|
KMID : 1142220140090020071
|
|
Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.71 ~ p.77
|
|
|
A Study on Development of a Guideline for Performance Evaluation of Catheter Introducers
|
|
Lee Chong-Ju
Lee Chang-Hyung
Hwang Sun-Jin
Lee Hui-Sung
Heo Ji-Yeon
Park Nam-Jung
Kang Shin-Jung
Kim Hyeog-Ju
|
|
|
Abstract
|
|
|
|
Catheter introducer is a medical device minimizing blood vessel damages that can occur during catheter insertion and promoting the ease of treatment, and is generally used in combination with sheaths, dilators, and guide wires. Having direct contact with skin and blood, this medical device should have satisfactory biocompatibility as well as adequate performance ensuring lower vascular resistance during insertion. Consequently, evaluation criteria and methods need to be prepared for more objective and scientific evaluation of diverse types of catheter introducer. This study is intended to prepare a guideline to assess performance of catheter introducers through investigation and analyses of developmental trends, domestic permission matters, and domestic and overseas standards and guidelines of catheter introducers. The guidelines is expected to contribute to the quality improvement of the relevant industries, export competitiveness of domestic medical devices, and improvement of public confidence through the provision of scientific evaluation methods that meet international standards and necessary technological information for development.
|
|
|
KEYWORD
|
|
|
catheter introducer, dilator, performance, evaluation, guideline
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|