5 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-16 testing. From the accredited scope text: “IEC 60601-2-16 : 2020-05 Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations-” “IEC 60601-2-16 VDE 0750-2-16:2020-05 Medical electrical equipment - Part 2 -16: ParDcular requirements for basic safety and essenDal performance of haemodialysis, haemodiafiltraDon and haemofiltraDon eq” “IEC 60601-2-16; IEC 60601-2-16 Edition 5.0 2018-4; IEC 60601-2-16:2025; ANSI AAMI IEC 60601-2-16; ANSI AAMI IEC 60601-2-16:2018; CSA C22.2 No. 60601-2-16; EN IEC 60601-2-16 IEC 60601-2-10; IEC 60601-2” “IEC 60601-2-16 DIN EN 60601-2-24 IEC 60601-2-24 DIN EN IEC 60601-2-39 - Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten - Infusionspumpen und - steuergeräte - Peritoneal-Dialyse-Geräte Be”
This page is a fixed slice of the register: every IEC 60601-2-16 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.