8 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 10993-3 testing. Most frequently tested analytes via this method in Germany: Genmutationen. From the accredited scope text: “ISO 10993-3 : 2015-02 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993- 3:2014) DIN EN ISO 10993-4 : 2017-12 Biological e” “ISO 10993-3:2014) DIN EN ISO 10993 -4: 2017 -12 Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO 10993-4:2017) DIN EN ISO 10993 -5: 2009 -1” “ISO 10993-3 : 2015-02 Biologische Beurteilun g von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität, Karzinogenität und Reproduktionstoxizität (ISO 10993-3:2014) DIN EN ISO 10993-4 : 2017-12 Biol”
This page is a fixed slice of the register: every ISO 10993-3 scope we hold for Germany. Search narrows it further by city, accreditation body, or a term from the scope text itself.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.