Medical technology applications are subject to particularly strict regulations and requirements. Our system for Additive Manufacturing includes qualified machines according to ISO13485:2016 including IQ & OQ as well as materials tested and certified on the machine.
We thus offer solutions explicitly for medical technology that have been tested or evaluated for biocompatibility in accordance with standard ISO 10993-1, -4, -5, -18. These fulfill the specified requirements for contact of up to 24 hours with skin and tissue and, if necessary, indirect contact with blood. The following tests for biocompatibility are usually performed on the 3D-printed part.
- Cytotoxicity / growth inhibition (ISO 10993-5)
- Haemolysis (ISO 10993-4)
- Chemical analysis / fingerprinting (ISO 10993-18)
- Biotoxicological evaluation (ISO 10993-1)