• Title/Summary/Keyword: safety standard

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Stability Evaluation of National Reference Standards for Blood Products in Korea

  • Park, Tae Jun;Choi, Chan Woong;Oh, Ho Kyung;Kim, Jae Ok;Kim, Byung Kuk;Kang, Hyun Kyung;Kwon, Eun Jeong;Gweon, Eun Jeong;Park, Sang Jin;Kang, Ho Il;Jung, Ki Kyung;Park, Sang Mi;Kim, Ji Hye;Han, Ki Won;Jeong, Ja Young
    • Toxicological Research
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    • v.33 no.3
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    • pp.225-231
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    • 2017
  • National reference standards (NRSs) for biologics are established through potency estimation by a multi-center joint study of standard materials used in the approval process for national lot release and quality control of vaccines, blood products, and other biologics. In this study, a stability evaluation was conducted to determine whether the potency of NRSs for six blood products was being maintained at a consistent level in Korea. The present study conducted real-time stability tests via in-vivo/in-vitro bioassay on NRSs for blood coagulation factor VIII concentrate (2nd standard), antithrombin concentrate, prekallikrein activator, anti-hepatitis B immunoglobulin, blood coagulation factor IX concentrate, and anti-tetanus human immunoglobulin, as well as a trend analysis using cumulative annual results. The real-time stability test results showed that the mean potency of six NRSs was all within the control limit. In the trend analysis, the potency of NRS for blood coagulation factor VIII concentrate (2nd standard) showed a decreasing trend, while the potency of all other products had been stably maintained. The present study confirmed that the mean potency of NRSs for six blood products had been stably maintained in Korea. The findings of the present study establish a foundation that can ensure the quality of NRSs for biologics in Korea, and it is expected to make a major contribution to the supply of high-quality biologics.

Slip Resistance of Contaminants on the Floor for Variation of Viscosity (점도변화에 따른 바닥 오염물질의 미끄러짐 저항 특성)

  • Park, Jae-Suk;Oh, Whan-Sup
    • Journal of the Korean Society of Safety
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    • v.27 no.5
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    • pp.185-189
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    • 2012
  • While there is no standards on slip risk for contaminants on surface, glycerol is described in standard contaminant for measuring coefficient of friction(COF) and slip resistance such as ISO 13287. But that is just used to measure the slip resistance of surface materials and shoes not to evaluate the contaminant materials. Therefore the objective of this study was to find out the relationship between standard contaminant and the contaminants used usually at the workplaces. For this, some measurement criteria were acquired from the analysis based on biomechanics and kinetics of human gait during slips. The slip resistance according to viscosity of the contaminants was measured applying the criteria and slip probability was determined by the gait analysis. Some factors which should be considered when measuring the slip resistance were identified. The velocity, acceleration, contact time and contact pressure should be 1 m/sec, 10 $m/sec^2$, 350 kPa and less than 0.5sec respectively. The variation of viscosity according to temperature for working oils was different from that of standard contaminant. The static coefficient of friction (SCOF) of working oils was almost 0.5 times as large as the SCOF of standard contaminant. So it was assumed to be difficult to compare the contaminants at the workplaces with the glycerol as a standard contaminant for estimating the slip risk.

KTX-II RAMS Application Standard for Safety of Passenger Transportation Service (안전한 고객수송서비스를 위한 KTX-II RAMS 적용기준)

  • Cha, Jae-Hwan;Chung, In-Soo;Jo, Kwang-Woo
    • Proceedings of the KSR Conference
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    • 2008.11b
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    • pp.1525-1538
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    • 2008
  • Currently, it has been a fashion to include RAMS of rolling stock in the order for purchasing the rolling stock. However, it's only to suggest a qualitative value or an ideal target without giving or demonstrating actual RAMS target, with only demonstrating passive RAMS by the data provided by the manufacturer. In the case of KTX project of 100 cars of KTX-II contracted in June 2006, their target has been suggested from the previous RAMS application standard and it aimed to achieve the reliability level of equivalent high speed rolling stock. Afterward, as actual KTX-II RAMS Plan and RAMS Demonstration Plan has been prepared and approved, it has been the first problem to secure the reliability and safety in order to introduce the new high speed rolling stock(KTX-II) successfully and we actually tried to apply overseas RAMS standard, KTX samples, electric railcar MTRC and rolling stock samples. This Report was dealt world trends of Railway RAMS standard, KTX-II RAMS Specifications, the present condition of KTX-II RAMS performance and development a way of KTX-II RAMS, We hope the "KTX-II RAMS Application Standard for Safety of Passenger Transportation Service" is served as an opportunity for the basic research for establishing and demonstrating RAMS target of components or parts composing the rolling stock system.

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Analysis on IEC 62471 for The Introduction of Photobiological Safety of LED Lamp (LED조명의 광생물학적안전성 도입을 위한 IEC 62471 규격 분석)

  • Ko, Jae-Kyu;Cho, Mee-Ryoung;Lee, Min-Jin;Kim, Ju-Hyun
    • Proceedings of the Safety Management and Science Conference
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    • 2012.11a
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    • pp.435-443
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    • 2012
  • First introduced in 1962, LED(light-emitting diodes) emitted low-intensity red light, but modern versions are now available across the ultraviolet, visible, and infrared spectrum, many with very high luminance or brightness. As a result, growing importance of potential safety harzards for human. Now when certificated of CE provide that testing through IEC/EN 62471 for any lamp. Korea standard adopted as it IEC 62471:2006, Photobiological safety of lamps and lamp systems without change, but effectiveness is incomplete. In this paper, we introduce analysis and direction that urgently come into effectiveness of KS C IEC 62471 as a national standard specifications.

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A Study on Improvement Plan on the Standard of Judgment of Electrical Code to Protect Against Electric Shock in the Water (수중감전예방을 위한 전기설비기술기준의 판단기준 개선방안 연구)

  • Kim, Han-Sang;Kim, Chong-Min
    • Journal of the Korean Society of Safety
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    • v.21 no.6 s.78
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    • pp.33-37
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    • 2006
  • Underwater lighting is installed in water tanks, fountains and pools in waterparks, it has direct contact with water and in case of any electrical failure due to faults from electrical equipment, there is a lot of electrical shock risk. In this paper, we proposed an improvement plan of the standard of judgment of electrical code which is MOCIE (Ministry of Commerce, Industry and Energy) notification by fact finding survey and analysis of the domestic and foreign codes.

A Study on Development of Standard Safety Operation Method Risk Analysis by Weight (가중치 적용에 의한 표준안전 작업방법 위험성평가 개발에 관한 연구)

  • Yang, Kwang-Mo
    • Journal of the Korea Safety Management & Science
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    • v.9 no.1
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    • pp.23-35
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    • 2007
  • Present time there are many risk analysis method in the world. A hazard is an exposure that has the potential to induce and adverse event. Risk is the probability of an adverse event given exposure to hazard. The evaluation of scientific information on the hazardous properties of environmental agents and the extent of exposure to these agents. But operation risk analysis method is not enough for manufacturing industry even if it is existence, it will be separated to improve Safety. In this paper, I will develop the AHP Weighted operation risk analysis method to improve Safety.

A study on the fire safety evaluation of the urban rail vehicle (Fire characteristic evaluation of interiors) (도시철도차량 화재안전도 평가에 대한연구(I) (내장재 화재특성 평가 중심으로))

  • Jung, Woo-Sung;Lee, Duck-Hee;Lee, Cheul-Kyu;Lee, Ju-Bong
    • Proceedings of the KSR Conference
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    • 2006.11b
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    • pp.202-206
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    • 2006
  • Although the urban rail vehicle is exposed to the fire disaster, most country, except only a few advanced country, is insufficient to take a measure against the fire accident. Safety regulation modification, fire safety standard of the materials. and each material's fire resistance of the rail vehicle have been upgraded until the Daegu fire disaster in Korea. For that reason, In this study, current techniques of fire safety evaluation are analyzed and fire safety degrees of rail vehicles are compared with the change of interiors which is met to the fire safety standard of urban rail vehicle.

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Development of a Supporting Program for the Emergency Preparedness Plan (사고대비물질 취급자의 비상대응계획 작성 프로그램 연구)

  • Kim, Sung-Bum;Noh, Hye-Ran;Seok, Gwang-Seol;Park, Jae-Deuk
    • Journal of the Korean Society of Safety
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    • v.26 no.5
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    • pp.54-58
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    • 2011
  • Emergency preparedness plan(EPP) is the systematic management of activities that involve a material degree of risk of loss or other damage to the surroundings(people, property and environment), and the boundary of accident recovery plan(ARP). The main purpose of the program is to provide a safety management system to each facility in order to enable to prevent accident and to control accident immediately. The EPP includes not only typical safety-related documentations such as material safety data sheet(MSDS), standard operation procedure(SOP), emergency response plan(ERP). EPP is established basis of the preliminary safety analysis involving risk identification, assessment and prevention plans. The program is also helpful for government or related agencies to control a number of accidents in small-scale companies in the whole country.

Development and Calibration of a Plate Type Eddy Current Standard (평판형 와전류 표준 시험편의 개발 및 교정)

  • Kim, Young-Joo;Kim, Young-Gil;Ahn, Bong-Young;Yoon, Dong-Jin
    • Journal of the Korean Society for Nondestructive Testing
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    • v.27 no.5
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    • pp.393-397
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    • 2007
  • Eddy current standard including an artificial slot for the calibration of absolute type surface probe was fabricated. Developed eddy current standard has the electric conductivity and dimensions, and contains artificial slot as established in ASTM E 1629. The width and depth of artificial slot are 0.1 mm and 0.5 mm respectively. This slot was only possible to measure the depth on the two side edges, and impossible for the middle part with general measurement tools. The ultrasonic test method was applied for measuring depth of the middle part of the artificial slot in the standard. Using this method the dimension could be measured successfully with uncertainty about $15\;{\mu}m$. Calibration of eddy current standard for the absolute probe can be performed by this technique.

Factors Influencing Nursing Students' Performance of Standard Precaution for Healthcare-Associated Infection Control (간호대학생의 의료관련감염관리를 위한 표준주의 수행도에 미치는 영향요인)

  • Yoon, Eun-Joo;Park, Young-Mi
    • Journal of Convergence for Information Technology
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    • v.8 no.5
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    • pp.19-27
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    • 2018
  • The goal of this study was to survey the degree of nursing students' knowledge of standard precaution, intention about performance, attitude toward performance, safety climate, performance of standard precaution and to identify factors influencing performance. A cross-sectional survey was implemented with samples of 296 nursing students. We collected the data from June 15 to 30, 2018 and analyzed by SPSS 21.0 program. There were significant correlation between intention about performance, attitude toward performance, safety climate and performance. The factors that affecting performance of standard precaution among nursing students are intention about performance and safety climate, which explained 20% of the variances. Therefore, It needs to develop an infection management education program and to prepare an safe nursing practice environments in hospitals for nursing students to improve their implementation of standard precautions for preventing clinical infection.