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Recently, biodegradable biomaterials have been widely studied for human tissue or organ replacement therapy. Glass ceramics are candidate materials as they possess bioactivity and biodegradability. This study was carried out to evaluate biological safety of Bonglass-CS, a bone replacement material, according to the Guideline for Safety Evaluation of Medical Device issued by Korea Food and Drug Administration (KFDA) and ISO guideline. We performed various biological safety tests as follows; in vitro tests such as cytotoxicity, hemolysis and genotoxicity tests and in vivo tests including guinea pig maximization test for delayed hypersensitivity, intradermal reactivity, pyrogenicity and acute systemic toxicity tests. In cytotoxicity test, cytolysis was not observed. And the percent hemolysis was 0.224%. In GPMT, none of the guinea pig showed skin erythema, eschar or edema. None of the albino rabbit showed skin erythema, eschar or edema in intradermal reactivity test. In acute systemic toxicity test, there was no sign of toxicity. No temperature increase was observed in rabbits in pyrogenicity test. Genotoxicity study has no potential toxicity under Ames test, chromosome aberration test and sisterchromatid exchange test. In conclusion, no test article-related toxicity was observed at any in vitro and in vivo biological safety tests in the present investigation. Newly developed Bonglass-CS, a bone replacement material, is considered not to be toxic under the test conditions.

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UCI(KEPA) : I410-ECN-0101-2009-510-015707015