The analysis of hydrogels in accordance with the ISO 10993 series of standards is used for risk assessment and to demonstrate biocompatibility for medical applications. The focus is on chemical characterization, the detection of toxic substances, and biological compatibility.
At the NMI, we characterize your hydrogels for regenerative medicine (based on ASTM F2900) and 3D bioprinting (based on VDI 5708). To this end, we offer the following qualitative and quantitative tests.
Chemical Identity, based on ISO 10993-18
Concentration Determination
Molecular Weight Distribution
Flow Properties
Printability according to VDI 5708
Mass Transport
Diffusion of Nutrients and Waste Products
Release Rate of Biologically Active Substances
Cell Migration
Mechanical Properties
Cell Encapsulation
Environmental Stability, Material Characterization
Diffusion of Nutrients and Waste Products
Release Rate of Biologically Active Substances
Cell Migration
Kinetics
Gelling Time
Swelling Behavior
Matrix Degradation, based on ISO 10993-13
In vitro cytotoxicity, based on ISO 10993-5
Pyrogenicity, according to Ph. Eur. 2.6.14
Antibacterial efficacy, based on ISO 22196 and ISO 20743
Immune response to biomaterials
Additional
3D cell distribution
3D cell morphology
Cell type-specific staining
Cell viability (microscopic / quantitative)