Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Cytotoxicity Evaluation on Hydrogels for Medical Devices based on the International Organization for Standardization

국제표준화기구 기준에 의한 의료기기용 하이드로겔의 세포독성 평가

  • 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)
  • 김현기 (충남대학교 약학대학) ;
  • 김예태 (충남대학교 약학대학) ;
  • 조양하 (식품의약품안전청 의료기기 기준과) ;
  • 노혜원 (식품의약품안전청 의료기기 기준과) ;
  • 김민아 (식품의약품안전청 의료기기 기준과) ;
  • 김소연 (충남대학교 공과대학) ;
  • 허강무 (충남대학교 공과대학) ;
  • 박정숙 (충남대학교 약학대학)
  • Published : 2009.04.27
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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.

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References

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