Reference Libraries

Purpose: The aim of this study was to determine if the EpiDerm™ reconstructed human skin model (MatTek Corp.) could be an acceptable alternative to the ISO 10993-required rabbit skin irritation test for assessing medical device biocompatibility. Eleven medical device polymers were... Read More

In accordance with ISO 10993, the rabbit skin irritation test is used to assess medical device biocompatibility, however, this method is time-consuming and expensive.  Our study’s goal was to determine if the EpiDerm™ reconstructed human skin model (MatTek Corp.) could... Read More

In autumn 2007, an international validation study was performed to evaluate the reproducibility and confirm the predictive ability of the EpiDerm Skin Irritation Test (SIT) method (1, 2). In November 2008, ECVAM endorsed the EpiDerm SIT as a full replacement... Read More

Classification and labeling of products with extreme pH values (62 or P11.5) is addressed in chemicals legislation. Following determination of pH and alkaline/acid reserve, additional in vitro tests are needed, especially to substantiate results less than corrosive. However, only limited... Read More