Biocompatibility Evaluation of Porcine-Derived Collagen Sheets for Clinical Applications: In Vitro Cytotoxicity, In Vivo Sensitization, and Intracutaneous Reactivity Studies.

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.