15 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 10993-18 testing. These labs commonly handle Metal, Medical devices matrices. From the accredited scope text: “ISO 10993-18 : 2021-03 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) DIN EN ISO 10993-2” “ISO 10993-18 : 2023-11 Biologische Beurteil ung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen für Medizinprodukte im Rahmen eines Risikomanagementsystems (ISO 10993-18:20” “ISO 10993-18 : 2021-03 Biologische Beurteilu ng von Medizinprodukten - Teil 18, Chemische Charakterisierung von Werkstoffen (ISO 10993- 18:2020); Deutsche Fassung EN ISO 10993-18:2020 DIN EN ISO 10993” “ISO 10993-18: 2021-03 DIN ENISO 18562-1: 2020-05 DIN EN ISO 18562-4: 2020-05 TSOP-0002-SW-M ED-V03 TSOP-0003-SW-M ED-V03 TSOP-0004-SW-M ED-V03 TSOP-0005-SW-MED-V03 TSOP-0006-SW-MED-V03 TSOP-0007-SW-ME”
This page is a fixed slice of the register: every ISO 10993-18 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.