• Title/Summary/Keyword: 의료기기산업

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광학R&D산실 - 초정밀가공 방산기술 국산화로 도약의 기지개 '활짝', 한국전광(주) 부설연구소

  • Park, Ji-Won
    • The Optical Journal
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    • s.126
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    • pp.22-24
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    • 2010
  • 한국전광(주)(대표.채진석, www.keocvi.com)는 코팅전문업체로서 국내보다는 미국, 일본, 독일 등 세계에 먼저 이름을 알리며 고출력레이저광학소자의 가공 및 코팅에서만큼은 이미 세계 최고 대열에 들어섰다고 자부한다. 최근에는 방산, 항공우주, 반도체, 의료기기 등 전방위에 들어가는 고부가가치 광학소자 및 시스템 분야로 사업 영역을 확장시키며 광학부품업체에서 토털솔루션 제작업체로 변신을 추구하고 있는 가운데 부설연구소의 김기호 연구소장을 만나 최근의 연구개발 현황을 들어보았다.

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인터뷰-전 산업자원부 장관 박태영

  • Korea Association for Photonics Industry Development
    • Photonics industry news
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    • s.5
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    • pp.6-7
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    • 2001
  • ‘광산업이란 빛이 가지고 있는 성질을 활용해 각종 첨단제품을 생산 ∙ 판매하는 산업입니다. 자연광을 포함해 다양한 성질의 빛을 만들고, 제어하여 활용하는 것으로서 전통적으로 광학 및 광원(조명기기) 분야에 국한되었으나, 1960년대 레이저가 발명된 이후 광전자, 초정밀 계측, 의료기기 등으로 확장되어 가고 있는 추세입니다’ 21세기 대표산업으로 자리매김할 광산업을 육성하기 위한 정책입안에서부터 예산에 이르기까지 많은 노력을 아끼지 않은 박태영 전 산업자원부장관은 정부 관계자, 광주시, 광산업체, 학계, 연구소 등 광관련 관계자들의 한국광산업발전을 위한 노력을 치하하고 더욱 분발하여 국내 광산업이 2010년까지 세계 5위권에 진입할 수 있도록 노력해 주기를 바라며 ‘본인도 미력하나마 국내 광산업 발전에 혼신의 노력을 다하겠다’라고 밝혔다.

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ISO14971:2019 Detailed Analysis and Periodic Safety Update Report Establishment Method for the Single Use Medical Device - Focusing on Medical Device Regulation 2017/745 requirements (일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 - Medical Device Regulation 2017/745 요구사항 중심으로)

  • Sang Min, Park;Gyu Ha, Ryu
    • Journal of Biomedical Engineering Research
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    • v.44 no.1
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    • pp.1-10
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    • 2023
  • With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

Sludge를 이용한 자기연마재 개발

  • 김희남;윤여권;김희원;하문호;안효중;심재환
    • Proceedings of the Korean Institute of Industrial Safety Conference
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    • 2003.10a
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    • pp.263-269
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    • 2003
  • 최근 반도체 및 식품, 의료기기를 비롯한 기간산업 분야의 고도화에 따라 사용되는 부품의 정밀도뿐만 아니라 청정도를 동시에 요구하는 추세이다. 따라서 기존의 기계적 가공방법으로는 공작물 표면에 미소한 가공흔적이 남게되어 표면의 요철부분에 칩(chip)등의 불순물이 잔재할 우려가 있으며, 또한 요철 부분에 미생물이 번식할 경우 청정도가 떨어져 산업위생상의 문제점이 발생하게된다.(중략)

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Medical Service In Inernet of Things (사물인터넷 환경의 의료서비스)

  • Woo, Sung-hee
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2015.05a
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    • pp.876-879
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    • 2015
  • Inernet of Things(IoT) is a network to be interconnected with things anytime, anywhere. This means interaction with each other, collecting, sharing, and analysing the data. IoT also offers a new paradigm shift in industry. In particular, the combining with the fields of health care services has been noted. The convergence of IoT technology and health care is expected to be the innovation paradigm in the healthcare industry that includes all of the changes to bring the mobile health and wearable health care devices. This study analyzes IoT, health care status, and the use cases of the IoT in the medical field, finally analyses security on the Internet of Things, the most important issues of security challenges while still in medical services.

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레이저 안전관리와 필요성

  • Kim, Yeong-Sik
    • The Optical Journal
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    • s.105
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    • pp.27-29
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    • 2006
  • 레이저 광선이 가져다준 많은 장점과 편리함에 비하면 레이저의 위험성이라는 부정적인 요소가 차지하는 비중은 미미하다고 볼 수 있다. 그러나 우려되는 것은 레이저를 생산하거나 이용하는 공장의 작업장을 비롯하여, 수술 또는 치료용으로 사용하는 의료기관의 수가 지속적으로 늘어나고 있음을 감안할 때, 이러한 장소에서 레이저를 동작시키는 사용자를 포함한 주변사람이 레이저광선에 직접 또는 간접적으로 노출되어 사고를 당할 확률도 그만큼 높아지고 있다는 점이다.

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효과적인 설비관리시스템의 구현기술 동향 분석

  • 차석근
    • ICROS
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    • v.3 no.4
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    • pp.16-19
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    • 1997
  • 효과적인 설비관리 구현의 중요성은 전산업에 적용이 가능한 시스템으로 특히 고가의 설비에 의하여 운영이 되는 발전소, 화학, 철강 등과 같은 장치 산업을 중심 으로 구현되어 왔으나, 국가 기반 시설인 고속전철, 지하철, 항공기 분야와 의료기기를 사용하는 병원에서 안정성을 중심으로 관리 필요성이 강조되며 또한 빌딩의 효율적인 관리를 위한 분야로 확대 적용이 가능하다.

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A Study on the bioactive surface modification of PEEK intervertebral fusion cage using various coating techniques (다양한 코팅 처리에 의한 PEEK 추간체유합보형재의 생체 활성 표면에 관한 연구)

  • Su-Bin Noh;Su-Zy Park;Mun-Hwan Lee
    • Journal of the Korean institute of surface engineering
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    • v.56 no.4
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    • pp.273-282
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    • 2023
  • In this study, the surface of Polyetheretherketone (PEEK) disks was modified to have a hydrophilic surface by applying a coating of Polyethylene glycol (PEG), Hyaluronic acid(HA), and Poly-Dopamine(PDA). The investigation aimed to examine whether the coated surfaces showed enhanced bioactivity for orthopedic applications compared to the pure PEEK. The microstructure, surface characteristics, and wettability of PEEK coated with PEG, HA, and PDA were analyzed using scanning electron microscopy(SEM), FT-IR spectrophotometer, Roughness Measurement System, Micro-Vickers, and Contact angle measurement. The mechanical properties were analyzed using a tensile testing machine, while the MTT assay for cell activity was analyzed using a microplate reader to measure optical density. According to the SEM and FT-IR results, the composition and crystal structure of PEG, HA and PDA coated surface were verified. Also, roughness, hardness, and contact angle were all improved in the coating group compared to the pure PEEK. We checked the HepG2 cell proliferation by using MTT assay on 7th days. In MTT assay results, HepG2 cell proliferation was increased with time, at 7 days, cell viability on discs coated with PDA was significantly higher than pure PEEK, PEG, HA coated group. PDA coated PEEK exhibited the highest surface roughness, hardness, contact angle, and cell activity. The mechanical properties were not affected by the presence of the coating.

Evaluation of Present Status from Health Technology Assessment(HTA) through case analysis in dentistry (치의학분야 사례분석을 통한 신의료기술평가 현황 평가)

  • Son, Gi Tae;Yang, Seung-Min
    • The Journal of the Korean dental association
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    • v.57 no.6
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    • pp.316-324
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    • 2019
  • The new medical technology assessment system has a basic goal of protecting the public's health rights and promoting the development of the new medical technology with safe and effective medical technology that has been scientifically proven. The purpose of this study is to contribute to the activation of the new medical technology evaluation system by analyzing the application cases of the dental field after the implementation of the new medical technology evaluation system and proposing an efficient approach to approach the new medical technology evaluation system. The number of related literature and medical technology evaluation results are not significant in dental applications, the number of cases and the length of follow-up period of the relevant medical technology adopted as the new medical technology was far higher. As the speed of medical technology development increases, medical technology is expected to develop in the dental field as well. To introduce the medical technology to the clinical site, access to the correct direction of evidence is required to collect and objectify data at the medical site in order to prepare a literary basis for the medical technology.

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