• 제목/요약/키워드: Biological Hazard Analysis

검색결과 68건 처리시간 0.02초

의료용 표시기의 안전성 및 성능 평가를 위한 시험 항목 및 시험방법(안)연구 (Development of Standards of Tattoo Machine for Safety and Performance Evaluation)

  • 김영균;조승관;이태우;여창민;정병조;권영미;차지훈;허찬희;박기정;김동섭;김한성
    • 대한의용생체공학회:의공학회지
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    • 제32권2호
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    • pp.151-157
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    • 2011
  • Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

가축분뇨 유래 퇴비 및 농경지 중 축산용 항생제의 잔류 및 위해성 평가 (Residue and risk assessment of veterinary antibiotics in manure-based composts and agricultural soils)

  • 백민경;류송희;김성철;홍영규;김진욱;김정규;권오경
    • Journal of Applied Biological Chemistry
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    • 제64권2호
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    • pp.177-184
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    • 2021
  • 축산용 항생제는 투여된 양의 일부만이 체내에서 사용되며 나머지는 분뇨로 배출되며 이를 활용한 퇴비를 농경지에 살포함으로써 농업환경에 유입되어 2차 오염 등을 초래하고 있다. 따라서, 농업환경 중 항생제 관리기준 설정 등 사후 관리 기술이 필요하다. 본 연구는 국내 사용빈도가 높은 것으로 알려진 tetracycline 및 sulfonamide 계열 등의 항생제를 대상으로 매체별 잔류량을 비교하고 퇴비 시용 전·후 농경지 토양 중 잔류항생제의 위해성을 평가하기 위하여 수행되었다. Buffer 및 SPE를 사용한 전처리 방법은 ppb 수준에서 70% 이상의 회수율을 나타냈으며, 검출한계(LOD)의 범위는 퇴비와 토양에서 각각 0.13-0.46 ㎍/kg과 0.05-0.25 ㎍/kg이었다. 잔류 항생제 분석결과 퇴비 중 tetracycline 계열 항생제의 잔류 농도는 5.38-196.0 ㎍/kg, sulfonamide 계열은 below the detection of limit (BDL)-259.0 ㎍/kg 수준으로 검출되었다. 농경지 토양의 경우 각각 0.30-53.3 ㎍/kg, BDL-4.16 ㎍/kg의 잔류 수준을 나타냈으며 토양분배계수(Kd) 값이 높은 tetracycline 계열 항생제의 잔류 농도가 sulfonamide 계열보다 높았다. 퇴비 시용 전후의 농경지 토양의 항생제에 대한 인체위해도는 항생제 종류에 따른 차이가 있었으나, 전체 HQ가 1 이하에서 안전하다는 기준에 의하면 조사된 항생제 5종 모두 인체 위해성이 매우 낮았으며 시용 전·후의 영향이 전체 위해도에 미치는 비율을 고려하면, 퇴비시용이 토양의 항생제에 대한 인체위해성에 미치는 영향은 미비한 것으로 판단되었다.

Evaluation of Chromosomal Alteration in Electrical Workers Occupationally Exposed to Low Frequency of Electro Magnetic Field (EMFs) in Coimbatore Population, India

  • Balamuralikrishnan, Balasubramanian;Balachandar, Vellingiri;Kumar, Shanmugam Suresh;Stalin, Nattan;Varsha, Prakash;Devi, Subramaniam Mohana;Arun, Meyyazhagan;Manikantan, Pappuswamy;Venkatesan, Chinnakulandhai;Sasikala, Keshavarao;Dharwadkar, Shahnaz N.
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권6호
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    • pp.2961-2966
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    • 2012
  • Extremely low frequency electro magnetic fields (EMFs) have been classified as possibly carcinogenic to humans by the International Agency for Research on Cancer. An increased number of chromosomal alterations in peripheral lymphocytes are correlated with elevated incidence of cancer. The aim of the present study was to assess occupationally induced chromosomal damage in EMF workers exposed to low levels of radiation. We used conventional metaphase chromosome aberration (CA) analysis and the micronucleus (MN) assay as biological indicators of non ionizing radiation exposure. In the present study totally 70 subjects were selected including 50 exposed and 20 controls. Informed written consent was obtained from all participants and the study was performed in accordance with the Declaration of Helsinki and the approval of the local ethical committee. A higher degree of CA and MN was observed in exposed subjects compared to controls, the frequency of CA being significantly enhanced with long years of exposure (P<0.05). Moreover increase in CA and MN with age was noted in both exposed subjects and controls, but was significantly greater in the former. The results of this study demonstrated that a significant induction of cytogenetic damage in peripheral lymphocytes of workers occupationally exposed to EMFs in electric transformer and distribution stations. In conclusion, our findings suggest that EMFs possess genotoxic capability, as measured by CA and MN assays; CA analysis appeared more sensitive than other cytogenetic end-points. It can be concluded that chronic occupational exposure to EMFs may lead to an increased risk of genetic damage among electrical workers.

Identification of Homer1 as a Potential Prognostic Marker for Intrahepatic Cholangiocarcinoma

  • Wu, San-Yun;Yu, Ming-Xia;Li, Xiao-Gai;Xu, Shu-Fang;Shen, Ji;Sun, Zhen;Zhou, Xin;Chen, Xing-Zhen;Tu, Jian-Cheng
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권7호
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    • pp.3299-3304
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    • 2014
  • Background: The aim of the present study was to analyze whether Homer1 is a potential prognostic marker for intrahepatic cholangiocarcinoma (ICC). Materials and Methods: The expression of Homer1 in ICC tissue was detected with immunohistochemistry and levels of protein in ICC and paratumor tissues were evaluated by Western blotting. Survival analysis by the Kaplan-Meier method was performed to assess prognostic significance. Results: Homer1 expression was high in 67.4% (58/86) of ICC samples, and there was significant difference between ICC and adjacent noncancerous tissues (p<0.001); high expression was associated with poor histologic differentiation (p=0.019), TNM stage (p=0.014), lymph node metastasis (p=0.040), and lymphatic invasion (p=0.025). On Kaplan-Meier analysis, a comparison of survival curves of low versus high expressors of Homer1 revealed a highly significant difference in OS (p=0.001) and DFS (p=0.006), indicating that high expression of Homer1 was linked with a worse prognosis. Multivariate analyses showed that Homer1 expression was an independent risk factor predicting overall survival[Hazard ratio(HR), 7.52; 95% confidence interval (CI), 2.63-21.47; p=0.002] and disease-free survival (HR, 11.56; 95%CI, 5.17-25.96; p<0.001) in ICC. Conclusions: Homer1 promotes lymphatic invasion and associates with lymph node metastasis and poor prognosis of ICC. The current study shows that Homer1 may be an independent prognostic factor for ICC patients after curative resection, and it provides an important basis for screening/treating high-risk patients.

위험평가모형($TrophicTrace^{(R)}$)을 이용한 가상 해양오염퇴적물의 쥐노래미와 인체 영향 예비평가 (Potential Human Health and Fish Risks Associated with Hypothetical Contaminated Sediments Using a Risk Assessment Model ($TrophicTrace^{(R)}$))

  • 양동범;홍기훈;김경련
    • 대한환경공학회지
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    • 제33권1호
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    • pp.60-70
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    • 2011
  • 본고에서는 현재 시행중인 해양오염퇴적물질 관리용 유해화학물질 정화지수($CI_{HC}$)를 대상으로, $CI_{HC}$은 동일하나 유해 물질별 함량이 다른 해저퇴적물들이 같은 생물위험을 보이는가를 판단하려 하였다. 이를 위해 5개의 가상 오염퇴적물을 설정하고, 퇴적물 위험평가를 위한 트로픽트레이스 모형($TrophicTrace^{(R)}$ model)을 이용하여, 이 가상 퇴적물이 쥐노래미(Hexagrammos otakii)에 대해 미치는 생물위험을 최대무작용량에 기반한 독성지수(NOAEL TQ)와 최소작용량에 기반한 독성지수(LOAEL TQ)로 평가하였다. 쥐노래미에 대한 NOAEL TQ의 합계는 5개 가상 오염퇴적물에서 0.69~1.54의 범위였고, LOAEL TQ의 합계는 0.111~0.261로 약 2배 이상의 차이가 났다. 이는 퇴적물 유해물질 환경기준이 해양저서무척추동물군집에 대한 영향만을 고려하고 사람으로 연결되는 식용의 쥐노래미에 대한 영향을 반영하지 않기 때문으로 사료된다. 인체에 대한 비발암위험지수(HI) 값은 PCB의 경우 9.8~47.1로 매우 위험한 것으로 나타났다. PCB의 발암위험도는 5개 퇴적물에서 $39{\sim}190{\times}10^{-5}$으로 높게 나타났으며 As의 경우에도 $8.1{\sim}18.0{\times}10^{-5}$으로 높게 나타났다. 유해화학물질정화지수가 8로 동일한 5개 가상 오염퇴적물에서 비발암위험지수(HI) 및 발암위험도가 서로 매우 다르게 나타난 것은 각 오염물질별로 인체에 악영향을 미치는 정도가 다르기 때문이다.

대학 실험실에서의 유기화합물 노출에 의한 건강위험성 평가에 관한 연구 (A Study on Health Risk Assessment by Exposure to Organic Compounds in University Laboratory)

  • 심상효;원정일;전하섭;김도원
    • 한국학교ㆍ지역보건교육학회지
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    • 제22권4호
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    • pp.49-60
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    • 2021
  • Objectives: Laboratories have various latent physical, chemical, biological, and ergonomical factors according to the diversification and fusion of research and development activities. This study aims to investigate the chemical exposure concentrations of college laboratories and evaluate their health risks, and use them as basic data to promote the health of college students. Methods: The sampling and analysis of harmful chemicals in the air in laboratories were performed using Method 1500 of the U.S. National Institute for Occupational Safety and Health (NIOSH)의 Method 1500. The harmful chemicals in the laboratories were divided into carcinogenic and non-carcinogenic chemicals. Risk assessment was performed using the cancer risk (CR) for carcinogenic chemicals and using the hazard index (HI) for non-carcinogenic chemicals. Results: The harmful chemicals in college laboratories consisted of acetone, diethyl ether, methylene chloride, n-hexane, ethyl acetate, chloroform, tetrahydrofuran, toluene, and xylenes. They showed the highest concentrations in laboratories A (acetone 0.001~2.34ppm), B (chloroform 0.95~6.35ppm), C (diethyl ether 0.08~8.68ppm), and D (acetone 0.07~14.96ppm). The risk assessment result for non-carcinogenic chemicals showed that the HI of methylene chloride was 2.052 for men and 2.333 for women, the HI of N-hexane was 4.442 for men and 5.05 for women. Thus, the HI values were higher than 1. The risk of carcinogenic chemicals is determined by an excess cancer risk (ECR) value of 1.0×10-5, which means that one in 100,000 people has a cancer risk. The ECRs of chloroform exceeded 1.0×10-5 for both men and women, indicating the possibility of cancer risk. Conclusion: College laboratories showed the possibility of non-carcinogenic health risks for methylene chloride, n-hexane, tetrahydrofuran (THF), toluene, and xylenes, and carcinogenic health risks for chloroform, methylene chloride. However, this study used the maximum values of measurements to determine the worst case, and assumed that the subjects were exposed to the corresponding concentrations continuously for 8 hours per day for 300 days per year. In consideration of the nature of laboratory environment in which people are intermittently exposed, rather than continuously, to the chemicals, the results of this study has an element of overestimation.

사용적합성 평가를 적용한 국산 범용인공호흡기의 위험요인 분석 (Analysis of Hazard Factors for Domestic General Purpose Ventilator using Usability Assessment)

  • 권경민;김승희;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제45권1호
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    • pp.10-19
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    • 2024
  • The purpose of this study is to conduct a summative evaluation of the usability of a general-purpose ventilator to determine whether it can be used for its intended purpose in the intended environment by the intended user and to find possible errors in use. The importance of ventilators has increased due to the accelerated aging of the population and the impact of the pandemic. In addition, patients who require ventilators are often in critical condition, so even a small error in use can be fatal. Therefore, it is important to ensure that the ventilator has sufficient stability and can be used satisfactorily without inconvenience to the user. In this study, we conducted a usability test with 17 respiratory nurses with more than 3 years of experience using the ventilator. We analyzed the task success rate, satisfaction, and opinions of the intended users while going through a total of 17 scenarios. Satisfaction was captured through an ASQ questionnaire and subjective opinions were captured through a detailed opinion questionnaire. The results showed a high level of satisfaction with an average score of 6.3 for the use scenarios. Evaluators expressed satisfaction with the overall visibility and versatility of the features, but noted that improvements were needed for calibration tasks with low task success rates. As the calibration method is different from other equipment, it was suggested that specific explanations of the calibration method and the picture that appears when calibrating are needed, and that if relevant training is provided, the equipment can be used without problems. If the usability evaluation is not limited to securing efficiency and satisfaction from the intended users, but also continuously receives feedback from users to prepare for use in emergency environments such as pandemic situations, it will be very helpful to seize opportunities such as emergency authorization in future situations, and ultimately contribute to patient safety by reducing use errors.

GAP 모델 확립을 위한 토마토 농장 수확단계의 위해요소 조사 및 분석 (Risk Analysis for the Harvesting Stage of Tomato Farms to Establish the Good Agriculture Practices(GAP))

  • 이채원;이치엽;허록원;김경열;심원보;심상인;정덕화
    • 농업생명과학연구
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    • 제46권4호
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    • pp.141-153
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    • 2012
  • 본 연구에서는 안전한 토마토를 생산하기 위한 농산물우수관리제도(Good Agriculture Practices; GAP) 모델 확립의 기초 자료를 제공하고자 경남에 소재한 토마토 재배 농가 중 토경 재배 3 농가와 양액 재배 3 농가를 대상으로 수확단계에서의 생물학적(위생지표세균, 병원성 미생물, 곰팡이), 화학적(중금속, 농약) 및 물리적 위해요소를 조사하였다. 먼저 생물학적 위해요소 분석결과, 일반세균과 대장균군은 토경재배 농장의 토양에서 최대 7.5 및 5.0 log CFU/g으로 양액재배 농장의 양액보다 0.1~2.8 log CFU/g 높은 수준으로 검출되었다. 그 외 다른 시료에서의 일반세균 및 대장균군의 경우 토경재배 농장에서는 1.7~6.5 및 0.3~2.9 log CFU/g, leaf, mL, hand or $100cm^2$로 검출되었고 양액재배 농장에서는 각각 1.1~5.7 및 0.1~4.0 log CFU/g, leaf, mL, hand or $100cm^2$로 검출되었다. 대장균은 모든 시료에서 검출되지 않았으며, 곰팡이의 경우 전체적으로 0.2~5.0 log CFU/g, leaf, mL, hand or $100cm^2$ 수준으로 검출되었다. 병원성 미생물은 Bacillus cereus와 Staphylococcus aureus만 양액을 제외한 대부분의 시료에서 검출되었으며, 공중낙하균은 토경재배 농장에서 0.4~1.6 log CFU/plate, 양액재배 농장에서 0.1~1.0 log CFU/plate 수준으로 검출되었다. 화학적 위해요소인 중금속(Cd, Pb, Cu, Cr, Hg, Zn, Ni 및 As)과 잔류농약은 모든 시료에서 국내 허용기준치 이하로 검출되었고, 물리적 위해요소는 다른 위해요소에 비해 발생가능성은 낮지만 유리조각, 캔 등으로 확인되었다.