• Title/Summary/Keyword: safety and performance evaluation

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Research of Developing of Standards for Electronic Thermometers (전자식체온계 기준규격 개발 연구)

  • Kim, E.J.;Lee, M.J.;Lee, B.Y.;Park, K.G.;Kim, D.S.;Lee, I.S.;Park, H.D.;Jeong, H.K.
    • Journal of Biomedical Engineering Research
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    • v.31 no.2
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    • pp.123-128
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    • 2010
  • The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

A study on Evaluation Methods for Safety and Performance of Electrical Stimulations for Home Use (개인용전기자극기 성능 및 안전성 평가 방법 연구)

  • Kim, San;Jang, Moo-Young;Hwang, Yoon Su;Lee, Ki-Hun;Hur, Chan-Hoi;Hong, Choongman
    • Journal of the Institute of Electronics and Information Engineers
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    • v.50 no.3
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    • pp.187-202
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    • 2013
  • The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.

Development of Standards of Tattoo Machine for Safety and Performance Evaluation (의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구)

  • Kim, Y.G.;Cho, S.K.;Lee, T.W.;Yeo, C.M.;Jung, B.J.;Kwon, Y.M.;Cha, J.H.;Hur, C.H.;Park, K.J.;Kim, D.S.;Kim, H.S.
    • Journal of Biomedical Engineering Research
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    • v.32 no.2
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    • pp.151-157
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    • 2011
  • Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

Evaluation of Performance and Service Life of Low Pressure LPG Regulators for Home Use

  • Kim Young-Gyu;Cho Seok-Beom;Kim Pil-Jong;Kwon Boo-Kil
    • Journal of Mechanical Science and Technology
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    • v.20 no.3
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    • pp.329-334
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    • 2006
  • This paper presents the evaluation of LPG (Liquefied petroleum gas) regulators for home use. For the evaluation, several properties of the regulators were experimentally analyzed, such as the operation of safety device, the adjusting and lock-up pressure, the adjusting spring and the diaphragm, with respect to the used time of the regulators. Experimental results showed that the initial operation performances of regulators were degraded with increase of the service time and also showed that the degradation of the performance and material property could become serious after about six-year-use of the regulators.

A study on performance-based evaluation system for NATM tunnels in use: development of evaluation model and validation (공용중인 NATM 터널의 성능중심 평가체계 연구: 평가모형 개발 및 검증)

  • Moon, Joon-Shik;Kim, Hong-Kyoon;An, Jai-Wook;Lee, Jong-Gun
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.22 no.1
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    • pp.107-120
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    • 2020
  • In a performance-based evaluation of structures in use, the current performance is assessed by summing up the weighting of the evaluation indices for each performance. In this study, to suggest a performance-based evaluation technique for NATM tunnels in use, the performance evaluation indices were derived by examining the characteristics and similarities of each index developed from previous study. The weighting of the evaluation indices was derived by calculating the relative importance of each evaluation indices from the AHP analysis. In order to develop a quantitative evaluation model, grading criteria for each performance index was derived through literature review, and performance evaluation tables for road and railway tunnels were presented. In order to verify the significance of the proposed performance evaluation model, the correlation analysis was performed between each evaluation index and the final evaluation result. In the correlation analysis, the survey data measured through precision safety diagnosis in the tunnel in use was applied. It may be said that the proposed evaluation indices, weighting, criteria and evaluation models for tunnels in use can be applied to the performance-based maintenance system of tunnels.

A Study on the Development of Navigational Safety Evaluation System in Rough Sea (황천시의 항해안전 평가시스템 개발에 관한 연구)

  • 김순갑;이충노
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 1991.06a
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    • pp.12-20
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    • 1991
  • It is of great importance for any vessel under way especially in rough sea to be maneuvered safely with proper seakeeping performance. In this paper the author aims to develope a navigational safety evaluation system in rough sea by analysis and the theory of evaluating the seakeeping performance The author suggests a computer model of navigational safety evaluation system and examined the validity of the model by computer simulation.

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Development and Validation of Safety Performance Evaluation Scenarios of Autonomous Vehicle (자율주행 안전성 평가 시나리오 개발 및 검증)

  • Chae, Heungseok;Jeong, Yonghwan;Lee, Myungsu;Shin, Jaekon;Yi, Kyongsu
    • Journal of Auto-vehicle Safety Association
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    • v.9 no.1
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    • pp.6-12
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    • 2017
  • Regulation for the testing and operation of automated vehicles on public roadways has been recently developed all over the world. For example, the licensing standards and the evaluation technology for automated vehicles have been proposed in California, Nevada and EU. But specific safety evaluation scenarios for automated vehicles have not been proposed yet. This paper presents safety evaluation scenarios for extraordinary service permission of automated vehicles on highways. A total of seven scenarios are selected in consideration of safety priority and real traffic situation. Six scenarios are relevant with lane keeping and one scenario is relevant with lane change. All scenarios are developed based on existing ADAS evaluation scenarios and repeated simulation of automated vehicle algorithm. Safety evaluation factors as well as scenarios are developed. The safety factors are based on existing ADAS ISO requirements, ADAS safety factors and current traffic regulations. For the scenarios, a hunter vehicle is needed in addition to automated vehicle evaluated. The hunter vehicle performs multiple roles like preceding vehicle, cut-in vehicle and so on. The hunter vehicle is also automated vehicle equipped with high performance GPS, radar and Lidar. All the scenarios can be implemented by driving a lap on a KATRI ITS test track. These scenarios and safety evaluation factors are investigated via both a computer simulation and an experimental vehicle test on the test track. The experimental vehicle test was conducted with two automated vehicles, which are the evaluated vehicle and the hunter vehicle.

A Study on the Analysis of Safety Standard and Evaluation of Safety Performance for the 5 Nm3 /hr Class Alkaline Water Electrolysis System (5 Nm3 /hr급 알카라인 수전해 시스템 안전기준 분석 및 안전성능 평가에 관한 연구)

  • Kim, Ji-Hye;Lee, Eun-Kyung;Kim, Min-Woo;Oh, Gun-Woo;Lee, Jung-Woon;Kim, Woo-Seop
    • Journal of the Korean Institute of Gas
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    • v.22 no.6
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    • pp.65-75
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    • 2018
  • The wind energy produced at night is being discarded because of the excess power generated at night compared to daytime. To solve this problem, In this study, we analyzed the evaluation contents for evaluation of domestic and overseas water electrolysis systems and drew contents for safety performance contents test of the water electrolysis system based on the evaluation contents. The test contents produced the efficiency measurement test, the hydrogen generated pressure test, and the hydrogen purity test. And the safety performance evaluation of the alkaline water electrolysis system of $5Nm^3/hr$ was performed based on the results. As a result, the hydrogen generation was calculated as $5.10Nm^3/hr$ and the stack efficiency was $4.97kWh/Nm^3$. The purity of the hydrogen generated was 99.993% and it was confirmed that it produced high purity hydrogen. I think will help us assess and build safety performance of water electrolysis systems in the future.

Study of Seismic Resistance Performance Evaluation Method for Existing Mid-Low Story RC Structure Buildings by Applying Fuzzy Theory (퍼지이론을 적용한 기존 중저층 철근콘크리트 건축물의 내진성능평가기법 연구)

  • Kim, Dong-Hee;Kim, Hyun-Su
    • Journal of Korean Association for Spatial Structures
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    • v.17 no.2
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    • pp.53-62
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    • 2017
  • This study aims to establish a seismic resistance performance evaluation method that makes sure to secure the seismic resistance performance of the existing mid-low story reinforced concrete structures. This study focuses on the development of the seismic resistance performance evaluation method for the overall seismic resistance performance evaluation on the buildings by applying fuzzy theory. This seismic resistance performance evaluation method considers the mutual relations among the type of force, the type of member, the type of story, and the states of deterioration of the buildings. The total seismic resistance performance index from this method was calculated by the intensity weight of each evaluation item, fuzzy measure, fuzzy integration. Moreover, the evaluation methodology was established in this study to identify the performance level of the Immediate Occupancy, Life Safe, Collapse Prevention by applying the fuzzy theory.