• International Journal of Internet, Broadcasting and Communication
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• 제13권1호
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• pp.1-10
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• 2021

The type approval system for railway vehicle has been in effect since 2016 in order to establish a regular safety management system to secure railway safety and enhance the technological competitiveness of the railway industry, abolished the conventional performance test system through the reform of the Railroad Safety Act in 2012. Until now, there has been appreciated it has been making significant contributions to railway safety and industry of operation and manufacturing companies, taking their place in accordance with the implementation of the system. But there has been no case of quantitative analysis on the effectiveness of the actual system. In this study, in order to examine the full-scale performance of the approval system and quantitatively analyze effectiveness, we identified and defined the relationships with the major elements of the type approval system based on system thinking principle and determined the calculated outcomes to relevant stakeholders. A method of establishing a type approval performance management system that can be grasped, utilized, and adjusted from a point of various stakeholders' views was proposed. This is expected to be more helpful in the implementation of the system, such as improving and applying quantitative effects to analysis by closely reviewing the effects and influencing factors of the type approval system based on the data accumulated through continuous performance management and reflecting to system improvement.

• 한국항해학회지
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• 제19권4호
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• pp.63-82
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• 1995

This paper is a study on standard testing method for type approval of DSC which is the main structure of the terrestrial communication. As authority inspecting offices and producers have no experience for type approval of relative equipments as adapting GMDSS. In this paper, it is to be improved the understanding for type approval ; a system, standard of technic and testing methods, etc and make better quality of relative equipments. Additionally it could help quality and quantity improvement in all radiocommunication parts. Of course, the regulation for type approval had made but most makers didn't know it correctly, so the method of solution have been studied. By result of this study, with comparision and analysis of structure and a condition of efficiency with adapting GMDSS is could help some problems slove in the field and gave testing method of machinery and tools, electrical conditions, came out measurement and did ways standard efficiency.

• 한국해양공학회:학술대회논문집
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• 한국해양공학회 2001년도 추계학술대회 논문집
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• pp.15-19
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• 2001

Electronic navigation system onboard have have been developed with recent technology based on new concept such as electronic chart date. The most valuable system of revolution in electronic navigation equipment is ECDIS, which have been developed in order to reduce work load of mariner and give an integrated information by simple means, especially to improve the safety of ship's navigation. In order to be sure the function of ECDIS is satisfied, The international standard have regulated the performance in the standard, so ECDIS should be type approved by the marine equipment authority of each government. There are three basic documents, IEC61174, IEC61162, IEC60945 issued by IMO(International Maritime Organization) which should be used for type approval system of each authority. IEC 61174 include the method of test and required results for operational and functional performance of test equipment. IEC61162 is for sensor interface and IEC60945 is related to the test of environmental condition for general marine radiocommunication equipment. In this paper, we investigate international standard in detail and current approval system of general marine equipment. After that, we present the possible structure of type approval of ECDIS and important considerations of approval system such that ECDIS should be tested as one system not be separated between S/W and H/W.

• 한국통신학회논문지
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• 제22권2호
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• pp.225-240
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• 1997

With the lanuch of the World Trade Organization(WTO) system, National and international trends toward more liberalized regulation of telecommunications terminal equipments drive the globalization of the telecommunications market. Despite of such trends, most countries have long viewed the type approval system as a major hindrance to overseas maketing because of a hodgepodge of diverse type approval system of telecommunications terminal equipments in each country. But, recently, many countries under these situations try to make a better understanding of respective requeirements of each country's many countries under these situations try to make a better understanding of respective requirements of each country'stype approval system, and where possible to strengthen commonalities, through referred to as "multual recognitio" system for the purpose of the development of procedures for hamonization oftype approval system in "one world, one market". Thus, this paper covers the definition, considerations and the case studies of mutual recognition between countries. Also, this paper suggests the desirable and general model of mutual recognition to be applied all the countries, which are being preparing and processing it.g and processing it.

• 한국정밀공학회:학술대회논문집
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• 한국정밀공학회 2013년도 춘계학술대회 논문집
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• pp.1603-1604
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• 2013

• 자동차안전학회지
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• 제14권4호
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• pp.106-112
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• 2022

The purpose of this study is to explore ways of improving the motor vehicles safety certification system in preparation for the deployment of Lv.4 or higher autonomous vehicles. In order to effectively achieve the objectives of this study, theoretical and empirical research methodologies were employed, including literature review of prior research, government-published data, etc.; comparative research on legislative cases of other countries regarding motor vehicles safety certification; historical and legal research on domestic systems; legal analysis to explore approaches for improvement, etc. Some argue that the type approval system is needed in preparation for deploying autonomous vehicles, but there are several limitations in moving to the type approval system from the self-certification system currently adopted in Korea. First, there is a possibility that the system may be in conflict with the Korea-U.S. MOU regarding Foreign Motor Vehicles (1988) and the Korea-U.S. FTA (2011); second, there is a risk of undermining the cause of the self-certification system, which is the autonomy of manufacturers; third, the boundary between autonomous vehicles and non-autonomous vehicles is unclear; and fourth, the type approval system may hinder technological competitiveness. On the other hand, considering that the Korea-U.S. FTA and the UNECE IWVTA recognize exceptions to deal with road safety and risks to human health or the environment, and have a pre-certification system for some auto parts such as pressure-resistant containers, it can be said that there is room to introduce the type approval system for supplementation purposes. To improve the motor vehicles safety certification system while ensuring the safety of autonomous vehicles of Lv.4 or higher, the targets of type approval should be defined and the criteria, procedures, etc. for type approval should be established. At the same time, the consistency between motor vehicle-related laws and harmonization with international standards need to be considered.

• Journal of Pharmaceutical Investigation
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• 제36권6호
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• 한국마린엔지니어링학회:학술대회논문집
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• 한국마린엔지니어링학회 2011년도 전기공동학술대회 논문집
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• pp.250-253
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• 2011

The cruise industry is one of the world's fastest growing device industry which is structural construction coasts are expensive. Cruise out-fittings are thirty times compare with general large vessels. According to the characteristics of materials or equipments, most equipments are imported from europe. At present domestic shipbuilding industries and minor enterprises have a hard times therefore enhancing technology for the cruise industry could be infused vitality on the industries. If domestic small and midium industries have high technology for the cruise ship, domestic small and midium industries can have global competitiveness compare with european equipment suppliers which has small-scale and high technology. Therefore on this study, cruise ship's new equipment development and a study for the performance assessment and classification type approval certificate was carried out.

• 한국항해항만학회:학술대회논문집
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• 한국항해항만학회 2004년도 춘계학술대회 논문집
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• pp.269-274
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• 2004

선박의 안전운항을 위한 각종 전자시스템의 개발과 도입은 항해사에게 필요한 각종 운항정보를 보다 신속하고 정확하게 파악하여 항해사의 운항 업무 부담을 경감할 뿐만 아니라 안전 운항에 보다 집중하게 한다. ECDIS는 전자해도를 이용한 선박항해용 시스템으로 성능과 시험에 대하여 각각 IMO와 IEC의 국제기준을 준수해야 한다. 그러나 국제기준의 내용이 명확하지 않고 추상적인 부분이 많이 실제 시험인증에의 적용에 어려움이 있다. 그러므로 명확한 세부기준을 각 시험항목별로 수립하였고 필요 항목에 대한 시험방법과 판정기준을 제시하였다. 특히 ECDIS가 표현하는 색에 대한 색차 시험을 위하여 측정 장비를 통해 측정된 값을 이용한 색차판정절차 및 관련 식을 구축하였고 실제 선박에서 겼을 수 있는 것과 동일한 센서 정보 입력이 가능하도록 모의신호생성기를 개발하여 인증시험에 활용할 수 있게 하였다. 최초의 성능표준에 추가된 백업장치 및 레스터 모드에 대한 시험기준도 함께 수립하여 선박항해용전자해도시스템 전체에 대한 성능 시험인증 기술을 개발하였다.

• 정보보호학회논문지
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• 제32권2호
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• pp.279-287
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• 2022

최근 사이버 위협이 고도화되고 해킹기술이 발달함에 따라 자동차, 선박 등 다양한 분야에서 사이버보안이 강조되고 있다. 이러한 추세에 따라 여러 산업 분야에서 기자재 및 시스템에 대한 사이버보안을 요구하고 있으며, 이에 관련된 인증 및 제도가 구체화 되고 있다. 본 논문에서는 산업 분야의 사이버보안 형식승인이 RMF와 같이 명시적으로 개발 단계별로 구분하지는 않으나, 시스템 개발 전주기에 사이버보안 요소가 반영되어야 한다는 공통요소가 있다는 전제하에 RMF와 비교하였다. 비교 대상으로 해상 사이버보안 형식승인을 선정하였으며, 이는 공식적인 사이버보안 형식승인의 예로 국내 유일의 국제 선박검사 기관인 한국선급의 형식승인을 예로 비교한 것이지 산업 분야의 사이버보안 형식승인을 대표한다는 의미는 아니다. 비교 결과 해상 사이버보안 형식승인 획득 절차는 RMF와 같이 개발 단계별로 구분하지 않지만, RMF와 같이 개발 전단계에 대해 사이버보안 요소 적용해야 하는 절차상의 공통점과 단계별 결과물에 대한 유사성을 확인하였다. 이에 따라 해상 사이버보안 형식승인 획득과정을 통해 개발된 시스템은 개발 전주기에 사이버보안 요소가 적용되었다고 판단할 수 있는 가능성을 확인하였다.