• Title/Summary/Keyword: food risk

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Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0 (IEC 60601-1: 3판이 적용된 진단용 X선장치 관련 개별규격의 동향 및 특징)

  • Kim, Hyun-Ji;Kim, Jung-Min;Choi, In-Seok;Yoon, Yong-Su;Seo, Deok-Nam;Kim, Jung-Su;Kim, Dae-Young;Park, Sung-Yong
    • Journal of radiological science and technology
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    • v.36 no.1
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    • pp.1-10
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    • 2013
  • IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.

Bacteriological and Physiochemical Quality of Seawater and Surface Sediments in Sacheon Bay (사천만의 해수 및 표층 퇴적물의 세균학적 및 이화학적 특성)

  • Park, Jun-Yong;Kim, Yeong-In;Bae, Ki-Sung;Oh, Kwang-Soo;Choi, Jong-Duck
    • Journal of agriculture & life science
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    • v.44 no.2
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    • pp.7-15
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    • 2010
  • This study was conducted to investigate the bacteriological and physiological quality of seawater and surface sediments in Sacheon Bay of Korea from January to September in 2009. During the study period, the means of temperature was range from 5.3 to $24.9^{\circ}C$ (mean $17.7{\pm}0.4^{\circ}C$), transparency range from 1.4 to 2.5 m (mean $1.8{\pm}0.5m$), suspended solid ranged from 16.2 to 35.8 mg/L (mean $24.2{\pm}2.2mg/L$), chemical oxygen demand ranged from 1.42 to $3.29mgO_2/L$ (mean $2.06{\pm}0.55mgO_2/L$), dissolved oxygen ranged from 6.7 to 9.5mg/L (mean $7.9{\pm}0.6mg/L$), respectively. Seafood, if eaten raw, carries the risk of food poisoning. Seafood poisoning is often cause by pathogenic microorganism originating from fecal contamination, such as Salmonella sp., Shigella sp. and norovirus. Fecal coliforms are an important indicator of fecal contamination. Therefor, data on fecal coliform are very important for evaluating the safety of fisheries in coastal areas. So, we investigated the sanitary indicate bacteria. In this study, 56 sea water samples were collected from the Sacheon Bay, and total and fecal coliforms were compared and analyzed. The coliform group and fecal coliform MPN's of sea water in Sacehon Bay were ranged from <1.8~7,900 MPN/100mL (GM 214.7 MPN/100mL) and <1.8~330 MPN/100mL (GM 9.7 MPN/ 100mL), respectively. Total coliforms were detected in 75.0% of the samples and 76.2% of the total coliforms were fecal coliforms. During the study period, the means of water content, ignition loss, COD, and acid volatile sulfates in sediments in Sacheon Bay were $53.28{\pm}2.58%$, $9.38{\pm}0.42%$, $14.23{\pm}3.36mgO_2/g$, $0.09{\pm}0.07mgS/g$, respectively.

Mediation analysis of dietary habits, nutrient intakes, daily life in the relationship between working hours of Korean shift workers and metabolic syndrome : the sixth (2013 ~ 2015) Korea National Health and Nutrition Examination Survey (교대근무자의 근무시간과 대사증후군의 관계에서 식습관, 영양섭취상태, 일상생활의 매개효과 분석 : 6기 국민건강영양조사 (2013 ~ 2015) 데이터 이용)

  • Kim, Yoona;Kim, Hyeon Hee;Lim, Dong Hoon
    • Journal of Nutrition and Health
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    • v.51 no.6
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    • pp.567-579
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    • 2018
  • Purpose: This study examined the mediation effects of dietary habits, nutrient intake, daily life in the relationship between the working hours of Korean shift workers and metabolic syndrome. Methods: Data were collected from the sixth (2013-2015) Korea National Health and Nutrition Examination Survey (KNHANES). The stochastic regression imputation was used to fill missing data. Statistical analysis was performed in Korean shift workers with metabolic syndrome using the SPSS 24 program for Windows and a structural equation model (SEM) using an analysis of moment structure (AMOS) 21.0 package. Results: The model fitted the data well in terms of the goodness of fit index (GFI) = 0.939, root mean square error of approximation (RMSEA) = 0.025, normed fit index (NFI) = 0.917, Tucker-Lewis index (TLI) = 0.984, comparative fit index (CFI) = 0.987, and adjusted goodness of fit index (AGFI) = 0.915. Specific mediation effect of dietary habits (p = 0.023) was statistically significant in the impact of the working hours of shift workers on nutrient intake, and specific mediation effect of daily life (p = 0.019) was statistically significant in the impact of the working hours of shift workers on metabolic syndrome. On the other hand, the dietary habits, nutrient intake and daily life had no significant multiple mediator effects on the working hours of shift workers with metabolic syndrome. Conclusion: The appropriate model suggests that working hours have direct effect on the daily life, which has the mediation effect on the risk of metabolic syndrome in shift workers.

"The U.S. military uses ginseng?": The official entrance of ginseng to the U.S. dietary supplement market and the U. S. military's dietary supplement manual in the late 20th century ("미군의 인삼 복용?" : 20세기 말 인삼의 미국 식이보충제 시장 편입과 미군 매뉴얼)

  • Seok, Yeong-dal
    • Journal of Ginseng Culture
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    • v.1
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    • pp.93-109
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    • 2019
  • This study aims to look at the process of ginseng being removed from the Western pharmacopoeia in the 19th century, experiencing a crisis as an export product in the America in the 20th century, and eventually settling in the U.S. society and the military as a dietary supplement in the 21th century. In this process, the legislation of provided a bridgehead for ginseng and other botanical dietary supplements to enter the U.S. market. As a result, ginseng could be re-listed in the U.S. pharmacopoeia as a dietary supplement. However, this did not mean a complete soft landing of ginseng and other botanical dietary supplements in the America. The U.S. medical community, which has been afraid of the indiscriminate spread of botanical dietary supplements, has constantly raised "the risk-discourse" and expressed concerns over the use and abuse of botanical dietary supplements that have not been scientifically verified. This involved not only the fundamental problems caused by the lax verification process of , but also a new atmosphere in the U.S. where the public sought information about botanical dietary supplements rather than seeking professional clinicians related to their health. Against this situation, "the advocate-discourse" suggested by dietary supplement manufacturers and the people in charge of botanical products seemed rather relaxed. As consumers are taking this side, the advocates had only to stress that botanical dietary supplements have been used worldwide for a long time without any problems and were made from 'natural' materials. The fact that ginseng and other botanical dietary supplements were able to advance to the U.S. Military's dietary supplement manual, which is strict in controlling food, seems to have jumped on the bandwagon of this atmosphere in the U.S. Society. In the early U.S. dietary supplement manual reviewed in this paper, ginseng was the most detailed among many botanical dietary supplements. Although there are some 'safety concerns' that still exist in the civilian society, but there are also certainly good scientific explanations for the efficacy and references to the popularity and influence of ginseng in the American society. Given this, the U.S. society and military's interest in ginseng as a dietary supplement seem quite high.

Effect of Scytosiphon lomentaria Ethanol Extracts on Myostatin Activity and Zebrafish Obesity Induced by High Feeding (고리매(Scytosiphon lomentaria) 에탄올 추출물이 마이오스타틴 활성과 고 급식으로 유도된 비만 제브라피쉬에 미치는 영향)

  • Jung, Jun Gyo;Kim, Jae Hong;Kim, Jeong Hwan;Kim, Yong Soo;Jin, Deuk-Hee;Jin, Hyung-Joo
    • Journal of Life Science
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    • v.31 no.8
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    • pp.699-709
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    • 2021
  • Muscle mass improvement through lifestyle modification has been shown to reduce the risk of metabolic syndrome. This study examined the capacity of ethanol extracts of Scytosiphon lomentaria (SLE) to suppress the bioactivity of myostatin, a potent negative regulator of skeletal muscle mass, as well as the effect of SLE treatment on metabolic homeostasis in obese zebrafish induced by high feeding. A total of 10 ㎍/ml SLE completely blocked myostatin (1 nM/ml) signaling in the pGL3-(CAGA)12 luciferase assay and suppressed myostatin-induced Smad2 phosphorylation in the Western blot analysis. In the zebrafish larvae analysis, the whole body glucose concentration of the high feeding control (HFC) group was significantly higher than that of the normal feeding control (NFC) group. However, the glucose levels of the high feeding group treated with 12.5 ug SLE and of the high feeding group treated with 18.75 ug SLE were similar to those of the NFC group. The mRNA expression level of the GLUT2 gene of the HFC group was significantly lower than that of the NFC group. SLE treatment restored the expression of the GLUT2 gene to a level that was close to that of the NFC group, indicating that SLE is capable of regulating glucose levels in zebrafish larvae. The current results highlight the potential of SLE as a natural MSTN inhibitor and supplement that can be used to facilitate the treatment of metabolic syndrome.

Ethanol Extract of Glycyrrhiza uralensis Protects Against Oxidative Stress-induced DNA Damage and Apoptosis in Retinal Pigment Epithelial Cells (망막색소상피세포에서 감초 추출물의 산화적 스트레스에 의한 DNA 손상 및 apoptosis 유발의 차단 효과)

  • Kim, So Young;Kim, Jeong-Hwan;Kim, Sung Ok;Park, Seh-Kwang;Jeong, Ji-Won;Kim, Mi-Young;Lee, Hyesook;Cheong, JaeHun;Choi, Yung Hyun
    • Journal of Life Science
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    • v.29 no.11
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    • pp.1273-1280
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    • 2019
  • Age-related macular degeneration (AMD) is one of the leading causes of blindness in the elderly population, and damage to retinal pigment epithelial (RPE) cells due to oxidative stress contributes to the development of AMD. Glycyrrhiza uralensis Fischer is one of the most widely used herbal medicines for the treatment of various diseases in Asian countries. Although recent studies indicated that treatment with G. uralensis can protect cells from oxidative stress, its mechanisms in RPE cells remain unknown. We evaluated the effect of a G. uralensis ethanol extract (GU) on $H_2O_2$-induced oxidative injury in ARPE-19 RPE cells. The GU pretreatment attenuated reactive oxygen species (ROS) generation induced by $H_2O_2$, which was associated with induced expression of nuclear factor erythroid-derived-2-like 2 (Nrf2) and heme oxygenase-1 (HO-1). GU also suppressed $H_2O_2$-induced DNA damage and mitochondrial dysfunction. The inhibitory effect of GU on $H_2O_2$-induced apoptosis was associated with the protection of caspase-3 activation. Overall, GU appeared to protect RPE cells from oxidative injury by inhibiting DNA damage and reducing apoptosis. Further studies are needed to determine the regulation of Nrf2-mediated HO-1 expression, but our results suggest the possibility of using GU to reduce the risk of AMD.

Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.209-244
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    • 2020
  • TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

The Three Types of Clinical Manifestation of Cow's Milk Allergy with Predominantly Intestinal Symptoms (위장관 증세 위주로 발현하는 영유아기 우유 알레르기 질환의 3가지 임상 유형에 관한 고찰)

  • Lee, Jeong-Jin;Lee, Eun-Joo;Kim, Hyun-Hee;Choi, Eun-Jin;Hwang, Jin-Bok;Han, Chang-Ho;Chung, Hai-Lee;Kwon, Young-Dae;Kim, Yong-Jin
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.3 no.1
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    • pp.30-40
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    • 2000
  • Purpose: During the first year of life, cow's milk protein is the major offender causing food allergy. Cow's milk allergy (CMA) affects 2~7% of infants, of which approximately one-half show predominantly gastrointestinal symptoms. We studied the clinical types of cow's milk allergy with predominantly gastrointestinal symptoms (CMA-GI) of childhood. Methods: The retrospective study was performed on 30 (male 22, female 8) patients who had diagnosed as CMA-GI during 2 years and 3 months from March 1995 to June 1997. Results: 1) Children with CMA-GI presented in the three types of clinical manifestation on the basis of time to reaction to milk ingestion: Quick (Q) onset (5 cases), Slow (S) onset (20 cases), Quick & Slow (Q&S) (5 cases). 2) Age on admission of the three groups was significantly different (p<0.05): (Q onset: $81.4{\pm}67.1$ days, S onset: $31.9{\pm}12.7$ days, Q&S: $366.0{\pm}65.0$ days). Although the body weight at birth was 10~95 percentile in all patients, body weight on admission was different: (Q onset: 10~50 percentile, S onset: below 10 percentile, Q&S: 10~25 percentile). S onset group was significantly different compared with other groups (p<0.05) and 90% of this one was failure to thrive below 3 percentile. 3) Peripheral leukocyte counts were as followings: (Q onset: $5,700{\sim}12,300/mm^3$, S onset: $10,000{\sim}33,400/mm^3$, Q&S: $5,200{\sim}14,900/mm^3$). Slow onset group was significantly different compared with other groups (p<0.05). Serum albumin levels on admission were as followings: (Q onset: $4.2{\pm}0.4\;g/dl$, S onset: $3.0{\pm}0.3\;g/dl$, Q&S: $4.0{\pm}0.3\;g/dl$). S onset group was significantly different compared with other groups (p<0.05) and 85% of this one was below 3.5 g/dl. 4) Although morphometrical analysis on small intestinal mucosa did not show enteropathy in Q onset and Q&S groups, all cases of S onset revealed enteropathy: 45% of this one showed subtotal villous atrophy, 55 % showed partial villous atrophy. 5) Allergic reaction test to other foods was not performed in S onset group because of ethical problem and high risk in general condition. In Q onset group, allergic reaction to one or two other foods: soy formula, weaning formula and eggs. Q&S goup revealed allergic reactions to several foods or to most of all foods except protein hydrolysate formula: eggs, potatos, some kinds of sea food, apples, carrots, beef and chicken. 6) Serum IgE level, peripheral eosinophil counts, milk RAST, soy RAST, skin test were not significantly different among groups. Conclusion: CMA-GI may present in three clinical ways on the basis of time to reaction to milk ingestion, typical clinical findings and morphologic changes in the small bowel mucosal biopsy specimens. This clinical subdivision might be helpful in diagnostic and therapeutic approaches in CMA-GI. Early suspicion is mandatory especially in S onset type because of high risks with malnutrition and enteropathy.

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A Study on Serum Lipid Levels in Elderly People in Wando Area - Based on Age, BMI, WHR - (완도지역 성인 및 노인의 혈청지질 수준에 관한 연구(I) - 연령, 신체 계측치를 중심으로 -)

  • Cha, Bok-Kyeong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.1
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    • pp.68-77
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    • 2006
  • This study was peformed to document the association between nutrient intakes, body mass index (BMI), waist/hip ratio (WHR), and a major risk factor for chronic diseases. A three-day dietary intake survey, using a 24 hour recall method, was obtained from 187 subjects aged 46 to 84 (mean age 65.3) living in Wando island area. The average daily mean energy intakes were 1869.0 kcal for male and 1943.9 kcal for female, respectively. Daily intakes of protein for male and female were 28.0 and 30.4 g, and those of fat were 31.5 and 28.51 g, respectively Carbohydrate dependency was decreased with age. Protein dependency was increased with age. The mean intakes of energy, protein, Vit. A, Vit. D, Vit. E, Ca, Zn did not meet Korean RDA for elderly. The level of serum triglyceride was higher in males than in females and showed the tendency to increase with age in both sexes, whereas HDL-cholesterol tended to decrease with age in both sexes. The levels of serum total-cholesterol and LDL-cholesterol were significantly higher in males than in females, particularly in the age of $46\~59$ (p<0.05). The level of atherogenic index (AI) was significantly higher in females than in males, particularly in the age of 80 and over (p<0.05) Based on these results, it is evident that people in island area did not consume enough nutrient. Specially, dietary intake of protein was not adequate. This study implies that triglyceride, total-cholesterol, LDL-cholesterol, AI were increased with increasing age, BMI and WHR.

A Study on Serum Lipid Levels of Elderly People in Wando Area -Based on Dietary Behaviors- (완도지역 중·장년층의 혈중지질 수준에 관한 연구 -식행동을 중심으로-)

  • Kim, Eun-Ju;Cha, Bok-Kyeong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.9
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    • pp.1148-1160
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    • 2007
  • This study was performed to document the association between eating behaviors and major risk factors for cardiovascular diseases. Those who stated that they ate a daily breakfast for male and female were 88.6% and 96.0%, $1{\sim}2$ times a week were 9.1% and 2.0%, $3{\sim}4$ times a week were 2.3% and 2.0%, respectively. Those who stated that they were overeating of $0{\sim}1$ time a week for man and female were 80.7% and 89.9%, overeating of $2{\sim}3$ times a week were 19.3% and 10.1%, respectively. Those who said that they were regular of meal time for man and female were 38.6%, and 37.4%, sometimes irregular of meal time were 14.8% and 19.2%, irregular of meal time were 46.6% and 43.4%, respectively. Those who said that they were light of eating volume for man and female were 20.5% and 25.3%, moderate of eating volume were 69.3% and 61.6%, heavy of eating volume were 10.2% and 13.1%, respectively. Those who said that they were very fast of eating speed for man and female were 15.9% and 8.1%, fast of eating speed were 51.1% and 34.3%, moderate of eating speed were 4.5% and 20.2%, slow of eating speed were 17.0% and 14.1%, and very slow of eating speed were 11.4% and 23.2%, respectively. Higher frequency of breakfast a week resulted in higher serum total cholesterol and blood sugar for the daily eating group for both genders with women having high LDL-cholesterol and HDL-cholesterol. Both group had high HDL-cholesterol and low blood sugar with less number of overeating, with men having low triglyceride and LDL-cholesterol. With regular meal, both group had low triglyceride, total-cholesterol, atherogenic index, and blood sugar with women having low LDL-cholesterol. For both groups, the triglyceride, total-cholesterol, LDL-cholesterol, atherogenic index, and blood sugar had higher figures for overeating, with men having low HDL-cholesterol and women having high HDL-cholesterol. This study revealed that less number of overeating, regular mealtime, and less volume of food intake are effective in preventing and treating for the cardiovascular diseases.