According to the Medical Devices Act, materials must undergo numerous safety tests before coming in contact with patients and users. One of these required tests is to demonstrate the biocompatibility, regardless whether the medical device is used for short term, long term or even permanent contact.
Since 2006 the Fraunhofer IGB has established an accredited test method for the evaluation of medical devices. In vitro-cytotoxicity testing is performed according to DIN ISO 10993-5. A human keratinocyte cell line is used to guarantee a better transferability of the results (human not murine).
With our many years of experience at Fraunhofer IGB we perform biocompatibility/cytotoxicity tests according to DIN ISO 10993-5 standard as a service for our industry partners.
The evaluation of in vitro-cytotoxicity on cell culture is determined by material extraction done according to DIN EN ISO 10993-12. Depending on the material and its characteristics a suitable extraction ratio is selected. The extraction is carried out under standardized conditions and extraction time is adapted to the material application. In the following test, the obtained original extracts and / or dilutions are tested on a sub-confluent cell layer with respect to their cytotoxic potential.
The proliferation of the cell culture is determined using a colorimetric test. Based on negative controls, positive controls and blinded controls, the proliferation of the cells is calculated and the cytotoxic potential of the material is determined with a cytotoxicity scale. The classification of the cytotoxic potential of the material and the proper conduct of the investigation is confirmed with the signature of the study director and summarized for the customer in a detailed report
Accreditation – Our In vitro cytotoxicity test method according to DIN ISO 10993-5 is certified since 2006. In June 2014 our accredited test area has been assessed by Deutsche Akkreditierungsstelle GmbH (DAkkS) and confirmed with a certificate in December 2014 as an accredited testing laboratory with all the testing procedures.