30 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 10993-12 testing. These labs commonly handle Pharmaceuticals, Metal, Water matrices. Most frequently tested analytes via this method in Germany: Zytotoxizität, Ethylenoxid, Hämolyse. From the accredited scope text: “ISO 10993-12 : 2021-08 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) DIN EN ISO 10993-18 : 2021-03 Biological evaluation of medical” “ISO 10993-12:2021) DIN EN ISO 10993 -18: 2021 -03 Biologische Beurteilung von Medizinprodukten – Teil 18: Chemische Charakterisierung von Werkstoffen (ISO 10993-18:2020) DIN EN ISO 10993 -23: 2021 -10” “ISO 10993-12 : 2021-08 Biologische Beurteilu ng von Medizinprodukten - Teil 12: Probenvorbereitung und Referenzmaterialien DIN EN ISO 11737-1 : 2021-10 Sterilisation von Prod ukten für die Gesundheits” “ISO 10993-12:2021) DIN EN ISO 10993-23: 2021-10 Biologische Beurteilung von Medizinprodukten - Teil 23: Prüfungen auf Irritation (ISO 10993-23:2021) DIN EN ISO 20743: 2021-10 Textilien - Bestimmung de”
This page is a fixed slice of the register: every ISO 10993-12 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.