• Title/Summary/Keyword: regulatory agency

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Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices (임상에서 사용중인 체외충격파쇄석기의 음향 출력 분포)

  • Jong Min Kim;Oh Bin Kwon;Jin Sik Cho;Sung Joung Jeon;Ki Il Nam;Sung Yong Cho;Min Joo Choi
    • The Journal of the Acoustical Society of Korea
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    • v.42 no.5
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    • pp.469-490
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    • 2023
  • Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

Application of peak based-Bayesian statistical method for isotope identification and categorization of depleted, natural and low enriched uranium measured by LaBr3:Ce scintillation detector

  • Haluk Yucel;Selin Saatci Tuzuner;Charles Massey
    • Nuclear Engineering and Technology
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    • v.55 no.10
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    • pp.3913-3923
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    • 2023
  • Todays, medium energy resolution detectors are preferably used in radioisotope identification devices(RID) in nuclear and radioactive material categorization. However, there is still a need to develop or enhance « automated identifiers » for the useful RID algorithms. To decide whether any material is SNM or NORM, a key parameter is the better energy resolution of the detector. Although masking, shielding and gain shift/stabilization and other affecting parameters on site are also important for successful operations, the suitability of the RID algorithm is also a critical point to enhance the identification reliability while extracting the features from the spectral analysis. In this study, a RID algorithm based on Bayesian statistical method has been modified for medium energy resolution detectors and applied to the uranium gamma-ray spectra taken by a LaBr3:Ce detector. The present Bayesian RID algorithm covers up to 2000 keV energy range. It uses the peak centroids, the peak areas from the measured gamma-ray spectra. The extraction features are derived from the peak-based Bayesian classifiers to estimate a posterior probability for each isotope in the ANSI library. The program operations were tested under a MATLAB platform. The present peak based Bayesian RID algorithm was validated by using single isotopes(241Am, 57Co, 137Cs, 54Mn, 60Co), and then applied to five standard nuclear materials(0.32-4.51% at.235U), as well as natural U- and Th-ores. The ID performance of the RID algorithm was quantified in terms of F-score for each isotope. The posterior probability is calculated to be 54.5-74.4% for 238U and 4.7-10.5% for 235U in EC-NRM171 uranium materials. For the case of the more complex gamma-ray spectra from CRMs, the total scoring (ST) method was preferred for its ID performance evaluation. It was shown that the present peak based Bayesian RID algorithm can be applied to identify 235U and 238U isotopes in LEU or natural U-Th samples if a medium energy resolution detector is was in the measurements.

A Study on the Implications of Korea Through the Policy Analysis of AI Start-up Companies in Major Countries (주요국 AI 창업기업 정책 분석을 통한 국내 시사점 연구)

  • Kim, Dong Jin;Lee, Seong Yeob
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.19 no.2
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    • pp.215-235
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    • 2024
  • As artificial intelligence (AI) technology is recognized as a key technology that will determine future national competitiveness, competition for AI technology and industry promotion policies in major countries is intensifying. This study aims to present implications for domestic policy making by analyzing the policies of major countries on the start-up of AI companies, which are the basis of the AI industry ecosystem. The top four countries and the EU for the number of new investment attraction companies in the 2023 AI Index announced by the HAI Research Institute at Stanford University in the United States were selected, The United States enacted the National AI Initiative Act (NAIIA) in 2021. Through this law, The US Government is promoting continued leadership in the United States in AI R&D, developing reliable AI systems in the public and private sectors, building an AI system ecosystem across society, and strengthening DB management and access to AI policies conducted by all federal agencies. In the 14th Five-Year (2021-2025) Plan and 2035 Long-term Goals held in 2021, China has specified AI as the first of the seven strategic high-tech technologies, and is developing policies aimed at becoming the No. 1 AI global powerhouse by 2030. The UK is investing in innovative R&D companies through the 'Future Fund Breakthrough' in 2021, and is expanding related investments by preparing national strategies to leap forward as AI leaders, such as the implementation plan of the national AI strategy in 2022. Israel is supporting technology investment in start-up companies centered on the Innovation Agency, and the Innovation Agency is leading mid- to long-term investments of 2 to 15 years and regulatory reforms for new technologies. The EU is strengthening its digital innovation hub network and creating the InvestEU (European Strategic Investment Fund) and AI investment fund to support the use of AI by SMEs. This study aims to contribute to analyzing the policies of major foreign countries in making AI company start-up policies and providing a basis for Korea's strategy search. The limitations of the study are the limitations of the countries to be analyzed and the failure to attempt comparative analysis of the policy environments of the countries under the same conditions.

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A Study on the Power Supply and Demand Policy to Minimize Social Cost in Competitive Market (경쟁시장 하에서 사회적 비용을 고려한 전력수급정책 방향에 관한 연구)

  • Kwon, Byung-Hun;Song, Byung Gun;Kang, Seung-Jin
    • Environmental and Resource Economics Review
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    • v.14 no.4
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    • pp.817-838
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    • 2005
  • In this paper, the resource adequacy as well as the optimum fuel mix is obtained by the following procedures. First, the regulation body, the government agency, determine the reliability index as well as the optimum portfolio of the fuel mix during the planning horizon. Here, the resources with the characteristics of public goods such as demand-side management, renewable resources are assigned in advance. Also, the optimum portfolio is determined by reflecting the economics, environmental characteristics, public acceptance, regional supply and demand, etc. Second, the government announces the required amount of each fuel-type new resources during the planning horizon and the market participants bid to the government based on their own estimated fixed cost. Here, the government announces the winners of the each auction by plant type and the guaranteed fixed cost is determined by the marginal auction price by plant type. Third, the energy market is run and the surplus of each plant except their cost (guaranteed fixed cost and operating cost) is withdrew by the regulatory body. Here, to induce the generators to reduce their operating cost some incentives for each generator is given based on their performance. The performance is determined by the mechanism of the performance-based regulation (PBR). Here the free-riding performance should be subtracted to guarantee the transparent competition. Although the suggested mechanism looks like very regulated one, it provides two mechanism of the competition. That is, one is in the resource construction auction and the other is in the energy spot market. Also the advantages of the proposed method are it guarantee the proper resource adequacy as well as the desired fuel mix. However, this mechanism should be sustained during the transient period of the deregulation only. Therefore, generation resource planning procedure and market mechanisms are suggested to minimize possible stranded costs.

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International Legal Regulation on Commercial Space Activity (상업적 우주활동의 국제법적 규제)

  • Lee, Young-Jin
    • The Korean Journal of Air & Space Law and Policy
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    • v.28 no.2
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    • pp.183-221
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    • 2013
  • While in the early stages of space activities only a few states engaged in the use of outer space, as is well known, commercial space activities have grown dramatically in recent years. Both states, state institutions, and international governmental organizations as well as many private enterprises are engaged in such commercial use of outer space by now. This development is not reflected in the present state of space law. The existing international instruments of space law were developed and finalized before this development and thus only provide very few and sometimes unfitting provisions for the commercial use of outer space and particularly the use by private enterprises. Law formulated in an era when the word "privatization" had not even been coined cannot contain potential problems caused by the increasing commercialization of outer space. For the promotion and further development of such commercial use of outer space it is necessary to clarify and establish the legal framework for such use, because participants will need this information for their future investments in this field. The purpose of this paper is to research and make an analysis of the contents and international regulation of international space commerce, which is rapidly proliferating and to review the process of improvement on national legislations relating to the commercialization of outer space in a few main space advanced countries to make the sustainable progress of commercial space activities project in international society. The legal implications of matters such as international commercial launch services, the liability aspects of such services, intellectual property rights, insurance, product liability insurance and materials processing could one day will be subject to regulated by international space law as well as domestic law. In fact, the question of commercialization is linked to the question of sharing benefits of space activities, and this currently is an agenda item in the Legal Subcommittee of UN COPUOS. Most of developed countries have enacted the national legislation for commercial space activities relating to the development of our space as follows : The National Aeronautic and Space Act of 1958 and the Commercial Space Act of 1998 in the United States, Outer Space Act of 1986 in England, Establishment Act of National Space Center of 1961 in France, Canadian Space Agency Act of 1990 in Canada, Space Basic Act of 2008 in Japan, and Law on Space Activity of 1993 in Russia. Becides there are currently three national legislations relating to space development and commercial space activities in Korea as follows : Aerospace Industry Development Promotion Act of 1987, Outer Space Development Promotion Act of 2005, Outer Space Damage Compensation Act of 2008. Commercial space great promise for the utilization and expansion of human outer space activities but aspring commercial actors must recognize that foreign policy, as well as obligations to the international community as a whole, ensure that commercial space activities will not operate in a legal and regulatory vacuum. As commercial space matures the law and accompanying regulation will most certainly evolve and choose to become participants in the inevitable evolution of law and regulation.

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A Study on the Legal Proposal of Crew's Fatigue Management in the Aviation Regulations (항공법규에서의 승무원 피로관리기준 도입방안에 관한 연구 - ICAO, FAA, EASA 기준을 중심으로 -)

  • Lee, Koo-Hee;Hwang, Ho-Won
    • The Korean Journal of Air & Space Law and Policy
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    • v.27 no.1
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    • pp.29-73
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    • 2012
  • Aviation safety is the State and industry's top priority and more scientific approaches for fatigue management should be needed. There are lately various studies and regulation changes for crew fatigue management with ICAO, FAA and EASA. ICAO issued the provisions of fatigue management for flight crew since 1st edition, 1969, of Annex 6 operation of aircraft as a Standards and Recommended practice(SARPs). Unfortunately, there have been few changes and improvement to fatigue management provisions since the time they were first introduced. However the SARPs have been big changed lately. ICAO published guidance materials for development of prescriptive fatigue regulations through amendment 33A of Annex 6 Part 1 as applicable November 19th 2009. And then ICAO introduced additional amendment for using Fatigue Risk Management System (FRMS) with $35^{th}$ amendment in 2011. According to the Annex 6, the State of the operator shall establish a) regulations for flight time, flight duty period, duty period and rest period limitations and b) FRMS regulations. The Operator shall implement one of following 3 provisions a) flight time, flight duty period, duty period and rest period limitations within the prescriptive fatigue management regulations established by the State of the Operator; or b) a FRMS; or c) a combination of a) and b). U.S. FAA recently published several kinds of Advisory Circular about flightcrew fatigue. U.S. passed "Airline Safety and FAA Extension Act of 2010" into law on August 1st, 2010. This mandates all commercial air carriers to develop a FAA-acceptable Fatigue Risk Management Plan(FRMP) by October 31st, 2010. Also, on May 16, 2012, the FAA published a final rule(correction) entitled 'Flightcrew Member Duty and Rest Requirements; correction to amend its existing prescriptive regulations. The new requirements are required to implement same regulations for domestic, flag and supplemental operations from January 4, 2014. EASA introduced a Notice of Proposed Amendment (NPA) 2010-14 entitled "Draft opinion of the European Aviation Safety Agency for a Commission Regulation establishing the implementing rules on Flight and Duty Time Limitations and Rest Requirements for Commercial Air Transport with aeroplanes" on December 10, 2010. The purpose of this NPA is to develop and implement fatigue management for commercial air transport operations. Comparing with Korean and foreign regulations regarding fatigue management, the provisions of ICAO, FAA, EASA are more considering various fatigue factors and conditions. Korea regulations should be needed for some development of insufficiency points. In this thesis, I present the results of the comparative study between domestic and foreign regulations in respect of fatigue management crew member. Also, I suggest legal proposals for amendment of Korea Aviation act and Enforcement Regulations concerning fatigue management for crew members. I hope that this paper is helpful to change korea fatigue regulations, to enhance aviation safety, and to reduce the number of accidents relating to fatigue. Fatigue should be managed at all level such as regulators, experts, operators and pilots. Authority should change surveillance mind-set from regulatory auditor to expert adviser. Operators should identify various fatigue factors and consider to crew scheduling them. Crews should strongly manage both individual and duty-oriented fatigue issues.

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A Study on Aviation Safety and Third Country Operator of EU Regulation in light of the Convention on international Civil Aviation (시카고협약체계에서의 EU의 항공법규체계 연구 - TCO 규정을 중심으로 -)

  • Lee, Koo-Hee
    • The Korean Journal of Air & Space Law and Policy
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    • v.29 no.1
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    • pp.67-95
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    • 2014
  • Some Contracting States of the Chicago Convention issue FAOC(Foreign Air Operator Certificate) and conduct various safety assessments for the safety of the foreign operators which operate to their state. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident. FAOC also burdens the other contracting States to the Chicago Convention due to additional requirements and late permission. EASA(European Aviation Safety Agency) is a body governed by European Basic Regulation. EASA was set up in 2003 and conduct specific regulatory and executive tasks in the field of civil aviation safety and environmental protection. EASA's mission is to promote the highest common standards of safety and environmental protection in civil aviation. The task of the EASA has been expanded from airworthiness to air operations and currently includes the rulemaking and standardization of airworthiness, air crew, air operations, TCO, ATM/ANS safety oversight, aerodromes, etc. According to Implementing Rule, Commission Regulation(EU) No 452/2014, EASA has the mandate to issue safety authorizations to commercial air carriers from outside the EU as from 26 May 2014. Third country operators (TCO) flying to any of the 28 EU Member States and/or to 4 EFTA States (Iceland, Norway, Liechtenstein, Switzerland) must apply to EASA for a so called TCO authorization. EASA will only take over the safety-related part of foreign operator assessment. Operating permits will continue to be issued by the national authorities. A 30-month transition period ensures smooth implementation without interrupting international air operations of foreign air carriers to the EU/EASA. Operators who are currently flying to Europe can continue to do so, but must submit an application for a TCO authorization before 26 November 2014. After the transition period, which lasts until 26 November 2016, a valid TCO authorization will be a mandatory prerequisite, in the absence of which an operating permit cannot be issued by a Member State. The European TCO authorization regime does not differentiate between scheduled and non-scheduled commercial air transport operations in principle. All TCO with commercial air transport need to apply for a TCO authorization. Operators with a potential need of operating to the EU at some time in the near future are advised to apply for a TCO authorization in due course, even when the date of operations is unknown. For all the issue mentioned above, I have studied the function of EASA and EU Regulation including TCO Implementing Rule newly introduced, and suggested some proposals. I hope that this paper is 1) to help preparation of TCO authorization, 2) to help understanding about the international issue, 3) to help the improvement of korean aviation regulations and government organizations, 4) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.