• Title/Summary/Keyword: functional safety

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Efficient Approaches of Functional Safety for Medical Equipment using Essential Performance Analysis (필수성능 분석을 통한 효율적인 의료기기 기능안전 접근 방안)

  • Kim, Gi-Young;Yoo, Ki-Hoon;Park, Ho-Joon;Jang, Joong-Soon
    • Journal of Applied Reliability
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    • v.15 no.1
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    • pp.27-32
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    • 2015
  • Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.

Analysis of quercetin in extract of Hovenia dulcis Thunb (헛개나무과병추출물 중 퀘르세틴 분석)

  • Hu, SooJung;Oh, Jae-Myoung;Oh, Hyun-Suk;Moon, Myung-Hee;Bae, Yun-Young;Lee, Sung-Hye;Kim, Ji-An;Koo, Yong-Eui
    • Analytical Science and Technology
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    • v.29 no.6
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    • pp.255-260
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    • 2016
  • Based on the Korean Health Functional Food Act, health functional foods are dietary supplements containing nutrients or other substances that have nutritional or physiological effects. Since generic health functional food items have been expanded, this project was performed to develop a standardized analytical method of examining such sale items. The method exhibited high linearity in the quercetin calibration curve ($R^2$ > 0.999) over concentrations of $0-40{\mu}g/mL$. The limits of detection and quantitation for quercetin were $0.12{\mu}g/mL$ and $0.36{\mu}g/mL$, respectively, while quercetin recovery was 97.1-105.4 % with standard deviations of 1.15-3.11 %. To verify the accuracy of the analytical methods, the labeled amounts of purchased health functional foods were monitored. The recovery rate for multiple quercetin concentrations ranged from 82.5-105.1 % of the labeled amounts. Thus, the new method was suitable for all cases.

Algorithms for Causality Evaluation of Adverse Events from Health/Functional Foods (건강기능식품 부작용 원인분석을 위한 알고리즘)

  • Lee, Kyung-Jin;Park, Kyoung-Sik;Kim, Jeong-Hun;Lee, Young-Joo;Yoon, Tae-Hyung;No, Ki-Mi;Park, Mi-Sun;Leem, Dong-Gil;Yoon, Chang-Yong;Jeong, Ja-Young
    • Journal of Food Hygiene and Safety
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    • v.26 no.4
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    • pp.302-307
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    • 2011
  • One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

Development of a Multiplex Polymerase Chain Reaction Method for Simultaneous Detection of Genetically Modified Soy and Maize

  • Park, Kyoung-Sik;Kim, Mi-Gyeong;Leem, Dong-Gil;Yoon, Tae-Hyung;No, Ki-Mi;Hong, Jin;Kwon, Eun-Mi;Moon, Ae-Rie;Jeong, Ja-Young
    • Journal of Food Hygiene and Safety
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    • v.25 no.3
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    • pp.278-280
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    • 2010
  • This study was aimed to develop a novel qualitative multiplex polymerase chain reaction (PCR) for simultaneous detection of genetically modified (GM) soy and maize within a single reaction. The specific primers designed to detect four respective GM events (A2704-12, MON88017, Bt11, and MON863) were included in the tetraplex PCR system. Each of PCR products for four GM events could be distinguished by agarose gel based on their different lengths. The specificity and reproducibility of this multiplex PCR were evaluated. This multiplex PCR consistently amplified only a fragment corresponding to a specific inserted gene in each of the four GM events and also amplified all four of the PCR products in the simulated GM mixture. These results indicate that this multiplex PCR method could be an effective qualitative detection method for screening GM soy and maize in a single reaction.

Development of functional food products with natural materials derived from marine resources (건강기능성 수산식품소재의 개발)

  • Ryu, BoMi;Jeon, You-Jin
    • Food Science and Industry
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    • v.51 no.2
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    • pp.157-164
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    • 2018
  • Recently demand for safer and healthier food has augmented with advancements in health conditions. Food ingredients with yet to be known safety and functionality, are being investigated for their safety or detrimental effects. The Ministry of Food and Drug Safety has introduced "health functional food" by the "Health Functional Food Act" to evaluate bio-functional and safety properties of raw materials using standard methods including in-vitro and in-vivo testing before human consumption. Despite recent growth in net worth of domestic functional food market, most of the raw materials are not from local Korean industries with own research and development, and mostly terrestrial not marine resources. Geographically, Korea has access to diverse marine bio-resources that need to be managed and utilized sustainably. Recently, diverse novel physiologically active substances have been reported from marine organisms. Hence, the development of functional foods from marine bio-resources is considered as an inevitably important task.

On a Hazard Identification Method Based on Functional Safety and SysML (SysML을 활용한 기능안전 기반의 위험원 분석 방법)

  • Jung, Ho Jeon;Lee, Jae-Chon
    • Journal of the Korea Safety Management & Science
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    • v.16 no.1
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    • pp.79-88
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    • 2014
  • The rapid growth of complexity and scale can be witnessed in the design and development of modern systems. As such, the severity of damages in the occasional accidents has attracted great deal of attention lately. Although a variety of methods have so far been studied to overcome or reduce the disastrous results of hazards, the issues seem still persistent and even complicated due to the situation mentioned above. The concept of functional safety has been regarded as one approach to handling the matters by shifting up to the functions level from the consideration of each physical component itself. The outcomes of those efforts would be the international standards on functional safety such as IEC 61508 and its relatives including IEC 62278, EN 50128, ISO26262, and so on. In this paper, a method of how hazards can be analyzed to be coped with those standards has been studied. In the method proposed, the systems modeling language (SysML) is playing a key role to model and analyze the hazards from the viewpoint of functional safety. The approach taken has been applied in the analysis of the hazards in railroad systems. In spite of focusing on the individual components hazards, the method based on functional safety has analyzed them collectively with the added effect of identifying the cause originated from the interface between the functions.

Research on Application of Functional Safety for Developing Combat Hybrid Electric Vehicles (하이브리드 전투차량의 기능안전성 적용 연구)

  • Chang, Kyogun;Lee, Yoon Bok
    • Journal of the Korea Institute of Military Science and Technology
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    • v.15 no.5
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    • pp.543-549
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    • 2012
  • Hybrid electric propulsion systems are expected as future primary combat platforms because the systems can supply enough electric power, easily locate components inside vehicles, and maneuver without undesired noise. However, increasing electric/electronic/software usage causes abnormal failure patterns which have not been noticeable in conventional automotive. Recently, the functional safety standard for road vehicles were enacted and vehicle manufacturers request their components which satisfy standardized quality. This research analyzes functional safety standards(IEC 61508 and ISO 26262) and compares the standards for road vehicles with military standards of system safety. Strategies to apply functional safety in the combat hybrid electric vehicle are scrutinized.

Case Study on AUTOSAR Software Functional Safety Mechanism Design: Shift-by-Wire System (AUTOSAR 소프트웨어 기능안전 메커니즘 설계 사례연구: Shift-by-Wire 시스템)

  • Kum, Daehyun;Kwon, Soohyeon;Lee, Jaeseong;Lee, Seonghun
    • IEMEK Journal of Embedded Systems and Applications
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    • v.16 no.6
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    • pp.267-276
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    • 2021
  • The automotive industry and academic research have been continuously conducting research on standardization such as AUTOSAR (AUTomotive Open System ARchitecture) and ISO26262 to solve problems such as safety and efficiency caused by the complexity of electric/electronic architecture of automotive. AUTOSAR is an automotive standard software platform that has a layered structure independent of MCU (Micro Controller Unit) hardware, and improves product reliability through software modularity and reusability. And, ISO26262, an international standard for automotive functional safety and suggests a method to minimize errors in automotive ECU (Electronic Control Unit)s by defining the development process and results for the entire life cycle of automotive electrical/electronic systems. These design methods are variously applied in representative automotive safety-critical systems. However, since the functional and safety requirements are different according to the characteristics of the safety-critical system, it is essential to research the AUTOSAR functional safety design method specialized for each application domain. In this paper, a software functional safety mechanism design method using AUTOSAR is proposed, and a new failure management framework is proposed to ensure the high reliability of the product. The AUTOSAR functional safety mechanism consists of memory partitioning protection, timing monitoring protection, and end-to-end protection. The fault management framework is composed of several safety SWCs to maintain the minimum function and performance even if a fault occurs during the operation of a safety-critical system. Finally, the proposed method is applied to the Shift-by-Wire system design to prove the validity of the proposed method.

Standardization for Analysis Method of Total Polyphenol in Complex of Picao Preto (피카오프레토 등 복합물 중 총 폴리페놀 분석법 표준화)

  • Hu, Soojung;Kim, Ji-An;Moon, Myung-Hee;Lee, Sung-Hye;Yoon, Hae-Seong;Hong, Jin-Hwan
    • Journal of Food Hygiene and Safety
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    • v.33 no.1
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    • pp.44-49
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    • 2018
  • As generic health functional food items have been expanded, this research project has been conducted to prepare a scientific and systematic standardized analytical method of relevant food item and examine the suitability of the method for health/functional foods on sale. Total polyphenol was necessary for development and verification of standardized analytical method. The method exhibited high linearity in the tannic acid calibration curve ($r^2$ > 0.999) over concentrations of $5-50{\mu}g/mL$. The limits of detection and quantitation for tannic acid were $5{\mu}g/mL$ and $15{\mu}g/mL$, respectively, while tannic acid recovery was 102.3-112.4% with standard deviations of 0.8-3.2%. To verify the accuracy of the analytical method, the labeled amounts of purchased health functional foods were monitored. The recovery for tannic acid was 105.6% of the labeled amounts. Thus, the new method was suitable for all cases.