• 한국환경성돌연변이발암원학회지
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• 제22권4호
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• pp.296-302
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• 2002

In recent years, the safety of sunscreens have been challenged based on the reports of its adverse effects on users; dermatitis, allergic contact dermatitis, photoallergic contact dermatitis. In the toxicological aspect, the need to investigate the safety of sunscreens is steadily increasing. However, there were few studies on the correlation between sun protection factor (SPF) and the safety of sunscreens. The objective of this study was to assess whether there was a correlation between SPF and the skin irritation index of sunscreens. Octyl methoxycinnamate (OMC) was selected, which was the most frequently used (about 92% in korea and about 90% in the world) in sunscreens. In vitro SPF test was performed using the standard samples recommended by KFDA guideline. We examined primary and cumulative skin irritation and eye irritation of OMC standard sample as well as homosalate. As in vitro SPF was increased, skin irritation index was increased in primary skin irritation test ($r^2$=0.986) and cumulative skin irritation test ($r^2$=0.939). In addition, OMC was non-irritating and non-sensitizing. In this results, there was a good correlation between SPF index and skin irritation index.

• 재활복지공학회논문지
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• 제4권1호
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• pp.1-8
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• 2010

의료기기와 IT융합기술의 접목으로 인해 언제 어디서나 건강에 대한 측정을 가능하게 하였다. 또한, 최근에는 다양한 형태의 유헬스 의료기기가 개발되어 일상생활과 가정에서 자연스러우며 편리한 건강변수 측정이 가능하며, 디바이스의 보급과 더불어 이를 응용한 유헬스 디바이스에 대한 연구 및 개발이 우선되고 있는 현재, 이에 대한 안전성 확보 및 성능평가 기준 마련은 미흡한 실정이다. 이에 따라 시판전의 시험검사나 시판후의 수거 검사시에 안전성 및 성능평가를 위한 표준시험방법 개발이 필요하다. 본 논문에서는 유헬스 디바이스에 대한 전기적 안전성 평가를 위한 필수시험 및 성능평가를 위한 표준시험방법을 연구하였다.

• 한국병원경영학회지
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• 제29권1호
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• pp.1-18
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• 2024

Purposes: The Common Data Model(CDM) is very important for multi-institutional research. There are various domestic and international CDM construction cases to actively utilize it. In order to construct a CDM, different terms from each institution must be mapped to standard terms. Therefore, we intend to derive the importance and major issues of terminology mapping and propose a solution in CDM construction. Methodology/Approach: This study conducted terminology mapping between Electronic Health Record(EHR) and MOA CDM for constructing Medical Record Observation & Assessment for Drug Safety(MOA) CDM at Dankook University Hospital in 2022. In the process of terminology mapping, a CDM standard terminology process and method were developed and terminology mapping was performed by applying this. The constructions of CDM mapping terms proceeded in the order of diagnosis, drug, measurement, and treatment_procedure. Findings: We developed mapping guideline for CDM construction and used this for mapping. A total of 670,993 EHR data from Dankook University Hospital(January 1, 2013 to December 31, 2021) were mapped. In the case of diagnosis terminology, 19,413 were completely mapped. Drug terminology mapped 92.1% of 2,795. Measurement terminology mapped 94.5% of 7,254 cases. Treatment and procedure were mapped to 2,181 cases, which are the number of mapping targets. Practical Implications: This study found the importance of constructing MOA CDM for drug side effect monitoring and developed terminology mapping guideline. Our results would be useful for all future researchers who are conducting terminology mapping when constructing CDM.

• 대한환경공학회지
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• 제38권8호
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• pp.435-443
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• 2016

본 연구는 석유화학산업 시설에 MACT (Maximum Achievable Control Technology) 적용 시 벤젠 비산배출량 저감 효과를 분석 하였다. 국내에서는 2015년부터 대기환경보전법에 따라 벤젠 비산배출 저감 위한 규제를 시행하였으나, 미국 EPA에서는 이에 앞서 1995년부터 최대달성 가능한 통제기술인 MACT 기준을 적용하여 벤젠 비산 배출을 효과적으로 관리하고 있다. 본 연구를 위하여 벤젠 배출량 산정 방법론은 EPA Emission Factor AP-42 및 EPA MACT Standard Guideline를 활용하였다. 연구 결과 MACT 적용할 경우 Uncontrolled facility에 비하여 벤젠 배출량이 평균 98% 수준으로 저감 가능한 것으로 나타난 반면 National Regulation 경우 MACT 수준에 비하여 다소 낮은 평균 95% 수준의 저감율을 보이는 것으로 분석되었다. 그러나 MACT 기준 경우 벤젠 선박출하 시 유증기 회수설비(Vapor Recovery Unit, VRU) 등을 가동하여 배출 저감토록 요구하고 있음에도 불구하고 National regulation에서는 별도 규제 사항이 없는 실정이다. 추가적인 배출저감 달성을 위해서는 벤젠 선박출하 시 VRU 등 유증기 저감설비 도입의 법제화가 필요하다. 이러한 노력은 국내 석유화학산업의 벤젠 배출관리 능력을 Global 수준으로 향상시키는데 기여할 것으로 기대된다.

• 대한인간공학회지
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• 제32권4호
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• pp.321-331
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• 2013

Objective: The aim of this study is to review the literatures on the regulation, standard and guideline for the human vibration in Korea and other countries. Background: This review can be used to prevent various diseases caused by the human vibration as a basis for the development of the policy. Results: In Korea, the general employers' duties related to human vibration are set forth the Health Measures(Article 24) in the Occupational Safety and Health Act. And then an employer shall take measures to protect the health of the workers concerned by improving other working conditions relating to working hours for the vibration prevention measures referred to in Article 24 of the Act. The European Union adopted a Directive in 2002 on minimum requirements for the health and safety of workers exposed to vibration. New Regulations on Vibration at Work will be introduced in Great Britain on 2005 to implement the Directive. In the U.S., both ANSI and ACGIH adopted the ISO standard for measurement and suggested exposure action and limit values. In Japan, the Ministry of Labor decided that the vibration syndrome among operators of rock drills and riveters etc. could be included in an occupational disease(1947). In addition, ISO standard was based on proposals and draft documents of many countries such as U.K, Japan and European, etc. Conclusion: In Korea, Occupational Safety and Health Act prevent vibration to health, but do not include exposure limits. It is therefore important to consider the new duties regarding to vibration risks added to the general duties.

• 한국통신학회논문지
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• 제39C권10호
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• pp.896-908
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• 2014

세계적인 인구 고령화와 생활수준의 향상에 따른 국민들의 건강에 대한 관심이 커지면서 최근 전자의료기기의 시장도 증대되고 있다. 수지형체외식초음파프로브는 허가 신청 건수가 높은 다빈도 허가 심사 대상 의료기기이며 최근 병원 등의 임상분야에서 그 활용도가 높다. 하지만, 수지형체외식초음파프로브의 성능 평가를 위한 국내 기준은 명확하게 마련되지 않은 실정이고, 허가심사 및 품질평가 등을 위한 가이드라인 조차 마련되어 있지 않다. 따라서 본 연구에서는 수지형체외식초음파프로브의 특성, 허가 및 시장현황을 조사하고, 관련 국내 외 규격을 검토하여 성능평가 시험항목, 기준 및 방법을 도출하였으며, 시험검증을 통하여 최종적으로 국제조화되고 국내 실정에 적합한 성능 평가 가이드라인을 마련하였다. 향후 본 연구결과를 의료기기 관련 업체에서 활용함으로써 수지형체 외식초음파프로브의 품질 및 성능 향상을 도모하고, 허가를 위한 심사 평가의 일관성을 확보할 수 있을 것으로 기대된다.

• 한국식품위생안전성학회지
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• 제14권1호
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• pp.104-114
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• 1999

This study was conducted to find out the proper ways of implementation of Hazard Analysis Critical Control Point (HACCP) concepts applicable to the current Korean food inspection system. The following recommendations are based on an in-depth review of the Canadian Food Safety Enhancement Program (FSEP), which is one of the leading HACCP programs adapted to the food industry. Since 1997, the HACCP system has been voluntarily applied to meat processing plants in Korea in accordance with the Food Protection Law. But the guidelines are obscure and inadequate to expand to the diversity of food plants, and are therefore only applied to a limited number of plants of small scale enterprise. For these reasons, it is necessary to prepare an enhanced food safety control program focused not only on the HACCP plants but also on the non-HACCP plants. The national program should be the fundamental framework of a food safety control policy enforced by all the relevant authorities. The Prerequiste Program of Canadian Food Inspection Agency and Sanitation Standard Operating Procedures (SSOP) of FSIS are good example programs for the non-HACCP plants. These programs, which are a major part of the HACCP system, could easily be adapted to the Korean food industry. To improve the current HACCP implementation guideline, it is necessary to develop a detailed implementation manual, generic HACCP model, training program, and an audit program.

• 한국안전학회지
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• 제29권4호
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• pp.160-167
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• 2014

To determine a proper ASIL for each hazardous event with a proper safety goal, the right classes should first be determined for the three properties of the hazardous event; (i) severity of harm from the resultant accident, (ii) exposure to the relevant operational situation, and (iii) controllability to avoid the induced risks. ASIL can be clearly determined with right classes of these three properties. But no specific methodologies or processes for their classification can be found in ISO 26262, except only a rough guideline with a simplified set of illustrative tables. In this paper, we try to present a systematic model for classifying the three properties of the hazardous event and suggest a refined procedure of ASIL determination. The proposed model provides a specific method to get a more objective ASIL compared with that in the standard. Scrutinizing the current methodology, we develop a refined method and also provide an illustrative example.

• 인터넷정보학회논문지
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• 제22권6호
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• pp.59-69
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• 2021

의료기기의 오작동이나 고장은 인명 피해나 큰 상해가 발생할 수 있으므로 안전성 확보가 필수적인 분야이다. 이를 위해 국제표준을 제정하고 준수하도록 하고 있지만 이들 표준은 상호의존적이고 특히, 안전성 분석 활동의 경우 시간, 노력, 비용이 많이 소요되어 표준 활동을 통합하고 커스터마이징할 필요가 있다. 따라서 본 논문에서는 의료기기 소프트웨어 개발 단계별 수행 활동과 안전성 프로세스의 활동을 통합하였다. 통합된 프로세스를 통해 하나의 프로세스로 체계적인 관리가 가능하며, STPA 기법을 기반으로 하는 프로세스 단계별로 가이드가 제공되어 안전성 활동을 효과적으로 수행할 수 있다.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2021년도 봄 학술논문 발표대회
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• pp.247-248
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• 2021

Recently, the government is pursuing to reduce the serious accidents in most industries, including the construction industry, by enacting laws on punishment. The accident rate tends to be depended on the size and type of construction sites, and the accidents occur frequently due to inadequate implementation of safety management system and management standards, especially, in small and medium-sized sites. This study has performed the profiling of 265,000 accident cases on construction sites by attribute analysis such as the ratio of days lost to work, and pattern of days lost to work compared to the size of the construction. It turned out that the proportion of accident cases was high mainly in small-scale construction sites, and long-term labor losses occurred. Shortly, it is necessary to establish an institutional standard for applying a realistic safety management cost calculation and management system centered on small-scale sites. Therefore, this study is expected to be used as fundamental data or guideline for developing a customized safety management and accident prevention system for a worker reflecting the conditions of a construction site in the future.