Koo Tae-Hoon, Lee Jason K, Grogan Shawn P, D'Lima Darryl D
D.med LLC, 111, Sagimakgol-ro, Jungwon-gu, Seongnam-si 13202, Gyeonggi-do, Republic of Korea.
Shiley Center for Orthopaedic Research and Education at Scripps Clinic, 3550 John Hopkins Ct, Suite 110, San Diego, CA 92121, USA.
J Funct Biomater. 2025 Sep 15;16(9):347. doi: 10.3390/jfb16090347.
Biocompatibility evaluation of medical devices is essential for ensuring safety, with ISO 10993 series being the standard. However, these tests can be time-consuming and resource-intensive. This study assessed the early-stage biocompatibility of a collagen matrix derived from porcine dermis using three selective ISO tests: in vitro cytotoxicity, in vivo sensitization, and irritation. Collagen was hydrolyzed, purified from miniature pig skin, and then processed into porous sheets via lyophilization. Extracts were prepared using both polar and non-polar extraction vehicles for biological testing. Cytotoxicity testing with mouse fibroblast cells showed no significant cytotoxic effects, with cell morphology and viability comparable to controls. Sensitization testing in guinea pigs, involving intradermal and topical exposure, revealed no allergic responses. Irritation testing in rabbits showed no signs of irritation. The cytotoxicity test took 3 days, the sensitization test 28 days, and the irritation test 7 days, all of which proved suitable for early biocompatibility screening. These results confirmed that the collagen matrix is non-cytotoxic, non-sensitizing, and non-irritant for a month. The use of these three tests enables early identification of unsafe materials, reducing time, cost, and animal use before advancing to more complex ISO 10993 studies. Therefore, they are appropriate and necessary for early feasibility decisions in medical device development.
医疗器械的生物相容性评估对于确保安全性至关重要，ISO 10993系列是该标准。然而，这些测试可能既耗时又耗费资源。本研究使用三项选择性ISO测试评估了源自猪真皮的胶原蛋白基质的早期生物相容性：体外细胞毒性、体内致敏性和刺激性。胶原蛋白经水解后从微型猪皮肤中纯化出来，然后通过冻干加工成多孔片材。使用极性和非极性提取媒介物制备提取物用于生物学测试。对小鼠成纤维细胞进行的细胞毒性测试显示无明显细胞毒性作用，细胞形态和活力与对照相当。在豚鼠中进行的致敏性测试，包括皮内和局部暴露，未显示过敏反应。在兔子中进行的刺激性测试未显示刺激迹象。细胞毒性测试耗时3天，致敏性测试耗时28天，刺激性测试耗时7天，所有这些都证明适用于早期生物相容性筛选。这些结果证实，该胶原蛋白基质在一个月内无细胞毒性、无致敏性且无刺激性。使用这三项测试能够在进入更复杂的ISO 10993研究之前尽早识别不安全材料，从而减少时间、成本和动物使用量。因此，它们对于医疗器械开发中的早期可行性决策是合适且必要的。
