• 대한의용생체공학회:의공학회지
• /
• 제42권6호
• /
• pp.277-286
• /
• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• 자원ㆍ환경경제연구
• /
• 제31권4호
• /
• pp.777-799
• /
• 2022

본 연구는 지구온난화잠재력(GWP)이 매우 큰 냉매가스에 대한 EU의 최신 규제 강화 동향을 살펴보고 탄소중립에의 시사점을 도출하였다. EU집행위는 최근 F-가스 규정(Regulation)을 대폭 강화하는 개정안을 공개하였다. 본 연구는 개정안의 냉매 관련 주요 내용의 의미를 현행 규정과 비교해 제시하였다. 개정안의 주요 내용은 시장출시 허용 HFC 최대량 대폭 축소, HFC 할당 관련 규정 강화, 고GWP 냉매 사용 제품 및 장비의 시장출시 금지 대상 추가, 규제대상 F-가스 추가 및 기존 가스의 GWP 업데이트, 그 외에도 보다 촘촘해지고 강화된 규제설계등이다. EU의 이러한 움직임은 미국, 일본 등 선진국의 정책기조에 영향을 미칠 것이며, 우리나라의 정책도 더욱 강화될 것이다. 따라서 관련 산업계에서는 차세대 냉매가스로의 변경이 불가피한 상황이 될 것이다. 한편, 본 연구는 기존의 냉매 및 F-가스 관련 연구에서는 주목하지 않았던 과불화화합물(PFAS) 규제와 관련된 최신 정책 동향에 대해서도 분석하였다. 유럽 5개국의 추진하고 있는 PFAS의 REACH(EU의 화학물질 등록, 평가, 승인 및 제한 제도) 제한물질 등록이 이뤄지게 된다면, 냉매가스와 관련해서는 산업계에 매우 큰 파장을 불러일으킬 것이다. 또한, 냉매를 비롯한 F-가스 물질과 관련된 각국의 온실가스 감축 전략도 전면 재검토가 불가피해질 것이다.

• 한국산업보건학회지
• /
• 제25권2호
• /
• pp.115-125
• /
• 2015

Objectives: The major objectives of this study are to review the EU CLP Regulations to propose ways of improving the reliability of MSDS and labels. Methods: To review the EU CLP Regulations, we used EU documents including directives and regulations on chemical management. In addition, we used EU governmental agency reports to illuminate the history and background of the CLP. We found the EU CLP's instruments for reliable hazard communication and evaluated the operations of the instruments. Results: EU CLP Regulations have four instruments for the EU CLP Regulations to make hazard communication reliable. These instruments are GHS, the harmonized CMR and respiratory sensitive substances classification list, C&L inventory and restriction of trade secrets. These are highly useful for achieving the objectives of REACH and CLP(no data-no market and changing the burden of proof). Conclusions: Changing the burden of proof is a key principle for achieving a society safe from hazardous chemicals. Chemical manufacturers and importers alone should bear the responsibility for reliable MSDS. We recommend benchmarking the EU CLP Regulations in order to change efficiently the burden of proof. Trade secrets should be limited to low-hazard substances and be approved by the government before the chemical product is on the market. Like the C&L inventory, chemical product information including substances identification and hazard properties should be notified, aggregated and be opened to public on the Internet. Finally, we recommend a MSDS registration system once again.

• Environmental Analysis Health and Toxicology
• /
• 제30권
• /
• pp.17.1-17.6
• /
• 2015

Objectives In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the "Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)" were analyzed. Methods The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. Results Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. Conclusions Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure-Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.

• 한국재료학회지
• /
• 제29권6호
• /
• pp.356-362
• /
• 2019

$BaSiO_3:RE^{3+}$ (RE = Sm or Eu) phosphor powders with different concentrations of activator ions are synthesized using the solid-state reaction method. The effects of the concentration of activator ions on the structural, photoluminescent, and morphological properties of the barium silicate phosphors are investigated. X-ray diffraction data reveals that the crystal structure of all the phosphors, regardless of the type and the concentration of the activator ions, is an orthorhombic system with a main (111) diffraction peak. The grain particles agglomerate together to form larger clusters with increasing concentrations of activator ions. The emission spectra of the $Sm^{3+}$-doped $BaSiO_3$ phosphors under excitation at 406 nm consist of an intense orange band at 604 nm and three weak bands centered at 567, 651, and 711 nm, respectively. As the concentration of $Sm^{3+}$ increases from 1 to 5 mol%, the intensities of all the emission bands gradually increase, reach maxima at 5 mol% of $Sm^{3+}$ ions, and then decrease significantly with further increases in the $Sm^{3+}$ concentration due to the concentration quenching phenomenon. For the $Eu^{3+}$-doped $BaSiO_3$ phosphors, a strong red emission band at 621 nm and several weak bands are observed. The optimal orange and red light emissions of the $BaSiO_3$ phosphors are obtained when the concentrations of $Sm^{3+}$ and $Eu^{3+}$ ions are 5 mol% and 15 mol%, respectively.

• 한국환경보건학회지
• /
• 제47권5호
• /
• pp.432-445
• /
• 2021

Background: The European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment (ECETOC TRA) tool has been recognized by EU REACH as a preferred approach for calculating worker health risks from chemicals. Objectives: The applicability of the ECETOC TRA to occupational exposure estimation from industrial uses of methanol was studied by inputting surveyed and varied parameters for TRA estimation as well as through comparison with measured data. Methods: Information on uses of methanol was collected from seven working environment monitoring reports along with the measured exposure data. Input parameters for TRA estimation such as operating conditions (OCs), risk management measures (RMMs) and process categories (PROCs) were surveyed. To compare with measured exposures, parameters from the surveyed conditions of ventilation but no use of respiratory protection were applied. Results: PROCs 4, 5, 8a, 10, and 15 were assigned to ten uses of methanol. The uses include as a solvent for manufacturing sun cream, surfactants, dyestuffs, films and adhesives. Methanol was also used as a component in a release agent, hardening media and mold wash for cast products as well as a component of hard-coating solution and a viscosity-controlling agent for manufacturing glass lenses. PROC 8a and PROC 10 of a cast product manufacturer without LEV (local exhaust ventilation) and general ventilation as well as no respiratory protection resulted in the highest exposure to methanol. Assuming the identical worst OCs and RMMs for all uses, exposures from PROC 5, 8a, and 10 were the same and the highest followed by PROC 4 and 15. The estimation resulted in higher exposures in nine uses except one use where measured exposure approximated exposures without RMMs. Conclusions: The role of ECETOC TRA as a conservative exposure assessment tool was confirmed by comparison with measured data. Moreover, it can guide which RMMs should be applied for the safe use of methanol.

• 통상정보연구
• /
• 제16권4호
• /
• pp.191-225
• /
• 2014

유럽연합(European Union)은 1952년 7월, 파리조약(Treaty of Paris)을 체결한 이후 1958년 1월 로마조약, 유럽공동체(EC 조약), 1993년 11월 마스트리히트 조약(Treaty of Maastricht), 1999년 5월 암스테르담 조약(Treaty of Amsterdam), 2002년 10월 니스 조약(Treaty of Nice), 2009년 12월 리스본 조약(Treaty of Lisbon) 조약을 체결하여 유럽의 정치 및 경제적 통합을 모색하여 왔다. 현재 EU는 28개 회원국을 두고 있으며 2012년 기준으로 총 5억 명 이상의 인구, 역내 GDP가 16조 6,090억 달러에 이르며 세계 GDP의 3분의 1을 차지하는 세계최대의 경제권이다. 우리나라와는 3위의 교역상대국이다. 지금까지 우리나라는 주로 EU에 자동차, 반도체, 휴대폰, 조선과 그 부품 등의 공산품을 수출하여 왔다. 그러나 EU가 최근 미국과 FTA를 적극 모색하고 러시아와도 경제 협력을 도모하며 중국 기업들도 EU로의 진출을 적극 추진하고 있어 우리 기업의 입지가 위축될 여지가 있는 실정이다. 또한 EU는 평균 수입관세율이 낮고 비교적 가장 개방된 거래 시장이지만 크고 작은 진입장벽은 상존하여 EU의 관세 및 비관세 장벽에 대한 이해가 필요하다. 이에 본 연구는 EU 시장 개척을 위한 가장 초보적이고 기초적인 연구로 EU의 관세 및 비관세 장벽(Non-Tariff Barriers)에 관해 검토하여 우리나라 기업에게 시사점을 제시하기 위해 연구되었다.

• 환경정책연구
• /
• 제8권3호
• /
• pp.81-113
• /
• 2009

본 논문은 기업의 환경경영활동과 지속가능한 발전과의 상관관계를 분석하는 것을 목적으로 하였다. 이를 위해 기업의 환경경영활동을 지속가능성 측면에서 평가할 수 있도록 경제, 환경, 그리고 사회적 지표를 선정하여 평가모형(SDEM)을 구축하였다. 평가모형은 델-파이, 계층적 분석방법(AHP)을 활용하여 자료의 선정과 가중치를 결정하였다. 그리고 우리나라 기업 58개사를 대상으로 실증분석을 수행하였다. 분석결과에 따르면 환경경영 도입 단계가 높을수록, 기업규모가 클수록, 환경경영을 실천한지 오래될수록, 그리고 공기업일수록 지속가능한 발전에 미친 성과가 높은 것으로 분석되었다. 또한 경제적 성과와 환경적 성과와의 상관관계가 높은 것으로 나타났다. 또한 공기업이 민간기업에 비해 보다 높은 성과를 보이는 것으로 분석되었다.

• 국제지역연구
• /
• 제16권1호
• /
• pp.123-146
• /
• 2012

본 논문은 21세기 전 지구촌의 국제경쟁질서와 공정사회의 달성을 위한 새로이 제기되고 있는 이론, 정책, 제도와 법체제의 대안을 고찰하였다. 특히, 우리는 세계화에서 새로운 자유무역질서와 공정사회로서의 시장촉진과 공정거래를 위한 국제수준의 경쟁질서와 경쟁법체제의 기준을 연구하지 않으면 안 된다. 본 논문에서는 첫째, 세계무역기구(WTO)에서 새로운 자유무역의 공정거래를 위한 경쟁질서와 공정사회의 역사성과 기본적인 규범을 연구하였으며 둘째로, 새로운 세계화정책에서 비경쟁행위의 규제체계와 시장경쟁촉진을 위한 상거래유형과 법체계의 윤곽을 연구하였다. 더욱이, 우리는 WTO에서 경쟁질서와 공정사회를 저해하는 요인을 현실적 카테고리에서 연구하였다. 셋째로, 미국-EU와 한국-일본의 경쟁질서와 경쟁법의 적용범주 및 적용사례를 연구하였다. 끝으로, 본 논문은 21세기 최적의 국제경쟁질서와 공정사회의 달성관점에서 다양한 새로운 이론, 정책, 제도와 경쟁법의 연구를 토대로 새로운 대안과 시사점을 제시하였다.

• 한국산업보건학회지
• /
• 제24권2호
• /
• pp.208-218
• /
• 2014

Objectives: The major objective of this study was to develop and validate a tier 1 exposure model utilizing worker exposure monitoring data and characteristics of worker activities routinely performed at construction sites, in order to estimate worker exposures without sampling. Methods: The Registration, Evaluation, Authorization and Restriction of Chemicals(REACH) system of the European Union(EU) allows the usage of exposure models for anticipating chemical exposure of manufacturing workers and consumers. Several exposure models have been developed such as Advanced REACH Tools(ART). The ART model is based on structured subjective assessment model. Using the same framework, a tier 1 exposure model has been developed. Worker activities at construction sites have been analyzed and modifying factors have been assigned for each activity. Korean Occupational Safety and Health Agency(KOSHA) accrued work exposure monitoring data for the last 10 years, which were retrieved and converted into exposure scores. A separate set of sampling data were collected to validate the developed exposure model. These algorithm have been realized on Excel spreadsheet for convenience and easy access. Results: The correlation coefficient of the developed model between exposure scores and monitoring data was 0.36, which is smaller than those of EU models(0.6~0.7). One of the main reasons explaining the discrepancy is poor description on worker activities in KOSHA database. Conclusions: The developed tier 1 exposure model can help industrial hygienists judge whether or not air sampling is required or not.