• The Journal of Korea Institute of Information, Electronics, and Communication Technology
• /
• v.17 no.5
• /
• pp.389-395
• /
• 2024

This study was conducted to determine the cytotoxicity of the extracts from the human body contact area of the test substance during a test on the Good Laboratory Practice (GLP), which is the medical device safety evaluation standard, using the extracorporeal shock wave therapy (ESWT) cartridge as a sample, using L-929 cells. The test and control substances were extracted with 1xMEM culture medium containing 10% FBS at 37±1℃ for 24±2 hours. The test substance extract (test group), negative control substance extract (negative control group), positive control substance extract (positive control group), and blank test solution extract (solvent control group) were applied to L929 cells and cultured for 48±2 hours in a 37±1℃, 5±1% CO2 incubator. As a result of observing cell reactions under a microscope, the cells to which the blank test solution extract and negative control substance extract were applied were grade 0, the cells to which the positive control substance extract was applied were grade 4, and the cells to which the test substance extract was applied were grade 0. As a result of quantitative evaluation through cell counting, the cell viability rate of the cells to which the negative control substance extract was applied was 106.28% compared to the blank test solution extract, the cells to which the positive control substance extract was applied were 0.00%, and the cells to which the test substance extract was applied were 99.58%. Therefore, when the results of the negative and positive control groups were confirmed, the test process was appropriate, and it was determined that it did not cause cytotoxicity because the qualitative evaluation method was less than grade 2 and the quantitative evaluation method showed a cell viability rate of more than 70%.