|
KMID : 0369820090390020127
|
|
Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 2 p.127 ~ p.131
|
|
|
Cytotoxicity Evaluation on Hydrogels for Medical Devices based on the International Organization for Standardization
|
|
Kim Hyun-Ki
Kim Ye-Tae
Cho Yang-Ha
Roh Hye-Won
Kim Min-A
Huh Kang-Moo
Park Jeong-Sook
|
|
|
Abstract
|
|
|
|
Hydrogels for medical devices such as hydrophilic dressing, moisturizing healing band, hydrophilic intravenous catheter and soft contact lens were evaluated for their cytotoxicity according to the International Organization for Standardization (ISO) procedures. To test indirect cytotoxicity of hydrogel products, dissolution medium and dissolution condition were selected based on the guideline for medical devices. Cytotoxicity was low in all the case of hydrogel products. Soft contact lens showed no significant difference in dissolution between complete medium and saline. Currently, there is no specific guidelineto test hydrogel for medical devices in Korea with consideration of characteristics of hydrogel. Thus, proper method of cytotoxicity evaluation should be selected depending on the characteristics and usages of hydrogels for medical devices.
|
|
|
KEYWORD
|
|
|
Hydrogel, International Organization for Standardization, Medical devices, Cytotoxicity
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|