• Journal of Biomedical Engineering Research
• /
• v.42 no.3
• /
• pp.86-93
• /
• 2021

Purpose: The purpose of this study is to find out the cognizance of medical device safety information (MDSI) monitoring in the hospital and oriental hospital workers, and the different aspect of MDSI between oriental medical devices and medical devices. Methods: The survey was performed both in the oriental medicine hospital and general hospital. The survey had 16 items; 2 items basic questions, 5 items in the awareness of MDSI, 5 items in the education of MDSI, 4 items in the necessity of defining oriental medical devices and differences between general and oriental medical devices. A total of 120 hospital worker were participated; 60 oriental medicine hospital workers and 60 general hospital workers. They had worked in the oriental medicine or general hospital associated with 'Medical Device Safety Monitoring Center, Dongguk University Ilsan Hospital' in 2019 and 2020. Results: The cognizance of MDSI was high both in oriental medicine hospital and general hospital workers and there were no significant differences between oriental medicine and general hospital workers. When we divided the hospital workers into the senior workers who had worked for over 3 years and junior workers for less than 3 years, the senior workers had higher awareness of MDSI than junior workers. However, the cognizance of education of MDSI was high which was not different between senior and junior workers. Both hospital workers thought that it was necessary to define oriental medicine device legally and the oriental medical device might have low risk and less side effect than medical device. Conclusion: The cognizance of MDSI was high and there was no significant differences between oriental medicine and general hospital workers. Because the senior hospital workers had higher recognition of MDSI, we need to provide the continuous education program for junior hospital workers. Although oriental medical device are thought to be safer than medical device, we need to have a legal definition.

• Current Optics and Photonics
• /
• v.1 no.5
• /
• pp.500-504
• /
• 2017

In this paper, we developed a temperature measurement system based on an infrared temperature imaging module for thermal safety verification of a plasma skin treatment device (PSTD). We tested a pilot product of the low-temperature PSTD using the system, and the temperature increase of each plasma torch was well-monitored in real-time. Additionally, through the approximation of the temperature increase of the plasma torches, a certain limitation of the plasma treatment time on skin was established with the International Electrotechnical Commission (IEC) guideline. We determined an appropriate plasma treatment time ($T_{Safe}$ < 24 minutes) using the configured temperature measurement system. We believe that the temperature measurement system has a potential to be employed for testing thermal safety and suitability of various medical devices and industrial instruments.

• Journal of the Korean Society of Safety
• /
• v.24 no.6
• /
• pp.50-54
• /
• 2009

Ionizer is used for improving manufacturing process and reducing inferior goods in the clean room. As a general rule, neutralization of the electrostatic charge is most important to make TFT-LCD, PDP and OLED. Pulse AC-static eliminator with output voltage of about 10.5kV has been used these days as neutralization device. But this device has a problem with lower performance which was caused by particles-adhesion on the electrode when it has been used for a long time. So we studied to solve the problem with lower performance using high Frequency(72kHz) static eliminator which was produced by Piezo transformer device, and compared Pulse-AC type with Piezo-electronic device such as decay time and ion balance for 10 weeks periods. As a result of this study, we found that Piezo transformer device has been maintained normal condition for 10 weeks. Also, we made the rule by this study, normally Piezo transformer device has to clean the electrode during every 11th weeks.

• Journal of the Korean Society of Safety
• /
• v.17 no.3
• /
• pp.22-29
• /
• 2002

The safety device of infrared type for dangerous machine being used currently has a harmful effect on human's eye and skin. In this paper we explain about the characteristics of lasr source and analyze the amount of harmfulness on human's eye by simulation method. We used the datas given by ANSI in this simulation.

• Journal of the Korean Institute of Gas
• /
• v.10 no.3 s.32
• /
• pp.54-59
• /
• 2006

A safety device with shut-off function was developed for preventing intentional accidents that might happen by separating of cutting hoses connected to pressure regulators used in residential LP gas facility. For the verification of function and field adaptability, the safety device with shut-off function was tested in the state of joining the device to the regulator and a field test was carried out at home. This study shows that, at the inlet pressure of 0.07-1.56 MPa, the device shuts off the gas within the 5m length of hose regardless of the installation condition of the regulator. The shut-off flow rate increases in the order of perpendicular upward, horizontal and perpendicular downward. From the results of the field tests carried out at home for 5 months, there appears no problem using a gas range or a boiler. If the developed shut-off device is commercialized and distributed in the market the intentional accidents occurred by cutting or separating hoses can be prevented remarkably.

• Journal of the Korean Society of Safety
• /
• v.30 no.6
• /
• pp.26-33
• /
• 2015

This study suggests systematic procedures to improve safety policies on prevention of industrial accidents associated with industrial machines and devices. Specifically, new method of cause analysis of industrial accidents associated with industrial machines and devices is suggested and the related accident data are re-analyzed. Effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, safety device regulation and safety inspection of industrial machines and devices are also analyzed. Based on those analysis results, transition from the current user-oriented safety device regulation to more balanced direct regulations on both manufacturer and user is suggested. Together with severity and frequency of industrial accidents, unit severity and unit frequency need to be taken into account to further assess the risk associated with a particular industrial machine or device. Balance between safety regulations will be realized by proper adjustment of lists of safety certification and inspection, and certification and inspection standards. This will also guarantee the maximum benefit over cost in such safety regulations.

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

• Journal of the Korean Society of Safety
• /
• v.17 no.4
• /
• pp.94-100
• /
• 2002

As the use of automatic handling equipment for sensitive semiconductor devices is rapidly increased, manufacturers of electronic components and equipments need to be more alert to the problem of electrostatic discharges(ESD). In order to analyze damage characteristics of semiconductor device damaged by ESD, this study adopts a new charged-device model(CDM), field-induced charged model(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. High voltage applied to the device under test is raised by the field of non-contacting electrodes in the FCDM simulator, which avoids premature device stressing and permits a faster test cycle. Discharge current and time are measured and calculated. The characteristics of electrostatic attenuation of domestic semiconductor devices are investigated to evaluate the ESD phenomena in the semiconductors. Also, the field charging mechanism, the device thresholds and failure modes are investigated and analyzed. The damaged devices obtained in the simulator are analyzed and evaluated by SEM. The results obtained in this paper can be used to prevent semiconductor devices form ESD hazards and be a foundation of research area and industry relevant to ESD phenomena.

• Journal of the Korean Institute of Gas
• /
• v.5 no.4 s.16
• /
• pp.62-69
• /
• 2001

Gas safety devices are very effective to prevent catastrophic gas accident in domestic. The safety devices are included in domestic gas equipment such as extinguishing safety device and adapted at pipeline such as fuse cock, shut off device with gas alarm and so forth. In spite of using those safety devices, a few hundreds of gas accident was happened annually in residential house. In this study, we analysed systematically the domestic accidents which was happened in five years using fault tree analysis(FTA) method and analysed the effectiveness of individual safety device. And also, it was suggested that the rate of accident was decreased quantitatively by increasing safety device which is adapted in domestic. By analysis of 769 gas accidents in domestic, the order of effectiveness of safety device to prevent domestic gas accident was the multi-functional gas-safe-meter(micom-meter), fuse cock, gas leak alarm and CO alarm. If the above four kind of safety device are adapted to every house, about $59\%$ of accident will be reduced and the most of catastrophic gas accident will be Prevented in domestic.

• Journal of Microbiology and Biotechnology
• /
• v.27 no.12
• /
• pp.2141-2150
• /
• 2017

This study was conducted to develop a screening method using Colilert-18 and a device for the detection of E. coli from agri-food production environments and fresh vegetables. The specificity and sensitivity of Colilert-18 by temperature ($37^{\circ}C$ and $44^{\circ}C$) were evaluated with 38 E. coli and 78 non-E. coli strains. The false-positive rate was 3.8% (3/78) and 0% (0/78) at $37^{\circ}C$ and $44^{\circ}C$, respectively. The detection limit of E. coli at $37^{\circ}C$ at <1.0 log CFU/250 ml was lower than that at $44^{\circ}C$. The efficiency of the developed device, which comprised an incubator equipped with a UV lamp to detect E. coli in the field, was evaluated by measuring the temperature and UV lamp brightness. The difference between the set temperature and actual temperature of the developed device was about $1.0^{\circ}C$. When applying the developed method and device to various samples, including utensils, gloves, irrigation water, seeds, and vegetables, there were no differences in detection rates of E. coli compared with the Korean Food Code method. For sanitary disposal of culture samples after experiments, the sterilization effect of sodium dichloroisocyanurate (NaDCC) tablets was assessed for use as a substitute for an autoclave. The addition of one tablet of NaDCC per 50 ml was sufficient to kill E. coli cultured in Colilert-18. These results show that the developed protocol and device can efficiently detect E. coli from agri-food production environments and vegetables.