철도안전법의 제작자 승인 기술기준에 대한 연구

이환덕(Hwan-Deok Lee),정원(Won Jung) 한국신뢰성학회 2015 신뢰성응용연구 Vol.15 No.1

The amended law of railway safety in Korea has recently come into effect in order to strengthen the railway safety management system. The new law, which took effect March 1, 2014, will implement stricter oversight of railway companies. As a result, a company that manufactures railroad system or components for domestic use must obtain an approval in accordance with the technical specifications of manufacturer approval. Although Korea had established the legal system in enforcing railway safety, the government wants the companies continue to develop the more improved safety systems until they gain competitive edge on the world class railway manufacturers. This paper presents an in-depth analysis of the technical specifications for manufacturer approval in International Railway Industry Standard (IRIS), which is the global standard. This paper also proposes measures and guidelines that would help Korean manufacturers those who want further develop their safety management systems, as a prerequisite for them to obtain the manufacturer approval.

철도안전법의 제작자 승인에 대한 철도업체의 대응 방안

이환덕(Hwan-Deok Lee),정원(Won Jung) 한국신뢰성학회 2014 한국신뢰성학회 학술대회논문집 Vol.2014 No.11

Recently, Germany, India, Russia, France, USA, Spain, etc. due to the railway accident that occurred around the world, the need for enhanced railway safety are among the many railway accidents occurring in the country is being raised. Korea Railway Safety law, as amended in the implementation of the 2012 March 2014 defines the requirements necessary to ensure the railway safety and railway safety laws amended in order to contribute to the promotion of the public welfare by establishing a railway safety management system enforced who want to create a railway vehicle shall be operated in accordance with the domestic producers approved. Provide a legal basis for ensuring railway safety as one of the world"s highest goal was to have the competitive advantage of the advanced railway company in order to continue to develop the safety management system of the railway industry. To remain competitive, review the contents of the authors and approved for domestic production as compared with railways outside world class railway standard IRIS future production of the guide rail companies and domestic producers for the content of the Quality Management System to be provided to the manufacturer approval proposes a plan for the development of a quality management system.

특허권자와 복제약 사업자의 역지불합의에 관한 연구 - 관련 미국판례와 공정거래위원회의 개정 심사지침을 중심으로 -

신혜은 한국지식재산학회 2011 産業財産權 Vol.- No.36

This article relates to study on reverse payment agreement between patent holders and generic drug manufacturers, especially focused on related American cases and revised guideline of Korean Fair Trade Commission. On December 13, 2011, Free Trade Agreement between the Republic of Korea and the United States of America(here in after, refer to as 'Korea-U.S. FTA') was ratified by the House of Representatives and the Senate of USA respectively, therefore, the only thing remained to be in effect of the agreement is ratification of Korean National Assembly. Among Korea-U.S. FTA, the most arguable issue is approval-patent linkage system. The Hatch-Waxman Act established a regulatory framework that sought to balance incentives for continued innovation by research based pharmaceutical companies and opportunities for market entry by generic drug manufacturers. However, because of reverse payment agreement between patent holders and generic drug manufacturers, approval-patent linkage system under Hatch-Waxman Act tend to not work effectively. Then, reverse payment agreement between patent holders and generic drug manufacturers are against Antitrust Law? We don't have any case about that question, but the courts of United States have lots of cases as to that question. For example, one court of appeals found that kind of agreement to constitute a per se antitrust violation. Other courts have found that kind of agreement to be legal, in part based on the reason that agreement as to patent fell within the patentees' exclusionary right. In this article, I set forth my thoughts on how to balance the role of Antitrust Law and the patent property right given to patentee by Patent Law, and suggested the way to practice 'approval-patent linkage system' more effectively in Korea without the same trial and error in States through studying of related American cases.

항공기 부품제작자증명 인증절차에 관한 고찰

이강이(Kang-Yi Lee),이백준(Baeck-Jun Yi),정하걸(Ha-Girl Chung),유창경(Chang-Kyung Ryoo) 한국항공우주학회 2014 韓國航空宇宙學會誌 Vol.42 No.12

항공기 부품은 새로 개발되는 항공기의 설계를 구성하는 일부일 뿐만 아니라, 형식증명을 받은 항공기의 감항성을 유지하는데 중요한 역할을 한다. 미국은 1965년부터 부품제작자승인 제도를 수립·시행하여 운용 중인 항공기의 감항성 유지는 물론 전 세계의 항공기 부품 시장의 확대에 기여해 왔다. 본 논문에서는 미국의 부품제작자승인, 유럽의 유럽부품 승인, 그리고 우리나라의 부품등제작자증명 제도를 상호 비교 분석함으로써 국제적 안전성 기준에 부합하고 부품산업 발전에 기여할 수 있도록 개선사항을 제시하였다. Aircraft parts are considered as a significant element for the continued airworthiness of the certified aircraft well as a partial component consisting of the new aircraft design. US FAA established the certification system of Parts Manufacturer Approval in 1965, which is contributing to the continued airworthiness of the aircraft in operation and to the expansion of worldwide market of aircraft parts. In this paper, we compared the differences of the certification systems between FAA Parts Manufacturer Approval and EASA European Part Approval, and proposed the rulemaking items to improve Korean Parts Manufacturer Certification System and to contribute to growth of aircraft parts industry.

부품승인(PMA/EPA) 제도와 항공부품시장 동향

정봉구(Jeong,gBong-Gu),진영권(JINNYoung-Kwon) 한국항공우주연구원 2009 항공우주산업기술동향 Vol.7 No.2

그 동안 항공부품시장은 높은 신뢰성과 안전성을 요구하는 항공산업의 특성로 인해 OEM(Original Equipment Manufacturer) 부품이 주도하여 왔다. 그러나 제조기술의 발전, 경기침체, 유가상승 및 아시아-태평양 신흥 시장의 부각 등의 환경적 변화로 인해, 최근, 항공시장에서의 PMA 부품에 대한 관심이 지속적으로 증대되고 있다. 실제로 2006년 이후 FAA PMA 승인부품은 매년 40,000 개씩 증가하고 있으며, PMA 부품 보급률(아시아-태평양 시장)은 2007년 2.5%에서 2017년 8%까지 증대될 것으로 예상되고 있다. 따라서, 본 논문에서는 항공부품 승인제도에 대한 이해를 도모하고, 새로운 PMA 시장을 살펴보기 위해 FAA PMA/EASA EPA의 절차상 요건과 PMA 부품시장 현황을 소개하였다. Until now, The Market of aviation parts had led by OEM(Original Equipment Manufacturer) parts because of aviation industry's nature required higher reliability and safety. But recently, The interest about PMA parts in aviation market is increasing continuously with various environmental changes, such as economic stagnation, oil price rise, development of the manufacture technique and newly rising market of Asia-Pacific region. Actually, after 2006, FAA PMA approval parts are increasing at a rate of around 40,000 parts per year and 2.5% of PMA parts penetration, in 2007, in Asia-Pacific market is forecast to enlarge up to 8% in 2017. So, this paper introduces the process requirements of FAA PMA / EASA EPA and the status of PMA market in order to enhance understanding for certification for aviation parts and to review a new PMA market.

국내외 품질관리체계 기준 비교를 통한 철도차량 제작자승인 기술기준 분석 연구

이석우(Sukwoo Lee),김상헌(Sanghun Kim),박진규(Jinkyu Park),강지성(Jisung Kang),김연수(Yeonsu Kim) 한국철도학회 2015 한국철도학회 학술발표대회논문집 Vol.2015 No.5

부품등제작자증명(PMA) 제도에 관한 연구

정봉구,Jeong, Bonggu 항공우주시스템공학회 2012 항공우주시스템공학회지 Vol.6 No.3

Until now, The Market of aviation parts had led by OEM(Original Equipment Manufacturer) parts because of aviation industry's nature required higher reliability and safety. But recently, The interest about PMA parts in aviation market is increasing continuously with various environmental changes, such as economic stagnation, oil price rise, development of the manufacture technique and newly rising market of Asia-Pacific region. So, this paper introduces the trend and the requirements of FAA PMA / EASA EPA in order to enhance understanding for certification for aviation parts.

의약품 판매허가를 위한 특허발명의 시험적 실시행위와 특허권의 침해

신혜은 ( Hye Eun Shin ) 한국지식재산연구원 2008 지식재산연구 Vol.3 No.2

This thesis is related on experimental use of pharmaceutical patent for approval of generic drug and infringement of the patent. Pharmaceutical industry is very unique compared with other industries. Pharmaceutical drug products need considerable time to obtain approval of sales due to confirmation of effectiveness and safety. Therefore, the Korean patent law was revised in 1986 that the term of the pharmaceutical patent right may be extended during which the patented invention could not have been worked for completing the activity test, safety tests and so on. However, the question of whether the experimental use of pharmaceutical patent for approval of generic drug is allowable is still remained. This question should be answered based on the balance of incentives for research-based pharmaceutical companies(prior patentees), generic drug manufacturers and the drug consumers.

수송류 항공기용 금속계 제동패드의 역설계 절차

김민지,김경일,김경택 한국항행학회 2023 韓國航行學會論文誌 Vol.27 No.5

본 연구는 항공기용 부품 및 장비품 중 치명성 부품인 수송류 항공기용 금속계 제동패드의 부품등제작자증명 및 부가형식증명을 위한 원 부품 등과 개발품의 설계 동일성 입증을 위한 역설계 절차를 도출하였다. 역설계 절차에 대한 규정은 우리나라의 경우 부품등제작자증명 지침에 의해 규정되며, 미국의 경우 AC No; 21.303-4에 규정되어 있다. 제동패드의 역설계 절차는 각 구성품별 샘플 수량, 치수공차, 기계적 물성 측정, 자재, 무게 및 부피특성 등의 동일성 확인 항목을 선정하여 각각의 세부 절차를 정의하였다. 아울러 우리나라 및 미국의 연방항공규정을 분석한 결과, 우리나라의 경우 수송류 항공기용 제동장치의 기술표준품 표준서 및 비행시험과 관련된 규정의 제정이 필요하다. This study derived a reverse engineering procedure for verifying the design identity of original parts and developed parts for PMA(Parts Manufacturer Approval) and STC(Supplemental Type Certificate) of metal brake pads for transport aircraft, which are critical parts among aircraft parts and equipment. In Korea, the regulations for reverse engineering procedures are regulated by the Parts Manufacturer Approval Guidelines, and in the United States, AC No. 21. 303-4. In the reverse engineering for the brake pad, the detailed procedures for each component were determined by selecting verification test items to confirm identity based on sample quantity, dimensional tolerance, mechanical property measurement, material, weight and volume characteristics for each component. In addition, as a result of analyzing the regulation of Korea and United States, in the case of Korea, it is necessary to establish technical standards for braking systems for transport aircraft and regulations related to flight tests.

철도안전법의 제작자 승인을 위한 정량적 평가 모형 개발

김학술 ( Hak Sul Kim ),김상부 ( Sang Boo Kim ) 한국품질경영학회 2016 한국품질경영학회 학술대회 Vol.2016 No.2