제36권5호
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• pp.162-168
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• 2015

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

• 한국인터넷방송통신학회논문지
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• 제9권6호
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• pp.135-139
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• 2009

어선의 안전을 실시간으로 모니터링하고 위험요소가 발생했을 경우에 사용자에게 이를 경보하고 통보해줄 수 있는 장치에 대한 필요성이 크게 대두되고 있다. 위험요소를 감지하는 다기능 센서를 사용하기 위해서 임베디드 모듈에서는 Device driver와 Application program을 구현해야 하는 문제가 있다. 본 논문에서는 Device driver와 Application program의 구현 없이 다기능 센서의 입출력 데이터를 관리 및 처리하기 위해서 PIC18F를 이용하여 센서부의 하드웨어 설계 및 제어프로그램 구현을 하였다. 센서의 동작에 따라 데이터를 출력하는 동작 확인을 통하여 성능검증을 하였다.

• 산업융합연구
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• 제17권4호
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• pp.125-129
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• 2019

자전거를 이용하는 사람들의 수가 증가함에 따라 자전거 사고의 수도 증가하고 있습니다. LED 조명을 사용하면 자전거를 탈 때 자전거 사고를 최대 11 % ~ 44 %까지 줄일 수 있습니다. 자전거의 헤드라이트는 자전거 라이더의 반대쪽에 노출 효과를, 미등은 후면 자전거 라이더에 노출 효과를 제공하여 안전성을 향상시킵니다. 본 연구에서는 제어 버튼 신호에 응답하여 LED에 의한 방향 전환을 표시 할 수 있는 자전거 안전장치를 구현 하였다. 이 신호는 고정 된 시간 동안 자전거의 페달과 휠에 장착 된 LED 조명을 모듈 유형의 발광 또는 깜박임으로 만듭니다. 야간에 자전거를 타는 사람이 자전거를 타는 경우 LED를 사용하여 안전을 향상시킬 수 있는 페달의 자전거 보조 장치가 본 연구에서 개발되었습니다. 무선 통신 기술을 적용한 자전거 안전장치는 미래에 에너지, 환경 및 안전과 같은 사회적 문제를 해결하기 위한 대체 기술이 될 것으로 예상됩니다.

• 재활복지공학회논문지
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• 제11권4호
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• pp.287-297
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• 2017

본 연구는 의료기기 안전성에 관한 의료인들의 인식(지식, 태도)과 행동에 관한 기초현황을 파악하여 보고, 직종 간 차이를 평가해보기 위한 탐색적 조사연구이다. 인천광역시에 소재한 900병상 규모의 상급종합병원을 대상으로 설문지를 배포하여 220명의 응답 자료를 분석에 사용하였다. 연구결과, 연구대상 의료인들은 대체적으로 의료기기 종류에 따른 잠재적 위험성에 대한 인식이 갖춰져 있고, 의료기기 안전성 교육의 필요성을 느끼고 있었다. 또한 의료진들의 직종 간 의료기기 안전성에 관한 인식의 차이를 살펴봤을 때, 등급 높은 의료기기를 주로 사용하지만 의료기기 안전에 관한 인식이 가장 낮은 전공의를 대상으로 하는 의료기기 안전교육의 필요성이 크다는 것을 알 수 있었다. 향후 전국규모의 연구를 통하여 자료의 질을 향상하고 결과의 수준을 높이며, 이를 바탕으로 의료기기 안전성 관리에 있어 정책적, 교육적 기반으로 활용할 필요가 있다.

• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• Safety and Health at Work
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• 제8권1호
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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.