• Title/Summary/Keyword: Conformity

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New Medical Device Regulations (MDR) in Europe (유럽의 새로운 의료기기 규제제도 MDR)

  • Jeong, Hyun-Woo;Yeom, Hojun;Park, Sangsoo
    • The Journal of the Convergence on Culture Technology
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    • v.8 no.5
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    • pp.29-37
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    • 2022
  • MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

The Relationship between Value Types and Life Satisfaction: Mediation Effect of Positive Affectivity (가치 유형과 삶의 만족 사이의 관계: 긍정 정서의 매개효과)

  • Joo, Mijung;Chong, Young-Sook;Lee, Jaesik
    • Asia-pacific Journal of Multimedia Services Convergent with Art, Humanities, and Sociology
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    • v.8 no.2
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    • pp.911-922
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    • 2018
  • The purpose of this study was to investigate the relationship between value types and life satisfaction of Korean university students. 275 students' scores for value types, positive·negative affectivity, and subjective well-being were obtained using questionnaires. Data was analysed by correlation analysis and path analysis. The results can be summarized as followings. First, the correlation between all negative affectivity and all value was not significant. Second, conformity, benevolence, self-direction·stimulation, hedonism, achievement and security value types were positively correlated with positive affectivity, whereas, conformity, benevolence, universalism and security value types were positively correlated with life satisfaction. Third, the student's higher scores of conformity, benevolence and hedonism value types induced higher level of positive affectivity, which, in turn, increased life satisfaction. The results suggested that value types can indirectly influence life satisfaction through positive affectivity.

Motivation for Z generation to consume limited edition products (Z세대 소비자를 움직이는 힘, 한정판)

  • Eunji Lee
    • The Journal of the Convergence on Culture Technology
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    • v.9 no.4
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    • pp.61-66
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    • 2023
  • In the past, purchasing limited products was nothing more than purchasing expensive luxury goods. However, the current 'Limited product purchase' is not just pay to ability, but the information to purchase the product are important factors. Therefore, this study aims to find out 1) the motivation to purchase limited edition products and 2) the effect of the motivation on the consumer's experience(price, intention to purchase). As a result, five major purchase motives(Conformity, Interest, Scarcity, Finance technology, Desire to concede) were found. Among them 'Interest' had a positive effect on the product purchase price, and 'Conformity' had a negative effect on the product price. Next, 'Interest' and 'Scarcity' had a positively significant effect on intention to purchase. Through this study, we were able to reveal in depth the actual purchase motives of consumers who are currently emerging as the main age group of the new consumption culture, and expect these purchase motives to be actively used in the new market such as resell markets.

Effect of Water-Containing Conditions on Concrete Substrates on Defects of Polyurethane-based Waterproofing Materials (콘크리트 바탕면의 함수조건이 폴리 우레탄계 방수재 하자에 미치는 영향)

  • Lee, Gun-Cheol;Kim, Jae-Yeob;Kim, Young-Min;Hong, Sung-Rok;Kim, Young-Sam;Shin, Hong-Chol
    • Journal of the Korea Institute of Building Construction
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    • v.23 no.1
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    • pp.1-9
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    • 2023
  • This study is to analyze the cause of the defects in polyurethane waterproofing, a material commonly used on the roof of buildings, and to determine if it has a relation with the curing conditions of humidity and temperature and the moisture content of the base structure. As a result, it was confirmed that the waterproofing coating did not adhere when the moisture content of the base plate was 10% or more. When the temperature and humidity conditions were 20℃ and 80%RH, none of the properties deteriorate but when the temperature was 40℃, 60%RH, air bubbles were formed on the surface, and at 40℃ and 80%RH, the basic properties of the dry coating film were less than the KS F 3211 performance standard.

Safety Evaluation of Ethanol Extract from Unripe Fruit of Bitter Melon (Momordica Charantia L.) in Sprague-Dawley Rats (랫드를 이용한 여주 추출물의 안전성 평가)

  • Ryu, Hyeon Yeol;Lee, Somin;Ahn, Kyu Sup;Yong, Yeon;Kim, Hye Jin;Kim, Seong-Eun;Lee, Hak Sung;Hong, Su-Young;Kim, Hyun-Kyu;Hwang, In Guk;Song, Kyung Seuk
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.46 no.4
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    • pp.490-500
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    • 2017
  • This study was performed to evaluate repeated dose oral toxicity upon administration of the test substance 1,2-benzisothiazolin-3-one for 90 days and to determine NOAEL (no observed adverse effect level) and target organs in Sprague-Dawley rats. Single, 2-week repeated, and 13-week repeated oral dose toxicity studies were conducted in Sprague-Dawley rats. The dose levels of groups were 1,250, 2,500, and 5,000 mg/kg/d. All dose groups were compared with the vehicle control group. The animals were observed for clinical signs and weekly body weight. Urinalysis, hematology, and serum biochemistry analyses were conducted. Subsequently, animals were sacrificed and subjected to histopathological examination. For the result, NOAEL of ethanol extract from unripe fruit of bitter melon had an optimal dose of 5,000 mg/kg/d and acceptable daily intake up to 3,000 mg/man. There was no target organ detected. Therefore, bitter melon, which contains a variety of bioactive substances, could be widely used as a health functional food ingredient.

Watertightness and Durability Properties of Ultra Rapid Hardening Grout using Bottom-ash (잔골재 대체재로서 바텀애쉬를 이용한 초속경 그라우트재의 수밀성 및 내구특성)

  • Lee, Gun-Cheol;Oh, Dong-Uk;Cho, Byoung-Young;Kim, Young-Geun;Cho, Chung-Ki
    • Journal of the Korean Recycled Construction Resources Institute
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    • v.6 no.3
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    • pp.102-109
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    • 2011
  • In this study, in order to develop ultra rapid hardening mortar(URHM) for tunnel repairs using bottom ash of low recycle ratio and Admixture as Eco concept, watertightness and durability properties of URHM on temperature condition of construction field were performed. Test result, seepage quantity and water absorption coefficient regarding watertightness of URHM were as in the following : series II > series I. Seepage quantity for the standard condition were smaller than low temperatures. all specimens were satisfied below 20g as standards of seepage quantity on KS F 4042. Because of the decrease of unit cement content by to replacement of blast furnace slag, the neutrlization resistance for durability properties was reduced. The result of alkali resistance and acide resistance, compressive strengths for specimens soaked in calcium hydroxide solution of seriesI were lower than compressive strengths for specimens not soaked. On the other hand, the case of series II show that the deterioration of compressive strengths for specimens was not almost showed. Compressive strengths of specimens soaked were similar with specimens not soaked except series II-C in $5^{\circ}C$. Therefore, specimens using both blast furnace slag and bottom ash were good in alkali resistance and acide resistance.

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Self-esteem and Life satisfaction In the Clothing Behavior-Age and Sex in Adult and Elderly Groups- (자아존중도와 생활만족도가 의복행동변인에 미치는 영향에 관한 연구-연령 및 성을 중심으로-)

  • 김순구
    • Journal of the Korean Society of Costume
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    • v.26
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    • pp.49-67
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    • 1995
  • The purpose of this study was to investigate the relationships between demographic and psychological variables and clothing behavior with reference to sex difference in adult and elderly groups. The clothing behavior was measured by Clothing importance, Interest, Conformity, Modesty, Psychological dependence, Aesthetics, Management, Fashion, and Clothing satis-faction. Psychological variables in this study were self-esteem and life-satisfaction, and demographic variables were sex, education, family type, health, and clothing expenditure. The hypotheses set up in this study were as follows : First, a causal relationship will exist between demographic and psychological variables and clothing behavior in both adult and elderly groups. Second, in clothing behavior a main effect will exist between male and female groups and between adult and elderly groups. Third, in clothing behavior and interaction effect will exist between sex and age. The subjects of this study were 496 adult males, 459 elderly males, and 446 elderly females residing in Pusan area. The material used in this study to measure the clothing behavior was a 5-point rating scale with 31 items in 9 sub-areas developed by the author. The data were collected by five investigatiors well trained in interview before-hand. The following conclusions were obtained from the relults and discussions of this study : First, sex, education, and clothing expendi-ture has a causal relationship with clothing behavior in adult group. Females, higher-educated group, and the group with more clothing expenditure reveal higher concern for clothing. In adult group life-satisfaction does not have any causal relationship with clothing behavior in general execpt for clothing satis-to Psychological dependence, Aesthetics, Management, and Clothing satisfaction in the group. Second, in elderly group sex, education, and health significantly contribute to clothing behavior. A cencern for clothing is higher in female, higher-educated group, and the group with higher perception in health. Self-esteem has a causal relationship with Clothing importance, Conformity, Management, and Clothing satisfaction, whereas life-satisfaction has a strong causal relationship with clothing behavior in general. Third, in both adult and elderly groups a sig-nificant sex diference exists in clothing behavior. Females show higher concern for Clothing importance, Interest, Psychological dependence, Aesthetics, Management, and Fashion than males. On the other hand, males reveal higher concern for Conformity and Clothing satisfaction than females. Fourth, a significant interaction effect exists between age and sex, while elderly females show lower concern for Clothing importance, Interest, and Psychological dependence than adult females, elderly males show higher concern for the same sub-areas of clothing behavior than adult males. This signifies the increase of the concern for clothing in elderly males with the decrease of social activities. Fifth, adult female group reveals lower Con-formity in clothing compared with the other groups, which signifies the higher individuality in clothing behavior. On the other hand, the elderly groups show significantly higher Conformity than the adult groups. this signifies the importance of the consideration for the variables other than individuality in clothing behavior for the group.

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Mainstream smoke level of harmful substances in korean domestic cigarette brands

  • Choi, Hyun Doc;Song, Seok Ho;Cho, Hoonsik;Kim, Hyung Kyung;Lee, Jin-Hee;Yoon, Soon-Byung;Heo, Seok;Park, Hyoung-Joon
    • Analytical Science and Technology
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    • v.31 no.1
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    • pp.14-22
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    • 2018
  • After signing the WHO FCTC in 2003, South Korea ratified the FCTC in 2005. This study was conducted to provide data on toxic constituents that can be used as useful information for the level of exposure to Korean smokers. Emissions data from five brands of cigarettes were tested under the ISO and "Canadian Intense (HCI)" smoking regimes, respectively. We conducted an analysis of 25 compounds containing nicotine, tar, carbonyls, phenolics, volatile organic compounds (VOCs), and semi-VOC cigarette smoke. Tar and nicotine showed levels of 4.3 to 5.8 mg/cig and 0.4 to 0.5 mg/cig, respectively, which are within the range of tolerance presented in ISO 8243. In the case of carbonyls, formaldehyde was detected within a range of 8.2 to $14.3{\mu}g/cig$, and acetaldehyde was present within a range of 224.7 to $327.2{\mu}g/cig$ under the ISO smoke regime. Crotonaldehyde was not detected under the ISO regime, and all of the carbonyls showed values 2.3 to 4.5 times higher under the HCI regime than those under the ISO regime. Catechol, which showed a level of 47.0 to $80.5{\mu}g/cig$ under the ISO regime and 117.5 to $184.7{\mu}g/cig$ under the HCI regime, was the highest constituent among the phenols. The amount of isoprene was 91.7 to $158.3{\mu}g/cig$ under the ISO regime and 221.0 to 377.0 under the HCI regime. To summarize, most of the constituents showed a tendency to be detected at levels 2 to 4 times higher under the HCI regime than under the ISO regime. Above all, these results represent the first analysis in Korea from an independent institute of tobacco companies under accreditation of ISO 17025.

Evaluation for Properties of Domestic Pond Ash Aggregate and Durability Performance in Pond Ash Concrete (국산 매립회의 골재특성 평가 및 매립회 콘크리트의 내구 성능 평가)

  • Lee, Bong-Chun;Jung, Sang-Hwa;Kim, Joo-Hyung;Kwon, Seung-Jun
    • Journal of the Korea Concrete Institute
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    • v.23 no.3
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    • pp.311-320
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    • 2011
  • Fly ash (FA), byproduct from power plant has been actively used as mineral admixture for concrete. However, since bottom ash (BA) is usually used for land reclaim or subbase material, more active reuse plan is needed. Pond ash (PA) obtained from reclaimed land is mixed with both FA and BA. In this study, 6 PA from different domestic power plant are prepared and 5 different replacement ratios (10%, 20%, 30%, 50%, and 70%) for fine aggregate substitutes are considered to evaluate engineering properties of PA as fine aggregate and durability performance of PA concrete. Tests for fine aggregate of PA for fineness modulus, density and absorption, soundness, chloride and toxicity content, and alkali aggregate reaction are performed. For PA concrete, durability tests for compressive strength, drying shrinkage, chloride penetration/diffusion, accelerated carbonation, and freezing/thawing are performed. Also, basic tests for fresh concrete like slump and air content are performed. Although PA has lower density and higher absorption, its potential as a replacement material for fine aggregate is promising. PA concrete shows a reasonable durability performance with higher strength with higher replacement ratio. Finally, best PA among 6 samples is selected through quantitative classification, and limitation of PA concrete application is understood based on the test results. Various tests for engineering properties of PA and PA concrete are discussed in this paper to evaluate its application to concrete structure.

Isothermal Conduction Calorimetry Analysis of Alkali Activated Slag Binder (알칼리 활성 슬래그 결합재의 미소수화열 분석)

  • Choi, Young-Cheol;Cho, Hyun-Woo;Oh, Sung-Woo;Moon, Gyu-Don
    • Journal of the Korean Recycled Construction Resources Institute
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    • v.3 no.3
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    • pp.237-243
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    • 2015
  • In this research, isothermal conduction calorimetry analysis has been conducted to investigate the reactivity of alkali activated slag binders. In order to secure the reactivity and workability of alkali activated slag binders, experiences with various types and concentrations of alkali activators were performed. Isothermal conduction calorimetry were measured with different alkali activators and mass ratio of $SO_3$ to binders as variables, and sodium tripolyphosphate ($Na_2P_3O_{10}$) and hydrated sodium borate ($Na_2B_4O_710H_2O$) were used to control setting time. As a results, alkali activated slag binders required alkali activators with 4 to 5 percent of concentration to accelerate the formation of calcium silicate hydrate(C-S-H) by alkali-activation, and overall heat generation rate delayed as accumulated heat decreased due to the high $SO_3$ contents. Moreover, the use of hydrated sodium borate as setting retarder causes elongated setting time due to delaying heat generation, so it can be considered that setting retarder played an important role in delaying total heat generation rate.