Biological evaluation of medical products

Business Division: Bio- and Medical Technology

Osteoblasts on silicon nitride.
© Fraunhofer IKTS
Osteoblasts on silicon nitride.

Standard Operating Procedures (SOPs) are essential in the development of new patient-specific implants with biofunctionalized material surfaces, for example. This is the only way to assess the biological and immunological safety as well as the functionality of the materials with regard to their respective application in advance.

Fraunhofer IKTS develops innovative in-vitro test methods as well as standardized testing systems. In addition to the biological examination of ceramics and other implant materials analog DIN EN ISO 10993, researchers are working on immunological compatibility tests. The transfer of experimental test approaches to customer-specific, standardized test methods is part of the range of services.

Furthermore, IKTS scientists develop innovative methods for the investigation of the biodegradation of different material classes. They use artificial body fluids in order to depict material changes and aging processes. These are characterized using physico-chemical analysis methods.

Additionally, the IKTS site in Hermsdorf is certified according to ISO:2016 13485 for the research and development in the area of oxide ceramic materials and components, material compounds and the manufacturing of semi-finished products for the application in medical technology.