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ePaper created 2017-03-14, 10:25:37 | version 1.49.03
2 Accredited test laboratories Contact The FMZ test laboratory has already been accredited under DIN EN ISO 17025:2005 as part of the Translational Center and has been recognized by the Central Authority of the Län- der for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). In this laboratory, biological tests of medical products and dental materials (DIN EN ISO 10993-5 and 10993-6, DIN EN ISO 7405) as well as inorganic-analytical test procedures are carried out. The following biological tests are currently offered: 1. Cell proliferation test after contact with extracts or after direct contact (determination of number of cells) 2. Metabolic activity after contact with extracts or after direct contact (WST-1 assay) Dr. sc. hum. Marco Metzger Group Manager Implants Phone +49 931 31-86686 marco.metzger@igb.fraunhofer.de Thorsten Bergmann Project manager QM Phone +49 931 31-82907 thorsten.bergmann@uni-wuerzburg.de 3. Protein synthesis after contact with extracts or after direct contact (Lowry protein assay) Literature 4. Cell damage and lysis after direct contact (agar diffusion [1] DIN EN ISO 9001:2015 Quality Management Systems – Re- test) quirements (ISO EN ISO 9001:2015, 2015) 5. Determination of local effects after in vivo implantation Good Laboratory Practice University Hospital of Würzburg, Chair of Tissue Engineering and Another strategically important step for covering the entire Regenerative Medicine (TERM) | University Hospital of Würz- Project partners value chain as mentioned above is the implementation of Good Laboratory Practices (GLP) within the pre-clinical study unit for animal studies. GPL is a statutory requirement for all safety-relevant questions in the context of the pre-clinical development of bioimplants. Building on the existing DIN ISO 10993-6 for the approval-relevant in vivo tests of medical products in a small animal model, GLP is to be established at the Translational Center within the next two years. burg, Chair of Functional Materials in Medicine and Dentistry (FMZ) Further information www.term.ukw.de www.fmz.uni-wuerzburg.de 1+ 2 Coordination and planning carried out by the QM Oficer (Thorsten Bergmann, Univer- sity Hospital of Würzburg) together with the Group Manager Implants (Dr. Marco Metzger, Fraunhofer IGB) to create process chains as part of the implementation of DIN EN ISO 9001 at the TZKME Würzburg. 6 3