• Title/Summary/Keyword: Approval standard

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A Study on Certification Procedures for Technical Standard Order Authorization of USA and Europe (미국과 유럽의 항공기 기술표준품 인증절차에 관한 고찰)

  • Lee, Kang-Yi;Park, Guen-Young;Chung, Ha-Girl;Ryoo, Chang-Kyung
    • Journal of Aerospace System Engineering
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    • v.9 no.1
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    • pp.19-27
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    • 2015
  • The Technical Standard Order articles are the parts and appliances for which the civil aviation authority designates as it is necessary to standardize for the expedited certification process and aviation safety. TSO articles were used on the type certified aircraft as replacement parts in the early days of TSO authorization system, but those articles are widely used on the newly developed aircraft as well in these days. In this paper, we compared the differences of the TSO authorization systems between FAA and EASA, and proposed the rulemaking items to improve Korean TSO authorization system and to contribute to growth of aviation industry.

Enhanced Standardization Process and Reform Discussions in ITU-T (ITU의 정보통신표준화 절차 개선과 개혁 논의)

  • Sohn, Hong;Song, Gi-Pyeung;Park, Ki-Shik
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2001.05a
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    • pp.532-536
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    • 2001
  • In responding to rapid technological change, ITU standardization activities is changing. For example, ITU-T has established new approval process for technical Recommendations, named Alternative Approval Process. This process shortens standard approval period form 9 months to 2 months. In this paper, we analyze the new approval process, AAP, step by step. And finally, we discuss .ITU reform issues such as decision making right of private industry organizations which is ongoing.

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A Study on the Certification Criteria fot Personal Watercraft Using Electric Power Propulsion (전기 동력 추진식 수상오토바이 인증기준 개발 연구)

  • Kang, Dae-Kon;Kim, Shin-Hyo
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.23 no.1
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    • pp.67-72
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    • 2017
  • This study developed an electric power propulsion personal watercraft by combining a battery and an electric system from the domestic automobile industry with water motorcycle from marine leisure industry in a convergence of technology. It also developed a safety inspection plan and type approval standard for personal watercraft that use electric power propulsion. For the registration and production of the electric power PWC (Personal Watercraft), a safety inspection standard (draft) and type approval standard (draft) have been established. PWC that use this electric power propulsion certification standard have been divided into two categories according to the use of gasoline engines as related to the ship's electrical system. The contents of these safety inspections standards is divided into 7 categories, and their purpose is to confirm the facilities used for the safe operation of PWC. Type approval is divided into 7 categories and is intended to ensure the safe production of PWC. This is basic data can be used to establish criteria for safety inspection and type approval of electric power propulsion vessels and to guide the production of the environmentally friendly PWC in Korea.

Comparison of Airworthiness Certification System between Korea and U.S. (국내 항공인증과 미국 인증체계의 비교)

  • Hong, Deok-Kon;Yee, Kwan-Jung
    • Journal of the Korean Society for Aeronautical & Space Sciences
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    • v.36 no.3
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    • pp.298-305
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    • 2008
  • From design to serial production, aircraft should go thorough complicated certification procedure from airworthiness authority such as Type Certificate, Production Certificate and Certificate of Airworthiness. On the other hand, aircraft components are mandated to receive Technical Standard Order Approval and Production Manufacture Approval before commercial use. As domestic aircraft and LRUs are currently under development, Bilateral Aviation Safety Agreement is promoted for the purpose of increasing aviation safety as well as foreign export. This paper describes the basic aircraft certification procedure and compares the difference in the certification system of US and Korea. Thorough this, it is attempted to suggest a requirements for establishing international certification system.

TSO Authorization of Airborne Multipurpose Electronic Displays (항공기용 다목적 디스플레이의 기술표준품 인증)

  • Cheon, Young-Ho;Lee, Seoung-Pil;Park, Jun-Hyeon
    • Journal of Advanced Navigation Technology
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    • v.17 no.6
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    • pp.765-776
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    • 2013
  • Civilian aircraft industry, even if the superior performance of the product in order to ensure the safety of aircraft navigation safety requirements necessary for compliance does not receive a legally recognized can not be used in aircraft characteristics. These are applied in a variety of safety in avionics for navigation of civil aircraft certification standards for the technology is implemented. KTSO-C113 aircraft for the purpose of electronic display technology to authenticate standard contains minimum performance standards. Standard design and manufacturing technology for type approval means approval by mounting the aircraft in order to use a separate approval is required. Through this paper, multi-display technology standards for aircraft type certification approval system and demonstrate compliance with the requirements for the certification practices introduced are presented.

GOOD LABORATORY PRACTICE -PRINCIPLES AND PRESENT STATUS IN JAPAN

  • Omori, Yoshihito
    • Toxicological Research
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    • v.1 no.1
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    • pp.31-41
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    • 1985
  • The Japanese Good Laboratory Practice (GLP) Standard on Drugs was finalized as a guideline and implemented in April, 1983. This standard is intended to ensure the quality and integrity of the data from nonclinical toxicity studies submitted to the Ministry of Health and Welfare in support of applications for approval to manufacture or import new drugs or to be used in the reevaluation of previously approved drugs. The standard includes a guideline for organizational matters, personnel, facility, equipment, testing operation, documentation and conduct of studies. Principles and influences of implementation of Japanese GLP will be discussed briefly in comparison with foreign GLPs.

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A Study on Parts Manufacturer Approval in Civil Aviation Law (항공기 부품제작자증명에 관한 연구)

  • Lee, Kang-Yi;Jin, Young-Kwon;Lee, Jong-Hee;Lee, Kwang-Hee
    • The Korean Journal of Air & Space Law and Policy
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    • v.17
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    • pp.133-152
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    • 2003
  • Certification by Civil Aviation Law is necessary for aircraft parts and appliances as well as aircraft, engines, and propellers to ensure safety and reliability in operation. Advanced countries in aerospace industry as like U.S.A require Parts Manufacturer Approval for aircraft parts and Technical Standard Order Authorization for designated appliances. However, there are no legal requirements for certification of aircraft parts and appliances in Korea until now. This study presents the draft to revise Civil Aviation Law, which is applicable to set up domestic certification system and maintain it equivalent to U.S. Federal Aviation Regulation.

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A Study on Authorization Procedure of Digital Textbooks (디지털교과서 검인정 방법에 관한 연구)

  • Park, Yong Hun;Lee, Seok Jae;Yoo, Jae Soo;Yoo, Kwan Hee;Lee, Tae Won
    • Proceedings of the Korea Contents Association Conference
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    • 2007.11a
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    • pp.799-803
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    • 2007
  • In this paper, we research into an effective operation environment of digital textbook according to the adaption of an electronic textbook and analyze the approval program and the authorization program of the paper textbook for the efficient utility of a digital textbook. We propose various criterions and methods of the approval and authorization program. Finally, we show the whole process of the proposed approval and authorization program. We hope that our study apply to the standard approval and authorization program of the Ministry of Education.

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A Study on the Changes in Regulations Regarding Approval, Notification and Review of Herbal Medicinal Preparations and Crude Drug Preparations - From 1948 to 2012 - (한약・생약제제 품목허가신고심사 규정 변화에 관한 고찰 - 건국이후부터 2012년까지 -)

  • Eom, Seok-Ki
    • The Journal of Korean Medical History
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    • v.27 no.2
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    • pp.11-37
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    • 2014
  • Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.