8 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 10993-4 testing. Most frequently tested analytes via this method in Germany: Hämolyse. From the accredited scope text: “ISO 10993-4 : 2017-12 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) DIN EN ISO 10993-5 : 2009-10 Biological evaluation of medical” “ISO 10993-4:2017) DIN EN ISO 10993 -5: 2009 -10 Biologische Beurteilung von Medizinprodukten; Teil 5: Prüfungen auf In-vitro-Zytotoxizität (ISO 10993-5:2009) DIN EN ISO 10993 -6: 2017 -09 Biologische” “ISO 10993-4 : 2017-12 Biologische Beurteilun g von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO 10993-4:2017) DIN EN ISO 10993-5 : 2009-10 Biologische Beurteilung” “ISO 10993-4 ASTM F756-00 Mitgeltend: DIN EN ISO 10993-1 DIN EN ISO 10993-12 Prüfung auf Zytotoxizität - Direktkontakt-Test - Test an Extrakten - Agardiffusions-Test - Stoffwechsel- aktivität nach Kont”
This page is a fixed slice of the register: every ISO 10993-4 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.