• 대한의용생체공학회:의공학회지
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• 제44권4호
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• pp.264-274
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• 2023

Purpose: The objective is to extract insights that can contribute to the formulation of harmonized international policies and support measures for innovative medical devices and management systems. This study aims to propose effective strategies for future medical device innovation and healthcare delivery. Results: It investigates technological advancements, regulatory approval systems, insurance policies, and successful commercialization cases in South Korea, the United States, and the European Union. In 2018, the FDA implemented insurance coverage for Software as a Medical Device (SaMD) and recognized insurance coverage for Digital Therapeutics (DTx). Germany is a country that ensures permanent reimbursement for healthcare applications since 2020, making it the first country to provide legal health insurance coverage for fostering a digital ecosystem. Conclusion: The findings of this research highlight the importance of cultivating a supportive regulatory and environmental framework to facilitate the adoption of innovative medical devices. Continuous support for research and development (R&D) efforts by companies, along with the validation of clinical effectiveness, is crucial.

• 대한전자공학회:학술대회논문집
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• 대한전자공학회 2001년도 The 6th International Symposium of East Asian Resources Recycling Technology
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• pp.19-23
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• 2001

In addition to landfilling and incineration, waste minimization and recycling have become priorities in Taiwan's municipal waste management strategies over the past 10 years. Major recycling initiatives being implemented in Taiwan include producer responsibility, "pay-as-you-throw, " and mandatory sorting provisions. Currently, the producer responsibility regime established under the Waste Disposal Act and administered by the Environmental Protection Administration (EPA) requires that manufacturers or importers of listed items, including containers, batteries. cars, motorcycles ("scooters"), tires, oil, televisions, refrigerators, air conditioners, washing machines, computers, and printers, pay recycling fees to government recycling funds. EPA then uses the recycling funds to subsidize collection and recycling. The 2001 recycling fund budget totals NT$57 billion (NT$35 = US$l). Under the producer responsibility regime, EPA-designated retailers ("sellers") must accept end-of-life items returned to them by the consumers. At the local level, Taipei City implements a pay-as-you-throw program, whereby citizens pay waste collection and treatment fees through the purchase of special trash bags approved by the Taipei City Government. However. recyclables that are separated by citizens are collected free-of-charge by the City. Taichung City and Kaohsiung City, on the other hand, enforce mandatory sorting schemes, whereby citizens face penalties if they don't separate recyclables from the trash before pick-up. These programs have resulted in a significant reduction in municipal waste. Per capita waste collected per day has dropped from 1.143 kg in 1997 to 0.978 kg in 2000. Targeting a 10% recycling rate for municipal waste in 2001. EPA plans to research and develop new recycling techniques, expand the scope of producer responsibilities, and strengthen existing municipal recyclable collection programs. To this end, among other initiatives, EPA has prepared a draft "Resource Recycling and Reuse Act" that would complement the existing producer responsibility programs by incorporating into the current recycling framework the concept of product life-cycle management.

• Journal of Forest and Environmental Science
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• 제25권3호
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• pp.139-146
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• 2009

Forest parks are regarded as one of the scientific ways to keep the forest sustainably developed, meanwhile deliver the benefits to the general public. The development of forest parks in China has experienced simply more than 20 years and both the exploitation and management institutions haven't been set up systematically, which, in reality, reflects as inadequate legislative and policy framework. Without the regulatory guidance and collaborating assistance of environment relating governmental sectors at both national and local levels, it's inevitable that the development of forest parks in the country would face constant problems and conflicts. Therefore, it might be helpful to sort out this conflicts and problems and further more to work out how to solve the barriers. The research in this report started with introducing the IUCN Protected Areas Categories, the overall current situations in China and compared the definition of forest parks in the country and that in international experience. It is to aim to find out the real usufruct rights conflicts during the exploitation and management of forest parks and the method used in this report is field visit, previous investigation, collecting secondary materials, interview, analysis and comparison. The research result in this report couldn't cover all the conflict situations during the forest parks' exploitation and management in China but will provide the analysis of this problem from the legal perspective. Practical application and concerning suggestion will be fully discussed in Part 5 in terms of legislative, social and environmental effects.

• Journal of Ship and Ocean Technology
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• 제12권4호
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• pp.32-39
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• 2008

According to the increase of the requirement for the safety and environmental protection at sea, safety is a core design factor of maritime systems. Safety is defined as a perceived quality that determines to what extent the management, engineering and operation of a system is free of danger to life, property and the environment. There are many possible approaches in dealing with the safety of ships. The risk-based approach is one of the most systematic and reasonable way currently in design, operation and regulatory works for ship safety. This paper proposes a concept of total risk management for ship safety, and introduces a prototype system implemented based on this concept as a framework of design and operation of ships.

• Advances in environmental research
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• 제12권1호
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• pp.41-49
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• 2023

In developing countries, solid waste is typically disposed of inappropriately, which has a negative impact on the environment and healthcare. One of the most serious environmental issues is the management of municipal solid waste because of the huge increase in waste generation brought on by industrialization, economic development, urbanization, and the exponential growth of Gurugram City's population. Municipal Corporation Gurugram (MCG) handles solid waste collection, transportation, and disposal. The city generates over 1100 tons of solid waste per day. In consideration of this, the current study employed the strengths, weaknesses, opportunities, and threats framework called SWOT analysis to critically examine the city's current methods for the management of municipal solid waste to provide more effective policy solutions. For conducting the analysis, the questionnaires and other interviews were conducted to gather information from households and officials in the city, and the observation made during field visits were recorded. The analysis shows that the waste management issue is getting worse for a variety of causes, including a lack of regulatory enforcement, insufficient technical and financial resources, insufficient people's participation, inadequate execution of policies, a lack of political priorities, and poor coordination between authorities.

• 한국물환경학회지
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• 제23권5호
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• pp.766-775
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• 2007

The use of toxic chemicals was extended as the industry in Korea has grown dramatically during the last three decades. However, list of toxic substances and limit concentrations in the water environment are not consistent within management of ambient water, drinking water and industrial effluent. This article suggests the systematic framework to classify toxic substances in the water environment and deriving their effluent limits. The most important factor for decision-making to classify toxic substances is whether their concentrations in the water environment are higher than the reference concentrations, estimated by considering human health risk and ecological risk. Using a risk-based reference concentration, the ambient water quality criterion, it is possible to derive the regulatory limit concentrations of toxic substances in drinking water and in industrial effluent. The goal concentrations in the effluent, which guarantee the human and ecological safety, should be determined with scientific investigation, balancing environmental benefit and economical effect, considering availability of treatment technology and identifying characteristics of wastewater from different industries.

• 과학기술학연구
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• 제10권2호
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• pp.143-174
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• 2010

과학적 불확실성이 존재하는 상황에서 위험에 대응하는 규제 정책의 정당성을 어떻게 확보할 수 있을까? 이런 중요한 물음과 관련해 70년대 이후 유럽을 중심으로 사전주의의 원칙이 하나의 대안으로 부상해왔고 국제 환경법 분야에서는 주요 원리로 인정받아왔다. 하지만 이 원칙은 그 정의의 모호함 때문에 위험분석 옹호자들로부터 다양한 비판을 받아왔다. 이 논문은 이런 여러 비판들의 적실성과 부당함을 함께 평가하면서 사전주의의 원칙의 정교화작업을 시도할 것이다. 그리고 이런 작업을 통해 얻은 결과를 위험 거버넌스 중 과학적 영역으로 흔히 인정받는 위험평가에 적용해봄으로써 이 원칙의 정책적 활용 가능성을 탐색해볼 것이다. 특히, 사전주의의 원칙은 단지 도덕적 태도이거나 정치적 입장일 뿐이라는 일부 시각을 반박하면서 이 원칙이 실제 과학적 활동 속에서 충분히 적용가능한 실제적 원리임을 강조할 것이다.

• 방사성폐기물학회지
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• 제6권4호
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• pp.357-368
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• 2008

국내 최초의 중 저준위 방사성폐기물 처분시설에 대한 건설 운영허가가 지난 2008년 7월 31일 발급되었다. 이 논문에서는 중 저준위 방사성폐기물 처분시설에 대한 국내 기본 규제체계, 규제요건 및 기술기준을 제시하고, 동 시설의 안전성 확인을 위해 실제 적용된 안전심사수행절차를 주요 단계별로 기술하였다. 원자력법은 부지선정, 설계, 건설, 운영, 폐쇄 및 제도적관리 등 중 저준위 방사성폐기물 처분시설의 전과정에 대한 단계별 안전규제체계를 규정하고 있으며, 하위 법령과 교육과학기술부고시 등은 관련 세부 규제요건 및 기술기준을 규정하고 있다. 한국원자력안전기술원은 원자력관계법령에 근거한 교육과학기술부의 위탁에 따라 처분시설에 대한 안전심사를 수행하였으며, 부지 및 구조안전성, 방사선환경 영향, 운영 안전성, 계통 및 설비의 안전성, 품질보증, 종합안전성평가 등 세부 기술 분야별 적합성을 종합적으로 검토하였다. 전체 안전심사 과정은 사전준비단계, 초기심사단계, 본심사단계, 완료단계 등으로 구분할 수 있으며, 한국원자력안전기술원의 심사결과는 원자력안전전문위원회 5개 전문분과의 심의를 거쳐 교육과학기술부에 보고되었고, 교육과학기술부는 원자력안전위원회의 최종 심의를 통해 처분시설에 대한 건설 운영허가를 발급하였다. 이후 처분시설의 안전성은 원자력관계법령에 규정된 일련의 규제검사 및 심사를 통해 확인될 것이며, 건설 운영자의 지속적인 안전성증진계획 이행을 통해 장기적인 안전성 증진과 안전사례에 대한 신뢰구축이 가능할 것이다.

• Safety and Health at Work
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• 제12권4호
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• pp.462-470
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• 2021

Background: Fatigue is pervasive, under-reported, and potentially deadly where flight operations are concerned. The aviation industry appears to lack a standardized, practical, and easily replicable protocol for fatigue risk assessment which can be consistently applied across operators. Aim: Our paper sought to present a framework, supported by real-world data with subjective and objective parameters, to monitor aircrew fatigue and performance, and to determine the safe crew configuration for commercial airline operations. Methods: Our protocol identified risk factors for fatigue-induced performance degradation as triggers for fatigue risk and performance assessment. Using both subjective and objective measurements of sleep, fatigue, and performance in the form of instruments such as the Karolinska Sleepiness Scale, Samn-Perelli Crew Status Check, Psychomotor Vigilance Task, sleep logs, and a wearable actigraph for sleep log correlation and sleep duration and quality charting, a workflow flagging fatigue-prone flight operations for risk mitigation was developed and trialed. Results: In an operational study aimed at occupational assessment of fatigue and performance in airline pilots on a three-men crew versus a four-men crew for a long-haul flight, we affirmed the technical feasibility of our proposed framework and approach, the validity of the battery of assessment instruments, and the meaningful interpretation of fatigue and work performance indicators to enable the formulation of safe work recommendations. Conclusion: A standardized occupational assessment protocol like ours is useful to achieve consistency and objectivity in the occupational assessment of fatigue and work performance.

• Nuclear Engineering and Technology
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• 제50권8호
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• pp.1199-1209
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• 2018

After the Fukushima-Daiichi accident in 2011, the multi-unit risk, i.e., the risk due to several nuclear power plants (NPPs) in a site has become an important issue in several countries such as Korea, Canada, and China. However, the multi-unit risk has been discussed for a long time in the nuclear community before the Fukushima-Daiichi nuclear accident occurred. The regulatory authorities around the world and the international organizations had proposed requirements or guidelines to reduce the multi-unit risk. The concerns regarding the multi-unit risk can be summarized in the following three questions: How much the accident of an NPP in a site affects the safety of other NPPs in the same site? What is the total risk of a site with many NPPs? Will the risk of the simultaneous accidents at several NPPs in a site such as the Fukushima Daiichi accident be low enough? The multi-unit risk assessment (MURA) in an integrated framework is a practical approach to obtain the answers for the above questions. Even though there were few studies to assess the multi-unit risk before the Fukushima-Daiichi nuclear accident, there are still several issues to be resolved to perform the complete MURA. This article aims to provide an overview of the multi-unit risk issues and its assessment. We discuss the several critical issues in the current MURA to get useful insights regarding the multi-unit risk with the current state art of probabilistic safety assessment (PSA) technologies. Also, the qualitative answers for the above questions are addressed.