• 제목/요약/키워드: Standard Labeling

검색결과 105건 처리시간 0.028초

의료기기의 결함으로 인한 손해배상책임과 미국 연방법 우선 적용 이론에 관하여 (The Liability for Unsafe Medical Product and The Preemption Clause of Medical Device Act)

  • 김장한
    • 의료법학
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    • 제15권2호
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    • pp.63-89
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    • 2014
  • In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

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에지 및 컬러 양자화를 이용한 모바일 폰 카메라 기반장면 텍스트 검출 (Mobile Phone Camera Based Scene Text Detection Using Edge and Color Quantization)

  • 박종천;이근왕
    • 한국산학기술학회논문지
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    • 제11권3호
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    • pp.847-852
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    • 2010
  • 자연 영상 내에 포함된 텍스트는 영상의 다양하고 중요한 특징을 갖는다. 그러므로 텍스트를 검출하고 추출하여 인식하는 것이 중요한 연구대상으로 연구되고 있다. 최근 모바일 폰 카메라를 기반으로 다양한 분야에서 많은 응용 기술이 연구 개발되고 있다. 본 논문은 에지 및 연결요소를 이용한 장면 텍스트 검출 방법을 제안한다. 그레이스케일 영상으로부터 에지 성분 검출과 지역적 표준편차를 이용하여 텍스트 영역의 경계선을 검출하고, RGB 컬러공간의 유클리디안 거리를 기준으로 연결요소를 검출한다. 검출된 에지 및 연결요소를 레이블링하고 각각 영역의 외곽사각형을 구한다. 텍스트의 휴리스틱 이용하여 후보 텍스트를 추출한다. 후보 텍스트 영역을 병합하여 하나의 후보 텍스트 영역을 생성하고, 후보 텍스트의 지역적 인접성과 구조적 유사성으로 후보 텍스트를 검증함으로서 최종적인 텍스트 영역을 검출하였다. 실험결과 에지 및 컬러 연결요소 특징을 상호 보완함으로서 텍스트 영역의 검출률을 향상시켰다.

Efficient hardware implementation and analysis of true random-number generator based on beta source

  • Park, Seongmo;Choi, Byoung Gun;Kang, Taewook;Park, Kyunghwan;Kwon, Youngsu;Kim, Jongbum
    • ETRI Journal
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    • 제42권4호
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    • pp.518-526
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    • 2020
  • This paper presents an efficient hardware random-number generator based on a beta source. The proposed generator counts the values of "0" and "1" and provides a method to distinguish between pseudo-random and true random numbers by comparing them using simple cumulative operations. The random-number generator produces labeled data indicating whether the count value is a pseudo- or true random number according to its bit value based on the generated labeling data. The proposed method is verified using a system based on Verilog RTL coding and LabVIEW for hardware implementation. The generated random numbers were tested according to the NIST SP 800-22 and SP 800-90B standards, and they satisfied the test items specified in the standard. Furthermore, the hardware is efficient and can be used for security, artificial intelligence, and Internet of Things applications in real time.

Post-harvest Technology for High Quality Rice in Japan

  • Ohtsubo, Kenichi
    • 한국식품저장유통학회:학술대회논문집
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    • 한국식품저장유통학회 2003년도 제23차 추계총회 및 국제학술심포지움
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    • pp.26-32
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    • 2003
  • Rice is one of the most important cereals in the world. Japanese people use about 9 million tons of rice per you. We use rice for cooked rice as staple foods and for processing, such as rice wine (sake), rice crackers and miso fermentation, etc. Palatability, eating quality, of rice is evaluated by the sensory test and various kinds of physicochemical measurements. Japanese National Food Agency started the storage of 1.5 million tones of rice in 1996. We carried out the storage test using high quality rices since 1995 until 1996. As indices for the quality deteriorations of rice grains during the storage, germination ratio, enzyme activities, fat acidity, physical properties of cooked rice were clarified to be useful. We applied colorimetric method for the measurements of fat acidities in the place of titration method. Processing suitabilities of rice differ depending on the products. Low amylose rice is more suitable for soft rice crackers and high amylose rice is preferred more for rice noodle. Pre-cooked rice products, such as frozen cooked rice, retort-pouched rice and aseptic rice, are increasing recently in Japan. In addition to above-mentioned physico-chemical tests, NIR spectroscopy,“Midometer”and“Taste sensor”are novel and useful to evaluate eating quality and processing suitabolities. Recently, rice wholesalers and retailers have been obligated to display the name of cultivar, location of cultivation and the year of production of rice grains which they sell by the Japanese Agricultural Standard Law (JAS). In order to detect the dishonest labeling of rice cultivars, we developed new cultivar identification method based on DNA polymorphism.

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Disparity between MR Imaging and Histochemical Grading in Human Intervertebral Disc Degeneration

  • Lee, June-Ho;Chung, Chun-Kee;Kim, Hyun-Jib
    • Journal of Korean Neurosurgical Society
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    • 제39권6호
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    • pp.432-437
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    • 2006
  • Objective : In order to establish the index of degeneration, the authors performed a histochemical study with Safranin-O staining and investigated the occurrence of apoptosis in the human intervertebral disc. Methods : Eighteen intervertebral disc specimens surgically extracted from the patients and two additional specimens from the autopsied cases were stained with Safranin-O for proteoglycan according to a standard protocol. Terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate- biotin nick end labeling[TUNEL] was used to detect the fragmented DNA known to be associated with apoptotic cell death and classification scheme was formulated for categorization of the degree of Safranin-O staining [normal, moderate reduction, faint] by modification of Makin's histological-histochemical grading. The Kruskal-Wallis H test and Chi-square test were used for statistical analysis. Results : The statistical results showed a significant difference in the mean age between "normal" Safranin-O staining group and the others [19.3 versus 55, 43.4, p=0021]. However, there was no statistically significant correlation between Safranin-O staining and MR grading of disc degeneration. Only six of eighteen surgical specimens and none in autopsies showed positive apoptotic cells in TUNEL staining. Conclusion : The determination of the degree of degeneration in surgically obtained disc tissue per se by histochemical staining or by the degree of apoptosis that corresponds to its morphologic change was not feasible.

Development of Dataset Items for Commercial Space Design Applying AI

  • Jung Hwa SEO;Segeun CHUN;Ki-Pyeong, KIM
    • 한국인공지능학회지
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    • 제11권1호
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    • pp.25-29
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    • 2023
  • In this paper, the purpose is to create a standard of AI training dataset type for commercial space design. As the market size of the field of space design continues to increase and the time spent increases indoors after COVID-19, interest in space is expanding throughout society. In addition, more and more consumers are getting used to the digital environment. Therefore, If you identify trends and preemptively propose the atmosphere and specifications that customers require quickly and easily, you can increase customer trust and conduct effective sales. As for the data set type, commercial districts were divided into a total of 8 categories, and images that could be processed were derived by refining 4,009,30MB JPG format images collected through web crawling. Then, by performing bounding and labeling operations, we developed a 'Dataset for AI Training' of 3,356 commercial space image data in CSV format with a size of 2.08MB. Through this study, elements of spatial images such as place type, space classification, and furniture can be extracted and used when developing AI algorithms, and it is expected that images requested by clients can be easily and quickly collected through spatial image input information.

Structural SVM을 이용한 백과사전 문서 내 생략 문장성분 복원 (Restoring Omitted Sentence Constituents in Encyclopedia Documents Using Structural SVM)

  • 황민국;김영태;나동열;임수종;김현기
    • 지능정보연구
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    • 제21권2호
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    • pp.131-150
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    • 2015
  • 영어와 달리 한국어나 일본어 문장의 경우 용언의 필수격을 채우는 명사구가 생략되는 무형대용어 현상이 빈번하다. 특히 백과사전이나 위키피디아의 문서에서 표제어로 채울 수 있는 격의 경우 그 격이 문장에서 더 쉽게 생략된다. 정보검색, 질의응답 시스템 등 주요 지능형 응용시스템들은 백과사전류의 문서에서 주요한 정보를 추출하여 수집하여야 한다. 그러나 이러한 명사구 생략 현상으로 인해 양질의 정보추출이 어렵다. 본 논문에서는 백과사전 종류 문서에서 생략된 명사구 즉 무형대용어를 복원하는 시스템의 개발을 다루었다. 우리 시스템이 다루는 문제는 자연어처리의 무형대용어 해결 문제와 거의 유사하나, 우리 문제의 경우 문서의 일부가 아닌 표제어도 복원에 이용할 수 있다는 점이 다르다. 무형대용어 복원을 위해서는 먼저 무형대용어의 탐지 즉 문서 내에서 명사구 생략이 일어난 곳을 찾는 작업을 수행한다. 그 다음 무형대용어의 선행어 탐색 즉 무형대용어의 복원에 사용될 명사구를 문서 내에서 찾는 작업을 수행한다. 문서 내에서 선행어를 발견하지 못하면 표제어를 이용한 복원을 시도해 본다. 우리 방법의 특징은 복원에 사용된 문장성분을 찾기 위해 Structural SVM을 사용하는 것이다. 문서 내에서 생략이 일어난 위치보다 앞에 나온 명사구들에 대해 Structural SVM에 의한 시퀀스 레이블링(sequence labeling) 작업을 시행하여 복원에 이용 가능한 명사구인 선행어를 찾아내어 이를 이용하여 복원 작업을 수행한다. 우리 시스템의 성능은 F1 = 68.58로 측정되었으며 이는 의미정보의 이용 없이 달성한 점을 감안하면 높은 수준으로 평가된다.

GC-FID를 이용한 조제유류 중 지방산 분석법 개선 연구 (Improvement of Analysis Methods for Fatty Acids in Infant Formula by Gas Chromatography Flame-Ionization Detector)

  • 황금희;최원희;허수정;이혜영;황경미
    • 한국식품위생안전성학회지
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    • 제36권1호
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    • pp.34-41
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    • 2021
  • 본 연구는 조제유류 중 지방산에 대해 최신 분석법을 마련하고자 수행하였다. 조제유류 중 지방산 함량 분석을 위해 GC를 이용한 분석법을 확립하고 시중에 유통 중인 제품을 대상으로 적용성을 검토하였다. 분석법 검증은 특이성, 직선성, 검출한계 및 정량한계, 정확성, 정밀성에 대해 수행되었다. Linoleic acid 및 α-linolenic acid의 0.1-5 mg/mL 농도범위에서 R2=0.999 이상의 우수한 직선성을 확인할 수 있었다. Linoleic acid 및 α-linolenic acid의 LOD는 각각 0.06 mg/mL, 0.01 mg/mL, LOQ는 각각 0.16 mg/mL, 0.03 mg/mL였다. 표준인증물질 분석을 통해 정확성을 검토하였으며, linoleic acid 및 α-linolenic acid의 회수율은 각각 100.8%와 101.1%로 확인하였다. 정밀성을 검토한 결과 시료 채취량에 따른 반복성은 linoleic acid 1.4-2.9%, α-linolenic acid 1.1-2.7%이었고, 실험실간 재현성은 각각 2.8%, 1.5%임을 확인하였다. 본 연구에서 확립된 분석법을 적용하여 국내 유통 중인 조제유류 및 조제식 제품 12건에 대해 적용성 검토를 실시한 결과 전체 시료에서 분석이 용이하였으며, 모두 기준·규격에 적합함을 확인하였다. 본 결과로부터 확립된 GC를 이용한 분석법은 조제유류 중 지방산 함량을 확인하기에 적합함을 확인하였으며 국내 식품 영양성분의 관리 기반을 강화하는데 기여할 것으로 사료된다.

영양표시 양식에 따른 소비자의 이해도와 선호도 조사연구 (A Study of the Comprehension and Preference of Consumers to Four Different Formats of Nutrition Label)

  • 장순옥
    • Journal of Nutrition and Health
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    • 제30권6호
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    • pp.679-689
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    • 1997
  • Nutrition label (NL) on the package of processed food provides consumers with a reliable and consistent source of information . It has been considered as a useful aid for food selection and a potent educational tool for nutrition in daily life. Since current nutrition labeling regulation in Korea does not define a format for presenting nutrition information a wide variety of NL format exists in the markers created by individual manufacturers. Development of standard NL format and its registration remain to be the work for the professionals and government officials. However the acceptance and evaluation of NL by the consumers is a very important and necessary process in the development of NL formats. In this study four different formats A, B, C, D were formulated based on currently circulating labels and new U.S.NL. Subjects used for evaluation of these formats were middle -aged highly educated housewives, who and the potential users of NL. Major parameters observed through the questionnare were their nutritional knowledge of RDA, ability of IC(Information Comparison) and CA (Comprehension and Application of informed nutrient contents), as well as their preference to the different formats. The results are summarized as follows. 1) Of the 178 subjects , 89.9% of the middleaged housewives were college graduates. Their nutrition knowledge of RDA were relatively satisfactory showing over 80% correlation on the basic concepts and unit while for numerical value less than 50% correct answer. 2) IC test scores were significantly different among the formats showing the highest values for format A and B which are presented as absolute value and % RDA, respectively. Format C presented as serving size(number of products) showed the lowest score. CA scores were also significantly different, though the increased load of information did not facilitate to increase the consumers comprehension. 3) RDA knowledge test scores and the scores of IA and CA were correlated in format A and D but not in format B and C suggesting % RDA presentation would be more acceptable to the less educated group. 4) For the preference in the aspects of easiness and time-saving format A was the best one then format D supporting the result of IC and CA test. The results of the present study indicate the most useful and preferred format is the simplest format presented as absolute value without RDA, . The secondly preferred format is the new NL format of the US with much information .

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폭력성 비디오게임에 대한 미국 연방순회항소법원판결이 한국게임법제도에 주는 시사점 : Video Software Dealers Association v. Arnold Schwarzenegger(2009) (Video Software Dealers Association v. Arnold Schwarzenegger(2009) of the United States Court of Appeals, Ninth Circuit and its Implication to the Korean Game Law)

  • 박민;황승흠
    • 한국게임학회 논문지
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    • 제10권1호
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    • pp.65-78
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    • 2010
  • 이 논문은 2009년 2월 20일 미국의 제9 연방순회항소법원에서 내려진 Video Software Dealers Association v. Arnold Schwarzenegger 사건에 대한 판결의 의미와 한국게임법제도에의 시사점을 검토한 것이다. 이 사건에서 제9 연방순회항소법원은 폭력성 비디오게임을 18세 미만의 미성년자에게 판매하거나 대여하는 것을 금지하는 캘리포니아 주법(州法)이 미국 연방헌법에 명시된 미성년자 (minor)의 권리를 침해한다는 판결을 내렸다. 이에 비해서 한국의 헌법재판소는 청소년보호를 위한 청소년유해매체물 제도와 사전등급분류 제도에 대해서는 합헌이라는 결정을 하였다. 헌법재판소는 미국의 제9 연방항소법원의 판결과 같이 음란과 폭력성을 구분하여 접근하고 있고, 폭력성 개념이 대해서 간접적으로 위헌적이라는 결정을 한 바 있다. 미국법원의 덜 제한적인 수단의 선택이라는 법리와 헌법재판소의 최소침해성 원칙에서 본다면 청소년유해매체물 제도와 사전등급분류 제도의 중첩 적용은 문제될 수 있으며, 이 중에서 더 강한 규제가 위헌이 될 소지가 있다.