• 제목/요약/키워드: Approval standard

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융합 신기술을 채택한 방송통신기기의 대안적 적합성 평가체계 연구: 기술기준 부재의 경우를 중심으로 (Introduction of Alternative Conformity Assessment System for New Radio, Telecommunication and Broadcasting Equipment Without Technical Requirement)

  • 이용규;한주연
    • 한국통신학회논문지
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    • 제34권2B호
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    • pp.203-211
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    • 2009
  • 방송 통신융합 현상이 나타남에 따라 인증기준이 제정되지 않은 상황에서 제조자가 제품에 대한 출시 승인을 요청하는 상황이 빈번하게 발생하고 있다. 그럼에도 불구하고 이러한 상황에 대처할 수 있는 행정처분절차는 부재한 상황이다. 이러한 관점에서 본 연구는 잠정인종제도(잠정행정처분제도), SDoC와 기술기준의 민간화제도 등을 해결책으로 제시하였다. SDoC와 기술기준 민간화제도의 도입은 원천적으로 기술기준이 존재하지 않는 제품의 등장을 최소화시킬 수 있으며, 잠정인증제도는 기술기준이 부재한 경우에 행정적 해결책을 제시할 수 있을 것이다.

선박식별 및 추적장치의 국제동향과 전자항해전략에 관한 연구 (International Trends on Vessel Identification and Tracking and E- Navigation Strategy)

  • 정중식;남택근;김철승;박성현;임정빈;안영섭
    • 한국항해항만학회:학술대회논문집
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    • 한국항해항만학회 2006년도 춘계학술대회 및 창립 30주년 심포지엄(논문집)
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    • pp.105-111
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    • 2006
  • IMO COMSAR 10차 회의의 결과로 선박장거리추적식별장치(LRIT)에 대한 SOLAS 성능기준안 초안이 MSC. 81차 회의에 승인을 받기 위하여 제출되었다. LRIT는 선박자동식별장치(AIS)와 함께 모든 SOLAS 대상선박에 대한 선박모니터링시스템(VMS)에 중요한 데이터를 제공할 것이다. 본 연구는 AIS 및 LRIT의의 국제적인 동향을 조사하고, 이와 관련하여 최근 이슈가 되고 있는 전자항해 시스템의 성공적인 도입을 위한 추진방향 및 비전을 제시하고자 한다.

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1,500MW대형원전 정지/저출력 안전성향상을 위한 설계개선안 및 민감도 분석 (Risk and Sensitivity Analysis during the Low Power and Shutdown Operation of the 1,500MW Advanced Power Reactor)

  • 문호림;한덕성;김재갑;이상원;임학규
    • 한국압력기기공학회 논문집
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    • 제15권1호
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    • pp.33-39
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    • 2019
  • An 1,500MW advanced power reactor required the standard design approval by a Korean regulatory body in 2014. The reactor has been designed to have a 4-train independent safety concept and a passive auxiliary feedwater system (PAFS). The full power risk or core damage frequency (CDF) of 1,500MW advanced power reactor has been reduced more than that of APR1400. However, the risk during the low power and shutdown (LPSD) operation should be reduced because CDF of LPSD is about 4.7 times higher than that of internal full power. The purpose of paper is to analysis design alternatives to reduce risk during the LPSD. This paper suggests design alternatives to reduce risk and presents sensitivity analysis results.

Health Personnel's Knowledge, Attitudes, and Self-Efficacy Related to Providing Palliative Care in Persons with Chronic Diseases

  • Cha, EunSeok;Lee, Sojung;Lee, Jooseon;Lee, Insil
    • Journal of Hospice and Palliative Care
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    • 제23권4호
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    • pp.198-211
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    • 2020
  • Purpose: The purpose of this study was to examine the relationships of knowledge, attitudes, and self-efficacy related to palliative care among health care providers (doctors and nurses) in order to provide a basis to develop a training program for health care providers. Methods: A correlational and descriptive study design was used. Participants were recruited from a university-affiliated hospital located in Daejeon and an e-nurse community. After IRB approval, data were collected from July 12, 2018, to September 30, 2018. A total of 169 responses were finally analyzed using version SPSS 24. The data were analyzed in terms of descriptive statistics (frequency and percentage or mean and standard deviation, as appropriate), the t-test, analysis of variance (with the Duncan post hoc test), and Pearson correlation coefficients. Results: Knowledge, attitudes, and self-efficacy were significantly higher in those who had received palliative care training or had been exposed to awareness-raising initiatives. There were positive relationships among knowledge, attitudes, and self-efficacy, with small to moderate effect sizes. Conclusion: Palliative care training for health care professionals is necessary to meet patients' needs. Such programs should take into account not only knowledge about palliative care, but also ways to improve empathy and resolve ethical dilemmas. Interprofessional training would be an excellent option to share therapeutic goals and develop communication skills among multidisciplinary team members.

스마트 자동차 보안 인증제도 개선방안 (The Improvement of Security Certification System for Smart Car)

  • 권순범;최선영;이환수
    • 한국IT서비스학회지
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    • 제22권3호
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    • pp.49-63
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    • 2023
  • The inclusion of software and wireless communication devices in vehicles has raised concerns regarding automobile security. In its response, UNECE WP.29 implemented the first-ever international standard for automotive cyber security in June 2020. Yet, the existing disparity between national standards for automotive certification systems and 「UN Regulation No. 155」 has caused confusion among auto makers. This discrepancy not only jeopardizes the security of domestic vehicles but also poses challenges to the seamless import and export of automobiles. Hence, there is a need to enhance the automotive cyber security certification system; however, there is a dearth of scholarly discourse on this topic. Consequently, this study presents a proposal for enhancing the domestic automotive cyber security certification system. In view of this, existing legal frameworks such as the 「Motor Vehicle Management Act」 and the 「Self-Driving Vehicle Act」 were reviewed, along with domestic and international automotive certification systems. The recommendations for improvement, derived from the findings, encompass institutional, legal, and operational aspects. This study is highly significant as it examines both domestic and international automotive certification systems in an area where there is a lack of academic discussion.

한약제제, 생약제제와 천연물신약의 법규상 개념 및 정의의 문제점과 개선안 (A study on the Problems and Improvement Proposals on Legal Definitions in Respect of Herbal Medicinal Preparations, Crude Drug Preparations and New Drugs from Natural Products)

  • 엄석기
    • 대한한의학원전학회지
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    • 제27권4호
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    • pp.181-198
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    • 2014
  • Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

Validity and Reliability of Korean Version of Behavior Problems Inventory in Autism Spectrum Disorder and/or Intellectual Developmental Disorder

  • Hwang, Samuel Suk-Hyun;Park, Jangho;Kim, Sohee;Lee, Gayoung;Kim, Yeni;Bhang, Soo-Young
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • 제29권1호
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    • pp.7-13
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    • 2018
  • Objectives: Problem behaviors pose a great obstacle to daily functioning in children with neurodevelopmental deficits and are an important target for treatment. In this study, we translated the Behavior Problems Inventory (BPI)-01 into Korean language and tested its psychometric properties. Methods: We attained the approval of the BPI author and performed standard translation-back translation. Then, professional caregivers examined appropriateness according to cultural and situational contexts in order to make necessary modifications of the Korean version of the BPI. Results: The BPI-01, Korea-Scales of Independent Behavior-Revised (K-SIB-R), and Child Behavior Checklist were completed for 98 autistic spectrum disorder or intellectual development disorder participants (mean age=28.3, standard deviation=7.3, range=10.1-51.7). The inter-rater reliability of the BPI-01 was found to be high (r=0.992-1.000). As for the results for concurrent validity for subscale items of BPI-01 and scales of SIB, correlations between SIB and BPI-01 subscales were statistically significant (r=0.357-0.672). Discussion: The Korean version of the BPI-01 showed good psychometric properties with high reliability and sufficient convergent validity. Further examination of the validity of BPI-01 should be carried out with inclusion of younger aged children and a closer look at less frequently occurring symptoms.

도시형 대안학교의 공간구성 및 이용현황 분석 (The Analysis of Spatial Organization and Using Status of Urban Alternative School)

  • 이민선;정진주
    • 교육시설
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    • 제16권4호
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    • pp.61-70
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    • 2009
  • From the mid-1990s, the discussion on alternative schools began in earnest, and with the increasing interests in them, Korean parents' association of alternative education, KPAAE was launched formally in November, 2008. Among the alternative schools in the nation, thirteen urban alternative schools were studied and analyzed. The result indicated that they are being run by individuals and civic organizations with no approval and the facilities and spatial organization of the schools are poor, which is thought to be mainly due to financial reasons as well as the schools' educational goal that puts emphasis on experiences leading to utilize outside local facilities. With this background, the results from the analysis of the facility status and the spatial organization of urban alternative schools led us to understand the followings: First, it showed that per capita average of area of the urban alternative school is approximately 11.995m$^2$, less than 14N, the standard area of institutional schools. Second, depending on the form of facilities, the space of other facilities is shared to make up for insufficient space, and is utilized to a small degree and for multi-purposes. Third, the space reflects the disposition of subject students, and is located in the area with convenient traffic for students' attending the schools conveniently. Fourth, specialized space is run on the basis of educational goals, and the exploring of career and the improving of sociality are pursued through internship programs associated with local facilities. Thus, it is desirable for the minimum per capita area of the urban alternative school to meet 14N, the standard area of the institutional schools in order that the urban alternative school may overcome the spatial limitation and the financial hardship stemming from the practically difficult constructing of new buildings and the small scale operation, and it may make flexible use of the space, and the students may live their lives smoothly. Also, it is thought that for the activating of the urban alternative schools, the plans for utilizing various facilities associated with local facilities should be considered.

신규 일반 최상위 도메인의 도입과 통일신속정지제도(URS)에 대한 연구 (New gTLD Program: Uniform Rapid Suspension System and Trademark Clearinghouse)

  • 박유선
    • 한국중재학회지:중재연구
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    • 제21권2호
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    • pp.113-131
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    • 2011
  • Recently, the Internet Corporation for Assigned Names and Numbers (ICANN) announced the expansion of the number of generic top-level domains (gTLDs) beyond the current 22 gTLDs, and the gTLD Applicant Guidebook for ICANN's new gTLD program is now under consideration for approval. ICANN also introduces a "Trademark Clearinghouse" and the "Uniform Rapid Suspension (URS)" procedure to protect trademarks and expedite dispute resolution and save costs. The Trademark Clearinghouse is a central repository for information to be authenticated, stored and disseminated, pertaining to the rights of the trademark holders. Trademark holders would voluntarily provide data of their trademarks from all over the world, and it would assist a trademark watch service provided by the new gTLD registry for trademark holders and potential domain name registrants. The URS is a part of the new gTLD dispute resolution mechanisms created by ICANN to resolve cybersquatting disputes. A complainant in a URS proceeding must establish three elements that are very similar to the existing UDRP to succeed, but supposedly more expedited and cost efficient. Since the URS provides that it only protects court validated and registered trademarks, it is not clear whether unregistered marks used in commerce are protected under the URS. The URS escalates the complainant's burden of proof from a preponderance of evidence standard under the UDRP to a clear and convincing evidence standard. The notices to a respondent shall be sufficient if the URS Provider sends the notice of Complaint to the addresses listed in the Whois contact information. As registrants who wish to conceal their true identity often subscribe to the privacy/proxy service and the complainant's high rate of success in the UDRP proceeding is relevant to the respondents' default rate, the URS's simple notice requirement would deprive respondents of a fair opportunity to assert their rights over the disputed domain names.

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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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