• Title/Summary/Keyword: Minimum standards

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GLP Bioanalysis from the US FDA Perspective

  • Wilkinson, Tames M.
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2006.11a
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    • pp.75-79
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    • 2006
  • The United States Food and Drug Administration is responsible for ensuring US residents receive safe and effective medicines. Since blood levels of drugs are correlated with pharmacological effect, FDA closely regulates how those blood levels are measured. The FDA has established requirements for bioanalytical analyses such as minimum method validation, SOP, and reporting criteria. The FDA also has standards for computer validation which must be followed to ensure the data are reliable. Data presented to the Agency are scrutinized to ensure they are accurate and a true reflection of the raw data generated in a study. To verify the quality of data, FDA has developed an inspection program. The specific requirements of the FDA related to bioanalysis will be discussed.

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Ultralow Intensity Noise Pulse Train from an All-fiber Nonlinear Amplifying Loop Mirror-based Femtosecond Laser

  • Dohyeon Kwon;Dohyun Kim
    • Current Optics and Photonics
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    • v.7 no.6
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    • pp.708-713
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    • 2023
  • A robust all-fiber nonlinear amplifying loop-mirror-based mode-locked femtosecond laser is demonstrated. Power-dependent nonlinear phase shift in a Sagnac loop enables stable and power-efficient mode-locking working as an artificial saturable absorber. The pump power is adjusted to achieve the lowest intensity noise for stable long-term operation. The minimum pump power for mode-locking is 180 mW, and the optimal pump power is 300 mW. The lowest integrated root-mean-square relative intensity noise of a free-running mode-locked laser is 0.009% [integration bandwidth: 1 Hz-10 MHz]. The long-term repetition-rate instability of a free-running mode-locked laser is 10-7 over 1,000 s averaging time. The repetition-rate phase noise scaled at 10-GHz carrier is -122 dBc/Hz at 10 kHz Fourier frequency. The demonstrated method can be applied as a seed source in high-precision real-time mid-infrared molecular spectroscopy.

A Study on Minimum Cabin Crew Requirements for Korean Low Cost Air Carriers

  • Yoo, Kyung-In;Kim, Mun-Kyung
    • The Korean Journal of Air & Space Law and Policy
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    • v.33 no.2
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    • pp.291-314
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    • 2018
  • In recent 3 years, Korea's low-cost airlines have expanded their areas of passenger transportation not only to domestic market but also to Japan, China, Southeast Asia and US territory as a total of 6 companies (8 airlines including small air operation business carriers). Currently, three more airlines have filed for air transportation business certification as future low-cost carriers, and this expansion is expected to continue. To cope with the aggressive airline operations of domestic and foreign low-cost carriers and to enhance their competitiveness, each low-cost airline is taking a number of strategies for promoting cabin service. Therefore, the workload of the cabin crew is increased in proportion to the expansion, and the fatigue directly connected with the safety task performance is increased. It is stipulated in the Enforcement Regulations of the Korea Aviation Safety Act that at minimum, one cabin crew is required per 50 passenger seating capacity, and all low cost carriers are boarding only the minimum cabin crew. Sometimes it is impossible for them to sit in a floor level emergency exit for evacuation, which is the main task of the cabin crew, and this can cause confusion among evacuating passengers in the event of an emergency. In addition, if one of the minimum cabin crew becomes incapacitated due to an injury or the like, it will become a serious impediment in performing emergency evacuation duties. Even in the normal situation, since it will be violating the Act prescription on the minimum cabin crew complement, passengers will have to move to another available airline flights, encountering extreme inconvenience. Annex 6 to the Convention on International Civil Aviation specifies international standards for the determination of the minimum number of cabin crew shall be based only on the number of passenger seats or passengers on board for safe and expeditious emergency evacuation. Thereby in order to enhance the safety of the passengers and the crew on board, it is necessary to consider the cabin crew's fatigue that may occur in the various job characteristics (service, safety, security, first aid)and floor level emergency exit seating in calculating the minimum number of cabin crew. And it is also deemed necessary for the government's regulatory body to enhance the cabin safety for passengers and crew when determining the number of minimum cabin crew by reflecting the cabin crew's workload leading to their fatigue and unavailability to be seated in a floor level emergency exit on low cost carriers.

A Review on the Performance Criteria of Equipment Required for Asbestos Removal (석면 해체.제거 작업에서 사용되는 장비의 성능 기준에 관한 고찰)

  • Lee, Naroo
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.23 no.3
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    • pp.212-221
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    • 2013
  • Objectives: Asbestos fibers are accumulated in negative pressure unit (NPU) or vacuum cleaner in asbestos removal. Failure of operation or poor use performance of the NPU or vacuum cleaner causes asbestos fibers to spread in the air. Asbestos contractors should have an NPU fitted with a HEPA , vacuum cleaner, decontamination area, respirators, wetting equipment, and differential pressure manometer to register with the Ministry of Employment and Labor. There should be performance criteria of equipment used in asbestos removal. But there are none such criteria used in asbestos removal. This study was performed to investigate international or national performance criteria of equipment used in asbestos removal. Methods: Regulations, approved code of practice, guidance and national standards of the UK, USA and Korea were reviewed. A survey was done to investigate the requirements for equipment used in asbestos removal in Korea. Results: Air flow of NPUs used in Korea usually covers from$500m^3/h$ to over $3000m^3/h$. Some requirements for NPUs used in Korea were missing compared to the requirements of British standards for NPUs. All NPUs have different missing requirements. The UK also has separate British standard for leak tests for NPUs. Highly hazardous class vacuum cleaners should be used in asbestos removal in the UK. It has national standards on the operation of vacuum cleaners used in asbestos removal. There is only a certification system for less than 2.5kw rated voltage vacuum cleaners for home use in Korea. Powered (-assisted) respirators with mask are recommended in asbestos removal. Type 5 coveralls should be used in asbestos removal in the UK. There are international standards for requirements and leak tests of type 5 coveralls. A manometer for measuring differential pressure is needed in asbestos removal. The manometer's measuring range should cover less than ${\pm}125$ Pa and the gradation of manometer should be less than 2.5 Pa. The definition of decontamination area should be corrected. Installation of airlock and minimum area should be considered in decontamination area. Conclusions: Equipment should be used in asbestos removal proper performance and no leaks. There should be a certification system for equipment used in asbestos removal. This study can help to a certification system for equipment used in asbestos removal in Korea.

Development of Multiwire Proportional Counter for Measurement of Environmental-level Alpha Particles (환경준위 알파입자측정을 위한 다중선 비례계수기 개발(I))

  • Oh, Pil Jae;Park, Tae Soon;Lee, Min Kie;Kim, Kyung Hwa
    • Analytical Science and Technology
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    • v.9 no.3
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    • pp.262-269
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    • 1996
  • The muiltiwire proportional counter for the measurement of low-level and environmental $\alpha$ particles emitting nuclides was developed. External dimension of the devloped multiwire proportional counter is $350{\times}290{\times}30mm$ and the sensitivity area is $250{\times}200mm$. The wall material of the detector was selected the stainless steel to prevent the deformation by external impact and to obtain minimum background. The anode and cathode wires were used the stainless steel material of diameter $50{\mu}m$. The spacing of each wires are 10.0mm, 5.0mm and the numbers of total wire are 21, 42 lines, respectively. The multiwire proportional counter was designed that the measurement source is placed within the detector to prevent the wall absorption effect and the efficiency variation by various source heights. The characteristics of the developed detector have been investigated to obtain the plateau, operating voltage, background, counting efficiency, position sensitivity and energy resolution etc. For the $^{241}Am$ nuclide, the calculated LLD(Lower Limit of Detection) is 5.0mBq/L which is lower than 40mBq/L of recommended LLD value by ISO(International Organization for Standardization).

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Free Speech and the Void for Vagueness Doctrine: A Comparative Analysis of Free Speech Cases in the Korea Consitutional Court and the United States Supreme Court (표현의 자유와 "명확성 원칙": 한국 헌법재판소와 미국 연방대법원의 판례 비교연구)

  • Chang, Ho-Soon
    • Korean journal of communication and information
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    • v.55
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    • pp.5-32
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    • 2011
  • This paper is a comparative analysis of constitutional decisions in which the Korea Consitutional Court and the United States Supreme Court applied the void for vagueness doctrine into free expression issues. Common aspects are: both courts applied the void for vagueness doctrine on the grounds that vague laws bring chilling effect on freedom of expression. Acknowledging inevitable uncertainties in lawmaking and legal jargons, however, both courts required minimum standards in the void for vagueness doctrine. In the cases where unclear legal meanings resulted in constitutional challenges, both courts adopted the "narrowing construction" by the courts or judges based on average/ordinary person's understanding. The biggest differences between the two constitutional courts are their approach to the degrees of vagueness allowed in free expression cases. The U.S. Supreme Court underscored the necessity of narrowly drawn, reasonable and definite standards. Meanwhile, the Korea Constitutional Court relaxed its standards in some cases such as the National Security Law cases, even though it admitted the possibility of curtailing the right to free expression. The Court reasoned that those laws, though vague, brought with bigger social interests and are necessary tools in dealing with changing world.

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Developing Design Guidelines for Rest Area Based on the Traffic Safety (교통안전을 고려한 고속도로 휴게소 설계기준 개발)

  • Lee, Hyun-Suk;Lee, Eui-Eun;Seo, Im-Ki;Park, Je-Jin
    • International Journal of Highway Engineering
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    • v.14 no.3
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    • pp.173-182
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    • 2012
  • Entry and exits of the rest area are sections where designed speed can be rapidly change and also a weak traffic safety section. In addition, two tasks can be performed simultaneously at entry of the rest area, particularly searching for deceleration and parking spaces/parking sides etc. Thus, design criteria is required in order to procure the stability of accessed vehicle. In case of Korea, geometric structure design criteria of entry facilities, such as toll-gate, interchange, junction etc was established. However there are no presence in a detailed standards for geometric structure of the rest area which affiliated road facilities. In this study, Derive problems in regards to the entry of geometric structure of resting areas by utilizing a sight survey and an investigation research of traffic accidents. The survey was targeting 135 general service areas. After Classifying the design section of resting areas' entry as well as derive design elements on each section, a speed measurement by targeting entry of rest areas and car behavior surveys were performed, then each element's minimum standard was derived through the analyses. According to the speeds at the starting/end point of entrance connector road, the minimum length of the entrance connector road is decided as 40m using Slowing-down length formula and based on the driving pattern, the range of the junction setting angle of the entrance connector road is defined as $12^{\circ}{\sim}17^{\circ}$. Suggest improvement plans for existing rest areas that can be applied realistically. This should be corresponded to the standards of entry and exit of developed rest areas.

A Study on the Flight Safety Test of Drones for the Establishment of Toy Drone Safety Standards (완구용 드론 안전기준 재정을 위한 드론의 비행 안전성 테스트 연구)

  • Jin, Jung-Hoi;Kim, Gyou-Beom;Jin, Sae-Young
    • Journal of Convergence for Information Technology
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    • v.9 no.12
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    • pp.141-146
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    • 2019
  • Economic analysis predicts that the drone market will grow, and the growth of the toy and hobby drone market is expected to gradually expand. Drone expectations are rising due to the net economic function of drone market growth, but accidents due to improper management and operations are also increasing. The difference in toy drone performance is incomparably small compared to industrial drone performance, but the ordinary buyer can not know whether the difference can cause an accident during use. The toy drones used in this study were obtained from KC and CE certification, and 20 kinds of drones were used. The flight time ranged from a minimum of 3 minutes to a maximum of 12 minutes, and the control distance ranged from a minimum of 20m to a maximum of 380m. Therefore, it is necessary to secure product safety through sampling inspection of the radio wave output of toy drones, and it is also necessary to mount an algorithm that automatically lowers the altitude or hover when exceeding the limit flight distance. For future research, we will build data to establish toy drone safety standards through a altitude testing and impact testing of toy drone.

Research on Pilot Decision Model for the Fast-Time Simulation of UAS Operation (무인항공기 운항의 배속 시뮬레이션을 위한 조종사 의사결정 모델 연구)

  • Park, Seung-Hyun;Lee, Hyeonwoong;Lee, Hak-Tae
    • Journal of Advanced Navigation Technology
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    • v.25 no.1
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    • pp.1-7
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    • 2021
  • Detect and avoid (DAA) system, which is essential for the operation of UAS, detects intruding aircraft and offers the ranges of turn and climb/descent maneuver that are required to avoid the intruder. This paper uses detect and avoid alerting logic for unmanned systems (DAIDALUS) developed at NASA as a DAA algorithm. Since DAIDALUS offers ranges of avoidance maneuvers, the actual avoidance maneuver must be decided by the UAS pilot as well as the timing and method of returning to the original route. It can be readily used in real-time human-in-the-loop (HiTL) simulations where a human pilot is making the decision, but a pilot decision model is required in fast-time simulations that proceed without human pilot intervention. This paper proposes a pilot decision model that maneuvers the aircraft based on the DAIDALUS avoidance maneuver range. A series of tests were conducted using test vectors from radio technical commission for aeronautics (RTCA) minimum operational performance standards (MOPS). The alert levels differed by the types of encounters, but loss of well clear (LoWC) was avoided. This model will be useful in fast-time simulation of high-volume traffic involving UAS.

Study on the Establishment of the Separation Distance between Anchored Ships in Jinhae Bay Typhoon Refuge (진해만 태풍 피항지 정박 선박간 이격거리 설정에 관한 연구)

  • Won-Sik Kang;Ji-Yoon Kim;Dae-Won Kim
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.4
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    • pp.338-347
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    • 2023
  • Jinhae Bay, characterized by frequent runaway ships and strong winds during typhoon attacks, poses a high risk of maritime accidents such as ship collisions and groundings. This study aims to determine a safe separation distance between ships in the Jinhae Bay anchorage, considering the unique environmental characteristics of the Korean sea area. Analysis revealed that an average of 100-200 ships anchor in the typhoon avoidance area in Jinhae Bay during typhoon attacks, with approximately 70% of ships experiencing anchor dragging owing to strong external forces exceeding 25 m/s wind speeds. In this study, we analyzed and presented the separation distances between ships during anchoring operations based on domestic and international design standards, separation distances between ships used as actual typhoon shelters in Jinhae Bay, and appropriate safe distances for ships drifting under strong external forces. The analysis indicated that considering the minimum criteria based on the design standards and emergency response time, a minimum safe distance of approximately 400-900 m was required. In cases where ample space was available, the separation distance was recommended to be set between 700 to 900 m. The findings of this study are anticipated to contribute to the development of guidelines for establishing safe separation distances between ships seeking refuge from typhoons in Jinhae Bay in the future.