1. Biological Effect: Physical and/or Chemical information / In Silico Tests
2. Turnaround time: 4 weeks
Complete toxicological risk assessment of a medical device usually involves two steps. During the first one, data is gathered using chromatographic methods according to the ISO 10993-18. In the second step, all identified compounds during extractable/leachable study are evaluated for potential hazards. The procedure involves extensive evaluation of toxicological data related to each identified compound. However, in many cases, the available toxicological data is insufficient. In this case, the compound’s toxicity is predicted using in silico modeling and appropriate software. Then, based on the type of compound, allowable exposure limits, and other factors, each tested compound’s Margin of Safety (MOS) is derived. European Biomedical Institute provides a toxicological risk analysis either as a separate service or as a part of chemical studies.