Abstract ▼

This study was conducted to prepare guidelines for safety performance evaluation of intravascular energy catheter and epidural catheter.

Investigating the technology development and commercialization trends of intravascular energy using catheter and epidural catheter, product research and app

This study was conducted to prepare guidelines for safety performance evaluation of intravascular energy catheter and epidural catheter.

Investigating the technology development and commercialization trends of intravascular energy using catheter and epidural catheter, product research and application technology classification, domestic and international standards, guidance, item classification and permission status survey analysis, and individual product characteristics were investigated and safety and performance evaluation method was developed.

As for the intravascular catheter that uses energy, a method of reclassifying items according to the purpose of use of the catheter (diagnosis, treatment, application site, etc.) was proposed, and an item classification plan was developed.

The above research results are the safety and performance evaluation guideline for epidural catheter and energy-using intravascular catheter to secure safety, scientific evaluation method, and secure competitiveness to ensure rapid licensing and safety for relevant permit review, and permit review guide for civil petitioners and reviewers. It is believed that the line was prepared.

[Development of guidelines for evaluating safety performance of epidural catheter]
A. Research on technology development and the market of epidural catheter technology trends
B. Domestic and foreign related standards, guidance, and research analysis
C. Development of safety and performance evaluation methods for each performance of a stterability, balloon dilatation, drug injection function, and a video module-mounted epidural catheter
D. Evaluation of safety and performance of epidural catheter and development of guidelines for approval review
-Proposal 15 items of stability and performance evaluation guidelines
-Review the adequacy of the guidelines through an advisory group
-Development new guidelines based on ISO 10555-1,4 ISO 8600-1,3 and IEC60601 standards
-Supplement with guidelines suitable for procedures using an epidural catheter

(source : Summary 10p)

목차 Contents

• 표지 ... 1
• 최종보고서 ... 2
• 제 출 문 ... 4
• 목차 ... 5
• Ⅰ. 총괄연구개발과제 요약문 ... 8
• 국문 요약문 ... 8
• Summary ... 10
• Ⅱ. 총괄연구개발과제 연구결과 ... 13
• 제1장 총괄연구개발과제의 목적 및 필요성 ... 13
• 제2장 총괄연구개발과제의 내용 및 방법 ... 20
• 제3장 총괄연구개발과제의 최종결과 및 고찰 ... 24
• 제4장 총괄연구개발과제의 연구성과 ... 37
• 제5장 총괄주요연구 변경사항 ... 38
• 제6장 총괄참고문헌 ... 38
• 제7장 총괄첨부서류 ... 38
• Ⅲ. 제(1)세부연구개발과제 연구결과 ... 39
• 제1장 제(1)세부 연구개발과제 요약문 ... 40
• 제2장 세부연구개발과제의 목적 ... 42
• 제3장 세부연구개발과제의 내용 및 방법 ... 48
• 제4장 세부연구개발과제의 결과 및 고찰 ... 56
• 제5장 세부참고문헌 ... 176
• Ⅲ. 제(2)세부연구개발과제 연구결과 ... 178
• 제(2)세부 연구개발과제 요약문 ... 179
• 제2장 세부연구개발과제의 목적 ... 182
• 제3장 세부연구개발과제의 내용 및 방법 ... 184
• 제4장 세부연구개발과제의 결과 및 고찰 ... 241
• 제5장 세부참고문헌 ... 243
• 끝페이지 ... 245