7 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 80601-2-12 testing. From the accredited scope text: “ISO 80601-2-12 : 2020-07 DIN EN ISO 80601-2-13 : 2022-10 DIN EN IEC 80601-2-26 : 2022-04 DIN EN IEC 80601-2-30 : 2020-03 DAkkS Deutsche Akkreditierungsstelle (in conjunction with IEC 61326-1 : 2020-10” “ISO 80601-2-12 : 2020-07 Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of ventilators for intensive care use (ISO 80601-2-12:2020); G” “ISO 80601-2-12 : 2020-07 Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivp” “ISO 80601-2-12 VDE 0750-2-12:2020-07 Medical electrical equipment - Part 2 -12: ParDcular requirements for basic safety and essenDal performance of criDcal care venDlators A Product Safety IEC 60601 -”
This page is a fixed slice of the register: every ISO 80601-2-12 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.