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http://dx.doi.org/10.4333/KPS.2009.39.2.127

Cytotoxicity Evaluation on Hydrogels for Medical Devices based on the International Organization for Standardization  

Kim, Hyun-Ki (College of Pharmacy, Chungnam National University)
Kim, Ye-Tae (College of Pharmacy, Chungnam National University)
Cho, Yang-Ha (Medical Device Standardization Division, Korea Food and Drug Administration)
Roh, Hye-Won (Medical Device Standardization Division, Korea Food and Drug Administration)
Kim, Min-A (Medical Device Standardization Division, Korea Food and Drug Administration)
Kim, So-Yeon (College of Engineering, Chungnam National University)
Huh, Kang-Moo (College of Engineering, Chungnam National University)
Park, Jeong-Sook (College of Pharmacy, Chungnam National University)
Publication Information
Journal of Pharmaceutical Investigation / v.39, no.2, 2009 , pp. 127-131 More about this Journal
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.
Keywords
Hydrogel; International Organization for Standardization; Medical devices; Cytotoxicity;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
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