• Journal of Biomedical Engineering Research
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• 제31권6호
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• pp.434-437
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• 2010

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

• Journal of the Korean Society of Food Science and Nutrition
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• 제43권2호
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• pp.309-317
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• 2014

The purpose of this study was to investigate convenience foods at convenience stores, by examining consumption patterns, as well as the degree of checking food-nutrition labeling. In this study, 208 workers in Busan in their 20s or 30s were surveyed using 1:1 interview questionnaires. The weekly usage frequencies of cup-ramyeon, gimbap, ramyeon, and sandwiches were 41.0%, 39.4%, 32.7%, and 19.0% respectively. The usage frequency of convenience foods was 12.0% for 'over 5 times/week', 23.0% for '3~4 times/week', 31.7% for '1~2 times/week', 29.8% for '1~2 times/month', and 3.4% for zero usage. Workers in their 20s showed a significantly (P<0.05) higher rate in the '3~4 times/week' as well as '1~2 times/week' intervals than workers in their 30s. Single people showed a significantly (P<0.01) higher rate than married people. Workers in their 20s showed a significantly higher score for the '3~4 times/week' as well as '1~2 times/week' intervals (P<0.05). The mean score of checking food labeling was 4.02/5.00 for the manufacturer's date, or expiration date, 3.23/5.00 for weight or volume, 2.99/5.00 for cooking method, and 2.85/5.00 for storage method. Females showed significantly (P<0.01) higher rates for checking the manufacturer's date or expiration date, as well as source of the raw material. Single workers showed significantly (P<0.01) higher rates for checking the manufacture's or expiration date as well as storage method. The mean score for checking nutrition labeling was 3.06/5.00 for calories, 2.84/5.00 for trans fat, 2.80/5.00 for sodium, and 2.76/5.00 for cholesterol. Females showed a significantly (P<0.01) higher rate for six of 10 items. Workers in their 20s showed a significantly (P<0.05) higher rate for four of 10 items. Expert officials showed significantly higher rate for six of 10 items (P<0.05) and two of 10 items (P<0.01), respectively.

• Journal of Dairy Science and Biotechnology
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• 제31권1호
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• pp.59-65
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• 2013

Antibiotic residues are undesirable in milk and milk products for a number of reasons. In particular, they can have harmful effects on public health and harm to the manufacturer of the cultured milk products, e.g. MRSA etc. Although government regulatory agencies and the dairy industry have been successful in decreasing the presence of high concentrations of antibiotic residues, violations still occur and lead to contaminated products. As a result, several rapid and reliable methods for the detection of antibiotic residues have been developed, including microbiological and instrumental analysis methods. The conventional methods are time consuming, but recent improvements have allowed for better detection time, sensitivity, and accuracy. An example of an advanced detection instrument is the biosensor, which has several applications in food and environmental science, e.g. food-born pathogen detection, antimicrobial residues etc. In the present review, the recent trends in the methods used to test for antibiotic residues in milk and dairy products, as well as their specific applications, have been discussed.

• Journal of the Korean Society of Manufacturing Process Engineers
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• 제17권5호
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• pp.76-83
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• 2018

A cabinet-door integrated finite element model was constructed for a built-in side-by-side refrigerator with an ice dispenser, and its deformation was analyzed using the ANSYS finite element software. As loads, the food load needed to fill in the cabinet and doors and the thermal load occurring during normal operation conditions were taken into consideration. The door height difference (DHD) and door flatness difference (DFD) between the two doors of the freezing and refrigerating compartments were derived. The DHD and DFD under the assembled condition without applied loads satisfied the acceptance criteria specified by the refrigerator manufacturer. It appeared that the food load increases the DFD slightly. The thermal load tends to increase the differences because of the thermal deformation, especially the DFD, of the cabinet and doors.

• The Korean Journal of Food And Nutrition
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• 제21권4호
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• pp.562-571
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• 2008

The principal objective of this study was to assess dietitian's awareness and performance with regard to food suppliers' selection guidelines and purchase guidelines for the receipt of safe food materials. A questionnaire was administered to 203 dietitians working at an elementary school in Gyeonggi North province, and 190 responses were ultimately returned. Excluding responses with incomplete answers and significant missing data, 161 responses(79.3%) were ultimately utilized for data analysis. We determined that meat/poulty and seafood were purchased mainly by manufacturer's branch(59.8% and 78.3%), and processed food and kimchi were generally purchased by producer's cooperatives(47.7% and 44.9%). 78.3% of the contracts were made via informal purchasing and the frequency of contracts was less than 3 times per year(53.4%). Market studies were conducted individually(54.7%), and by group(47.2%). Dietitian and parents volunteered(50.3%) or dietitians, and school and foodservice staffs(45.3%) participated - together in receiving and inspection. School contracted with $4{\sim}5$(39.1%) and $6{\sim}8$ food suppliers(29.8%). Dietitians(42.3%) or school councils(40.2%) evaluated food suppliers once per semester(60.2%). The majority of dietitians(96.3%) conducted sanitary education for food suppliers once per semester (68.3%). All 13 guidelines which were usually used to evaluate food suppliers were thought to be important(more than 4) based on a 5 scale(1: never important, 5: very important). Among them, 'sanitary storage status of food products(4.85)', 'have a chill car(4.83)' and 'proper control of refrigerator, freezer and storage room(4.81)' were the most crucial guidelines. As dietitians evaluated food supplier's-observances of 13 guidelines, 'have a chill car(4.89)', 'hold medical examination of employees(4.89)' and 'hold liability insurance for handling product(4.80)' were fulfilled relatively well. The guidelines for conducting education for their employees(4.45) and keeping their establishment and equipment sanitary(4.79) were important, but were not observed well(3.39 and 3.37). Additionally, the difference between the importance and the observance score of the 'HACCP certificate' were fairly significant(4.44 and 3.54). Dietitians tended to report that purchasing management related to the removal of foodborne illness factors(4.71), return confirmation(4.50) and purchase specification(4.32) were important. The difference between importance and performance was highest in the process of changing food suppliers when the contracts were violated more than three times. Dietitian's age, education work experience and employment type had no observable effects on how important they considered purchase management to be, but their work experience significantly affected performance in terms of the removal of foodborne illness factors(p<0.05). As supplier management is the most critical factor, it is clearly desirable to educate suppliers at specialized training centers and to supervise suppliers in accordance with the established sanitary guidelines.

• Communications for Statistical Applications and Methods
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• 제5권2호
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• pp.491-501
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• 1998

Motivated by bioequivalence studies which involve comparisons of pharmaceutically equivalent dosage forms, we propose a more general decision rule for showing equivalence simultaneously between multiple means and a control mean. Namely, this testing procedure is concerned with the situation in that one must make decisions as to the bioequivalence of an original drug product and several generic formulations of that drug. This general test is developed by considering a spherical confidence region, which is a direct extension of the usual t-based confidence interval rule formally approved by the U.S. Food and Drug Administration. We characterize the test by the probability of rejection curves and assess its performance via Monte-Carlo simulation. Since the manufacturer's main concern is the proper choice of sample sizes, we provide optimal sample sizes from the Monte-Carlo simulation results. We also consider an application of the generalized equivalence test to a repeated measures design.

• The Korean Journal of Food And Nutrition
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• 제24권4호
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• pp.509-519
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• 2011

The purpose of this study was to investigate the use behavior and satisfaction of home-baking premix products. A total of 275 questionnaires were completed and statistically analyzed by the SPSS 14.0 package. The reasons for home-baking were : fun(33.8%), quality time with the family(33.8%), and distrust in foodstuffs(13.5%). The respondents(38.9%) used home-baking premix products 2~3 times per year. And the respondents purchased home-baking premix products primarily for snack foods(83.3%). Among the selection attributes of home-baking premix products, the respondents considered the importance of 'sanitation'(m=4.16) a top priority, followed by 'taste'(m=4.15), 'ease of use'(m=4.12), 'detailed instructions' (m=4.05), 'quality of raw materials'(m=4.04), and 'origin'(m=3.91). However, in the case of satisfaction, 'ease of use' (m=3.81) was the most satisfying aspect, followed by 'detailed instructions'(m=3.67), 'sanitation'(m=3.56) and 'manufacturer' (m=3.48). According to importance-performance analysis(IPA), 'quality of raw materials' and 'origin', which were selection attributes, should be quickly improved. Also, 'taste', 'ease of use', 'detailed instructions' and 'sanitation' should be maintained. This survey found that the satisfaction levels for home-baking premix product selection attributes had a significant influence on overall satisfaction($F$=7.91, $p$ <0.001). In particular taste(${\beta}$=0.32, $t$=3.53, $p$ <0.001) had a meaningful effect on overall satisfaction. In addition, the satisfaction levels for home-baking premix product selection attributes affected repurchase intention($F$=8.61, $p$ <0.001).

• Journal of Nutrition and Health
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• 제53권6호
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• pp.648-662
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• 2020

Purpose: Sodium intake is persistently decreasing because of the government's sodium reduction policy. This study aimed to identify foods and dishes that contributed to the reduction of sodium intake and evaluate the effects of the sodium reduction policy. Methods: The subjects were 57,809 participants in the Korea National Health and Nutrition Survey from 2010 to 2017. To identify food and dish sources of sodium intake, the food and dish groups were classified into 23 and 21 groups, respectively. Foods and dishes that contributed to sodium intake were categorized according to the production and cooking venues: production by manufacturers, home cooking, cooking at catering service, and restaurant cooking. Results: Sodium intake was 4,876 mg in 2010 to 3,477 mg in 2017, showing a 29.7% decrease in intake in 2010. Sodium intake was decreased mainly in foods produced by manufacturers and home-cooked foods. The main contributory factors to sodium from the food and dish groups differed according to the food manufacturer and cooking venue. The kimchi produced by manufacturers, cooked soup/tang/jjigae/hotpot at home and catering services, and cooked noodles/dumplings in restaurants were the main contributors to the sodium intake. Conclusion: The type of foods and dishes that contribute to sodium intake tended to expand over the years from specific foods and dishes to various groups of foods and dishes. These results provide evidence for the development and production of low-salt foods and dietary education related to low-salt intake.

• Journal of radiological science and technology
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• 제41권4호
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• pp.329-337
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• 2018

This study was investigated quantitative ultrasound (QUS) usage in Korea for the QUS quality control guidelines. A total of 344 questionnaires collected from July 24th to August 25th 2017 were analyzed. Questionnaires were created through user interviews, expert group advice, literature review and field observation. As a result of the general characteristics of quantitative ultrasound holding amounted to 81.98% of clinic and 6.69% of hospitals. The main user was radio-logical technologists as 31.39%. The contact methods of the gel pad (balloon) were the most used at 56.68% and the scan region was 91.9% of calcaneus. The quantitative ultrasound quality control cycle was 67.37% when the abnormality was found in the equipment, and 63.66% when the accuracy control was implemented according to the manual. The phantoms of QUS were 34.30% of the manufacturer's own phantoms. User of QUS had never received education for quality control of quantitative ultrasound as 62.20%. This study was expected to be useful when creating detailed quality control guidelines in the future, as well as guidelines for the quality control of Korea's standard quantitative ultrasound.

• Korean Journal of Community Nutrition
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• 제23권4호
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• pp.341-351
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• 2018

Objectives: Use of dietary supplements containing vitamins and minerals is growing in Korean adults, especially in pregnant and lactating women. Vitamin and mineral supplements are available in different composition and in a wide range of contents. The purposes of the study were to examine nutrient composition and content of vitamin and mineral supplements for pregnant and lactating women and assess their appropriateness as dietary supplements. Methods: Information on the name, manufacturer, nutrient composition, and usage of vitamin and mineral supplements for pregnant and lactating women were obtained from the homepage of the Food Safety Information Portal managed by the Ministry of Food and Drug Safety, and Korean Index of Medical Specialties. A total of 264 products were identified. Results: Among 264 products, 26.1% were single nutrient products, and 73.9% were multinutrient products. The most commonly included nutrient was iron (70.1%), folic acid (66.3%), vitamin $B_{12}$ (45.8%), vitamin C (38.6%), and vitamin $B_6$ (38.6%). Although more than 50% of products contained nutrients less than 150% of Recommended Nutrient Intakes or Adequate Intakes for daily use, some products contained inappropriately high amounts of nutrients. When a maximum daily dose of supplements was taken as described on the label, iron in 73 products (39.5%), folic acid in 14 products (8.0%) were likely to be consumed in amounts greater than Tolerable Upper Intake Levels. Most products were assessed as inappropriate for pregnant women due to the possibility of excessive intake of vitamins or minerals when compared with Dietary Reference Intakes. Conclusions: Pregnant and lactating women need to carefully select dietary supplements containing adequate amounts of vitamins and minerals. Nutritionists should provide guidelines regarding selection of appropriate vitamin and mineral supplements for pregnant and lactating women.