4 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 80601-2-58 testing. From the accredited scope text: “IEC 80601-2-58:2014 + A1:2016); Deutsche Fassung EN 80601-2-58:2015 + A1:2019 DIN EN 80601-2-58 : 2015-11⊗ - Medizinische elektrische Geräte - Teil 2-58: Besondere Festlegungen für die Sicherheit eins” “IEC 80601-2-58:2014 + A1:2016); German version EN 80601-2- 58:2015 + A1:2019 DIN EN 80601-2-58 : 2015-11 ⊗ - Medical electrical equipment - Part 2-58: Particular requirements for basic safety and esse”
This page is a fixed slice of the register: every IEC 80601-2-58 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.