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이해광,유규하,조양하,노혜원,박해대,이창형,정호년,양원선,김정구 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
조직긍학은 의학 연구 분야에서 활발한 성장을 보이핀 있늘 분야로 떠오르고 있다. 이러한 조직공f·? 제푿들 대다수는 자연적이거나 생체재료와 조합된 니포구성 성력의 이용에 의존하고 있다. 하지만 쵤근 들어 인공피부, 인긍연골 등 조직긍학 계품이 급슥히 상품화되어 출시될 단계에 있으나 이fl 퍼한 안전성과 유효성 평가피준은 아직 정린되지 못하초 있는 상채이다. 이에 본 연구에서는 믿을만한 의학적 산둘로서 자리 매깅 할 인공연골을-비릇한 조픽공학 재품을 사람에 적용함에 있어 이에 대:한 안전 성쏙 성능 평가를 위한 일반적인 접근을 시도곯였다. 쪼직공학 재품의 쵱가기법과 관련된 제품의 개발 과정베서 반드시 고려리어야 할 분야에 대하여 기쑨하있다. 이에 대한 사항은 다음과 같아 요약될 수 있다 : 1) 세포 및 조직의 유래 ?) 세포 딪 조직의 특서 3; 싱페재료 f,1험 4) 품질보증 5) 픔질관리 6) 비인상 딪 7) 꼴상 펼가가 이엑 해당된다. 로글 코픽공착 제픔 가운데 세포의 유래에 차하여 콩속꼭친 분야왁 독린적인 분야호 영역을 분리하였다. 첫 1,4Fil 길우는 T·11룸의 작용기작이 진체의 극뚜건 부위엑서 구즈쓱 기논의 수복이나 재건을 목적으로 사욧쓴:=7 겄이. 투 껀째 경우는 711품의 작응기각이 진신적으로꺼 껑리학적이나 약리학적으로 활성들 나니내글- 게붐이다. 일반적으초 조직공학 제품의 안진겊곽 성늘 편가를 워한 기법의 개발은 장대적으로 오랜 기간 동안 찬자에게 이식되는 제품에 초점이 딱추어꼭 것이며, 본쳔케서는 제 1단계 사업으로꺼 현Rf 상품화 단끼에 있는 인공연골을 중심으로 안전성쓱 껑능에 패글 기적적인 가이드라인을 )If시하핀자 곡다. 이는 관련 재품의 개발에 도음이 될 것이라 믿는다. Tissue Engineering is a very promising field in biomedical research and development. Guidance of tissue engineered medical devices(TEMDs) is very important for the patients' safety and national welfare. Most of TEMDs consist of natural and/or biomedical polymers and polymer- cell/tissue component mixture. Some TEMDs like artificial skin and cartilage are in the stage of commercialization, however, the evaluation standards and testing methods are not prepared yet. In this study, we have developed a guidance for the function, biocompatibility and safety tests of tissue-engineered cartilage. The guidance contains the essential checking ponits in the development process of TEMDs, which are as follow ; 1) cell or tissue origin 2) cell or tissue characteristics 3) biomaterial test 4) quality assurance 5) quality control 6) non-clinical evaluation 7) clinical evaluation. TEMDs were divided into two categories according to the cell origin. The first category contains the devices used for repair and reconstruction of structural function of impaired tissues. The other category contains the systemic devices with physiological and pharmacological activity. Generally, the guideline for function and safety of TEMDs would be focused on the long-term implants. We believe that adoption of thes guidance of tissue-engineered cartilage sould lead to the products consistent in quality and performance as well as safety.
박상민,유규하 대한의용생체공학회 2023 의공학회지 Vol.44 No.1
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 pro- cess 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.
뎁스카메라와 YOLOAddSeg 알고리즘을 이용한 방사선치료환자 미세동작인식 및 실시간 위치보정기술 개발
박기용,유규하 대한의용생체공학회 2023 의공학회지 Vol.44 No.2
The development of AI systems for radiation therapy is important to improve the accuracy, effectiveness, and safety of cancer treatment. The current system has the disadvantage of monitoring patients using CCTV, which can cause errors and mistakes in the treatment process, which can lead to misalignment of radiation. Developed the PMRP system, an AI automation system that uses depth cameras to measure patient's fine movements, segment patient's body into parts, align Z values of depth cameras with Z values, and transmit measured feedback to posi- tioning devices in real time, monitoring errors and treatments. The need for such a system began because the CCTV visual monitoring system could not detect fine movements, Z-direction movements, and body part movements, hin- dering improvement of radiation therapy performance and increasing the risk of side effects in normal tissues. This study could provide the development of a field of radiotherapy that lags in many parts of the world, along with the economic and social importance of developing an independent platform for radiotherapy devices. This study verified its effectiveness and efficiency with data through phantom experiments, and future studies aim to help improve treat- ment performance by improving the posture correction mechanism and correcting left and right up and down move- ments in real time.