Is It Possible To Use The Same Raw Materials As Those Of The Final Product For Biocompatibility Test?

The biological evaluation of product should consider the materials used in the manufacture of the product, intended additives, process contaminants and residues, leachable substances, degradation products, physical properties of the final product, the individual components and their interactions in the final product, packaging materials and the influence of the preservation medium on biocompatibility as well as other factors, so the biocompatibility test of the product should in principle be carried out on the final product, or on the representative samples taken from the final product. If it is not feasible to use the final product for testing, it may be considered to use the specimens produced with the same processes as the final product for testing, but the representatives of the specimens needs to be fully analyzed and demonstrated.