• 한국신뢰성학회지:신뢰성응용연구
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• 제15권1호
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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.

• Journal of Nutrition and Health
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• 제50권2호
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• pp.202-202
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• 2017

• 분석과학
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• 제29권6호
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• pp.255-260
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• 2016

"건강기능식품에 관한 법률"에 따라 건강기능식품이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조한 식품을 말한다. 또한, 건강기능식품은 고시화한 원료와 영업자가 개별적으로 신청한 개별인정형 원료로 나누어진다. 그 중 개별인정형 원료의 시험법은 고시화를 위해 표준화가 필요하며 2가지 이상의 원료가 복합적으로 혼합되어 제조될 경우 제품에 대한 적용성 검토가 요구된다. 개별인 정형 원료 중 헛개나무과병추출물의 지표성분인 퀘르세틴을 대상으로 전처리방법을 표준화하였으며, 표준화한 퀘르세틴 시험법의 밸리데이션을 수행한 결과 회수율은 97.1~105.4%, 표준편차는 1.15~3.11%였다. 검량선의 직선성은 결정계수($R^2$)가 0.999 이상을 나타냈고 검출한계는 $0.12{\mu}g/mL$, 정량한계는 $0.36{\mu}g/mL$를 나타냈다. 표준화한 퀘르세틴 시험법의 적용성 검토를 위해 헛개나무과병추출물의 유통제품을 수거하여 분석한 결과, 퀘르세틴 표시 함량 대비 82.5~105.1%로 적합하였다.

• 한국식품위생안전성학회지
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• 제26권4호
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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.

• 한국식품위생안전성학회지
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• 제25권3호
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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.

• 식품과학과 산업
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• 제51권2호
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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.

• 대한안전경영과학회지
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• 제16권1호
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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.

• 한국군사과학기술학회지
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• 제15권5호
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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.

• 대한임베디드공학회논문지
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• 제16권6호
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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.

• 한국식품위생안전성학회지
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• 제33권1호
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• pp.44-49
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• 2018

피카오프레토 등 복합물의 개별인정 시험법인 총 폴리페놀 시험법에서 Folin-phenol 시약 선정, 발색시약인 35% 탄산나트륨의 반응시간 및 온도, 시료량 등을 비교 실험하여 총 폴리페놀에 대한 표준화된 시험법을 확립하였다. 총 폴리페놀의 표준화된 시험법의 밸리데이션을 수행한 결과 회수율은 102.3~112.4%, 정밀도의 표준편차는 0.81~3.18%였으며 검량선의 직선성은 결정계수($r^2$)가 0.999이상을 나타냈고 검출한계는 $5{\mu}g/mL$, 정량한계는 $15{\mu}g/mL$이었다. 유통제품에 대해 표준화된 총 폴리페놀 시험법의 적용성 검토를 위해 1건의 검체를 수거하여 분석한 결과, 총 폴리페놀 표시 함량 대비 105.6%로 적합하였다.