For the analysis of collageneos materials, tests are established according to ASTM-Standard F 2212 „Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)”. These tests are required for approval of collagenous medical products by a notifyed body.
| • Collagen content | • Purity |
| • Amino acid analysis | • Peptide mapping using SDS-PAGE |
| • Heavy metal content | • Endotoxin content |
| • Total sugar content | • Trypsin resistance |
| • Collagenase resistance | • Denaturation temperature |
| • SEM | • AFM |
| • Fat content | • Viscosity |
| • Tensile strength | • LC-MS/MS |
| • DNA content | • Elastin content |
| • Molecular mass distribution | • Animal species determination |
| • Special analyses on request |
|
