• 제목/요약/키워드: regulatory guideline

검색결과 66건 처리시간 0.019초

벤토나이트와 시멘트가 매립장 차수층의 투수성과 압축강도에 미치는 영향(I) (Effect of Bentonite and Cement on Permeability and Compressive Strength of the Compacted Soil Liner)

  • 김수문;염희남;임남웅
    • 대한환경공학회지
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    • 제22권3호
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    • pp.495-504
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    • 2000
  • 폐기물 매립지 차수층에 국내 투수계수 기준치($k=1{\times}10^{-7}cm/sec$)에 만족하는 벤토나이트와 시멘트의 적정첨가량을 알아보았다. 차수층의 모토는 토양 통일 분류법에 따라 CL 토양과 SM 토양을 사용하여 투수(KSF 2322)와 압축강도(KSF 2314)를 시험하였다. 실험결과, 국내 투수계수(k) 기준치에 만족하기 위해서는, CL 토양에는 벤토나이트 5%와 시멘트 5%를 첨가할 때, $k=9.98{\times}10^{-8}$이었고 ${\sigma}_{28}$$12.25kg/cm^2$이었다. SM 토양에서는 벤토나이트 15%와 시멘트 5%를 첨가하였을 때, k값은 $9.86{\times}10^{-7}cm/sec$이었으며 ${\sigma}_{28}$$18.72kg/cm^2$이었다. 따라서, 폐기물 매립지 차수층 건설에서, 적정량의 벤토나이트와 시멘트를 CL과 SM형 차수층 모토에 혼합할 때 국내 투수 기준치에 만족하였다.

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단지특성에 따른 국민임대주택 커뮤니티시설의 거주자 이용 실태에 관한 연구 (Residents' Usage of Community Facilities by Types of National Rental Apartment Complexes)

  • 황연숙;장윤정;손여림;장아리
    • 한국실내디자인학회논문집
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    • 제18권5호
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    • pp.147-155
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    • 2009
  • The purpose of this study is to examine the residents' preference to community facilities in national rental apartment complexes. Twelve housing complexes were sampled and researched with questionnaire and field-surrey methods. The data from the questionnaire survey were processed with SPSS 14 and analyzed by regional group, size of complex, and arrangement plan of facilities. The complexes are located in two legions, Seoul and Gyounggi province. They were also sorted into three groups by size: less than 500 households, 500 to 1,000, and more than 1,000. Lastly, the complexes were categorized into three types: those where facilities are concentrated in or around a single building, dispersed into several places, and located in residential buildings. The results are as follows: Majority of the community facilities are established outdoor and, therefore, the indoor facilities are relatively more insufficient. Especially, there is a shortage of indoor gymnasium while the demand is increasing. It is partly because there is no regulatory guideline on indoor gym requirements in housing complexes. The resident satisfaction measurement shows significant comparison according to region and complex size. The level of satisfaction with garden/kitchen-garden, pond/fountain/streamlet is higher at the complexes in Gyunggi. The residents of larger complexes give positive feedback about spells facilities while those of smaller complexes are more satisfied with education-related facilities such as library and study. The measurement of resident needs shows significant comparison according to complex size and facility arrangement plan. The residents of smaller complexes are more in need of community facilities. In both regulatory standards and actual condition, community facilities are more insufficient at small complexes with less than 500 households.

장기이식 거부반응과 자가면역질환 치료제로서의 CAR Treg 세포치료제의 가능성: Treg 세포치료제 임상시험 현황과 CAR T 세포치료제 허가 정보를 바탕으로 (Current Perspectives on Emerging CAR-Treg Cell Therapy: Based on Treg Cell Therapy in Clinical Trials and the Recent Approval of CAR-T Cell Therapy)

  • 강고은;정준호;양재석;김효리
    • 대한이식학회지
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    • 제31권4호
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    • pp.157-169
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    • 2017
  • Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.

SaMD에 대한 휴리스틱 기반 사용적합성 평가 가이드라인 개발 (Development of Guideline for Heuristic Based Usability Evaluation on SaMD)

  • 김종엽;김정현;김재호;정명진
    • 대한의용생체공학회:의공학회지
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    • 제44권6호
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    • pp.428-442
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    • 2023
  • In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

국내 동물의 야생생태계 방출로 인한 위해성 및 위해성 관리방안 (Risks Incurred by Release of Animals into the Natural Ecosystem in Korea and Its Risk Management)

  • 방상원;김애선
    • 환경정책연구
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    • 제10권1호
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    • pp.3-25
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    • 2011
  • 최근 국내에서는 지방자치단체나 민간단체들에 의하여 동물을 야생생태계로 방출하는 사업이 일종의 유행처럼 증가하고 있다. 2002년에 야생생태계로 방출된 동물은 포유류와 조류에 불과하였으나 2007년는 포유류, 조류를 비롯하여 어류, 양서류, 파충류, 무척추동물 등으로 확대되는 등 방출되는 동물의 종류가 증가하고 그 개체수도 증가하고 있다. 그러나 국내의 방출사업의 경우, 본래 그 지역 야생생태계에서 역사적으로나 생태적으로 서식하지 않았던 동물종을 방출하거나 또는 방출 후 해당 지역에 끼칠 수 있는 위해성을 사전에 평가하지 않은 채 방출함으로써 생태적, 경제적 및 공중보건적 피해들이 발생하고 있다. 이러한 피해 발생의 주된 원인으로는 방출되는 동물을 법 제도적으로 규율하는 국내의 위해성 관리기제가 부재하기 때문이다. 이에 반해 선진국들은 동물의 야생생태계 방출로 인한 피해를 사전에 예방하고자 자생종과 외래종을 포함한 모든 동물종의 야생생태계 방출 시에 세계자연보전연맹이 제정한 'IUCN/SSC의 재도입을 위한 지침'을 준수하거나 또는 자국 생태계 여건에 부합한 별도의 위해성 관리기제를 마련하여 방출하도록 규율하고 있다. 본고는 국내 동물의 야생생태계 방출 현황과 방출로 인한 생태적, 경제적, 공중보건적 피해 및 위해 사례에 대한 수집 분석을 통해 방출 관련 위해성 관리의 필요성을 제시하고, 국내 방출 관련 법 제도의 미비점을 파악하여 이를 선진국의 위해성 관리기제와 비교 분석함으로써 국내 여건에 맞는 방출 관련 위해성 관리방안을 제시하였다.

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중국 희토류산업정책의 변화와 정책적 함의 (Changes in China's Rare Earth Industry Policy and their Implications)

  • 박인섭;송재두
    • 무역상무연구
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    • 제71권
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    • pp.297-324
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    • 2016
  • China not only has the largest amount of rare earth reserves, but it also produces the most rare earth products. However, China lacks appropriate supervision and management systems of its rare earth industry. The Chinese government's inappropriate mechanisms have been cause for reckless development by national rare earth providers characterized by excessive competition, environmental pollution, and smuggling. In response to the problems, China implemented regulatory measures to restructure the rare earth industry. The Chinese central government intensifies its efforts to control the total quantity of rare earth products and tackle environmental pollution. Six leading conglomerates have been selected to promote the Chinese central government's policy. A new environmental guideline has been drawn up to reduce the discharging of wastewater and air pollution substance. Huge transition and a great influence of its policy changes are expected. These policy changes are bound to entail huge transitions, and the policy is expected to have a great influence in the future structure of the rare earth industry. In consideration of these changes, the Korean government, in collaboration with private enterprises needs to take appropriate measures, such as overseas resources development, R&D expansion, tactical stockpiling, professional manpower training and so on.

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국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황 (Independent Data Monitoring Committees: Review of Current Guidelines)

  • 이보람;이경은
    • 한국임상약학회지
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    • 제26권2호
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    • pp.181-186
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    • 2016
  • Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

원자력시설 해체부지의 재이용을 위한 방사선학적 리스크 평가모델 (A Mathematical Model to Evaluate the Radiological Risks for the Reuse of Decommissioning Site)

  • 정재학
    • 방사성폐기물학회지
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    • 제4권4호
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    • pp.353-363
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    • 2006
  • 원자력시설 해체부지를 재이용하는 과정에서 유발될 수 있는 방사선학적 리스크를 사전에 선별하기 위한 목적으로 단순화된 방사선량 평가모델을 개발하고, 이를 Microsoft $Excel{\circledR}$ 스프레드시트와 내장된 Visual Basic 및 마크로 기능을 활용하여 기능별로 모듈화된 평가도구를 구현하였다. 이와 함께 부지 특성자료가 불충분할 경우 신속한 사전평가를 위해 적용할 수 있는 일련의 입력변수 값 목록을 제안하였다. 동일한 조건에서 이 연구에서 개발된 평가도구를 이용해 유도한 사전 선별준위가 RESRAD Ver.6.2를 이용해 계산된 유도농도지침한계 및 독일 방사선방호령에 규정된 핵종별 부지 재이용 기준농도를 합리적으로 근사할 수 있음을 확인하였다.

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비타민 A 결핍을 통한 한우 고급육 생산 (Review: Increasing Marbling Score in Hanwoo via Feeding Vitamin A-Deficient Diets.)

  • 김완영;박진기;여준모
    • 현장농수산연구지
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    • 제17권1호
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    • pp.3-20
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    • 2015
  • Vitamin A exerts a broad range of effects on many essential life processes. But, since vitamin A is known to negatively affect the development of adipocytes, extensive research has been conducted to improve marbling score in beef cattle by feeding vitamin A-deficient diets. In Japan, the method of fattening Wagyu cattle using vitamin A-deficient diets has been widely adapted. Recently, the method of feeding vitamin A-deficient diets in Korean native cattle (Hanwoo) has been spread by feed companies and TMR plants. But proper guidelines in feeding vitamin A-deficient diets should be provided, otherwise it can adversely affect the health of cattle. To maximize marbling score, a controlled level of vitamin A in blood needs to be maintained and the proper period for feeding vitamin A-deficient diets should be adapted. This review was conducted to highlight the regulatory effects of vitamins A on adipocyte differentiation, and offer a potential guideline for improving beef quality grades in Hanwoo.

이산화탄소 포집 및 저장 실용화를 위한 국내 정책 연구 (A Study on Domestic Policy Framework for Application of Carbon Dioxide Capture and Storage(CCS))

  • 채선영;권석재
    • 해양환경안전학회지
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    • 제18권6호
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    • pp.617-625
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    • 2012
  • 본 연구는 기후변화에 대응하기 위한 이산화탄소 포집 및 저장(Carbon Dioxide Capture and Storage, CCS)기술의 국내외 추진상황 및 정책마련 현황을 점검하고 국제에너지기구(International Energy Agency, IEA)가 제시한 CCS 규제 프레임워크 가이드라인을 통해 국내 이산화탄소 해양지중저장 실용화 정책에 대한 한계 및 시사점을 제시하였다. 현재 국가차원의 계획이 마련되었으나 실질적인 법개정이나 정책마련은 이루어지지 않았으며 CCS 실용화 추진을 위하여 구성된 총괄협의체는 그 협력체제 및 유연성이 부족하다. 경제성 평가 역시 CCS 과정 별로 분절적으로만 이루어지고 있으며 향후, 실증을 위한 대규모 투자가 예상되나 이를 위한 재정은 마련되지 않고 있다. 또한, CCS 관련 정보공유도 제한적이며 체계적인 대중인식 전략은 마련되지 않은 상황이다. 따라서 성공적인 CCS 실용화 추진을 위해서는 해양환경관리법을 바탕으로 한 신속한 법적체제 마련, CCS 총괄협의체 역할 조정 및 강화, CCS 전주기를 바탕으로 한 다양한 경제 시나리오 분석 및 경제적 인센티브 제도 마련, 대중인식 전략 마련, 그리고 정보교환을 위한 전문기관 설립과 같은 정책적 보완 사항들이 필요함을 본 연구에서 제시하였다.