Earticle

초록

영어

Advancements in 3D printing technology have facilitated the development of implantable medical devices capable of replacing damaged human tissues. These devices are primarily fabricated from synthetic polymers with biocompatible and biodegradable properties. In particular, biodegradable polymers require appropriate degradation rates that match the pace of tissue regeneration, making performance evaluation under conditions similar to the human body essential. In this study, we developed a testing method to assess the performance of 3D-printed absorbable barrier membrane fabricated from polycaprolactone. Human biomimetic conditions were simulated using artificial saliva and phosphate-buffered saline, and the changes in performance before and after exposure were evaluated. Domestic and international standards and guidelines were analyzed to determine relevant test items and procedures, and the reliability of the proposed evaluation method was verified through validation tests. The results showed no observable changes in appearance, while the changes in dimensional and porosity characteristics were not statistically significant. In contrast, decreases in mass and molecular weight were observed, and tensile strength showed a substantial reduction, with all three parameters exhibiting statistically significant changes. These findings indicate that performance degradation is more closely associated with the reduction in molecular weight and the resulting decrease in mechanical strength than with changes in appearance. Based on these results, the study highlights the necessity of evaluating biodegradable implantable medical devices under conditions that simulate the implantation environment, and it is expected to contribute to enhancing the reliability of performance evaluation for future devices.

목차

Abstract
I. 서론
II. 연구방법
1. 3D 프린팅 생분해성 이식형 의료기기 현황 및 연구대상 의료기기
2. 인체 이식 환경을 고려한 모사 환경 구축
3. 흡수성 치주조직 재생 유도재 성능평가 시험항목 및시험방법 개발
4. 흡수성 치주조직 재생 유도재 제작
5. 흡수성 치주조직 재생 유도재 모사 환경 침적 용액 설정
6. 흡수성 치주조직 재생 유도재 모사 환경 노출 기간 설정
III. 연구결과 및 고찰
1. 외형
2. 치수
3. 기공률
4. 질량
5. 분자량
6. 인장하중
IV. 결론
감사의 말씀
참고문헌

키워드

저자

• 정지희 [ Ji-Hee Jeong | 식품의약품안전평가원 의료제품연구부 의료기기연구과 ]
• 성연국 [ Yeon-Guk Seong | 식품의약품안전평가원 의료제품연구부 의료기기연구과 ]
• 엄준호 [ Joon-Ho Eom | 식품의약품안전평가원 의료제품연구부 의료기기연구과 ]
• 이응태 [ Eung-Tae Lee | 식품의약품안전평가원 의료제품연구부 의료기기연구과/서울대학교 바이오시스템공학과 ] 교신저자

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2025

• 십진분류

  KDC 518 DDC 615