|
KMID : 1142220130080010097
|
|
Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.97 ~ p.102
|
|
|
Development of The Guideline for Performance Evaluation of Wound Dressing
|
|
Hwang Sun-Jin
Ryeom Tai-Kyung
Bang Ji-Young
Heo Ji-Yeon
Lee Chang-Hyung
Lee Byung-Young
Kang Shin-Jung
Kim Hyeog-Ju
|
|
|
Abstract
|
|
|
|
The wound dressing is a medical device coming into direct contact with injured skin, for the purpose of protecting the wound from contamination. Therefore, it has to be biocompatible and able to protect the wound and prevent contamination. Further, it has to be able to absorb exudate and prevent loss of blood or body fluid. At present, various types of wound dressing products are commercially available, including polyurethane foam, sheet and liquid. Accordingly, it is not possible to make specifications that can generally apply to all kinds of such products. Therefore, it is highly necessary to develop guidelines on test items and methods for evaluation of wound dressing products covering various raw materials and product types. To this end, information on regulatory authorization of wound dressing products and R&D trends in Korea and foreign countries was investigated and local and foreign specifications and international standards were collected and comparatively reviewed. In this study, quality specifications that cover various raw materials and wound dressing product types were investigated and developed. The guidelines on performance evaluation of wound dressing products developed in this study may be useful in development and quality control of wound dressing products, ultimately contributing to improved safety and efficacy of wound dressing products.
|
|
|
KEYWORD
|
|
|
Wound dressing, Hydrogel, Collagen, Biological origin, Absorbable
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|