Phone: +49 3672 379 - 0

Ostthüringische Materialprüfgesellschaft für Textil und Kunststoffe mbH

Biocompatibility

REM-picture

REM-picture

At our modern cell culture laboratory we determine the in vitro cytotoxicity of medical products, cosmetics and other products in accordance with DIN EN ISO 10993-5. This test is an important and essential method for assessing the biocompatibility in the scope of a conformity evaluation of medical products and for the routine check of the ongoing production or the raw materials used.

Further biocompatibility tests comprise the in vitro irritation (OECD 439) and corrosion (OECD 431) tests using 3D skin models. These tests can replace partially the animal testing for determining toxic and irritating effects. 

The microscopic assessment of toxic influences can be performed with the live-dead staining with subsequent fluorescence microscopy.

The adhesion of cells on functionalised surfaces can be determined with the cell adhesion test.

  • DIN EN ISO 10993-5 / Biologische Beurteilung von Medizinprodukten - Teil 5: Prüfungen auf In-vitro-Zytotoxizität
  • OECD 439 / In-vitro-Hautirritation
  • OECD 431 / In-vitro-Korrosion
  • eigene Methode / Zelladhäsion an eukaryotischen Zellen
  • Diaz et al. 2003 / Lebend-Tod-Fluoreszenzfärbung
  • Re et al. 1999 / TEAC-Test auf antioxidative Wirksamkeit

Biology Laboratory

Dr. Janine Bauer
Telefon: + 49 3672 379 - 521
Fax: + 49 3672 379 - 379
Email: j.bauer@titk.de

Accreditation

OMPG is an accredited testing laboratory according to DIN EN ISO / IEC 17025.

Accreditation certificate (PDF)
Annex to accreditation certificate (PDF)

Contact

Ostthüringische Materialprüfgesellschaft für Textil- und Kunststoffe mbH

Breitscheidstraße 97
07407 Rudolstadt
Germany

Phone: + 49 3672 379 - 0
Fax: + 49 3672 379 - 379
Email: info@titk.de