6 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-65 testing. From the accredited scope text: “IEC 60601-2-65 : 2012-09 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment + Amendment 1 : 2017 + Am” “IEC 60601-2-65:2012 + A1:2017 + A2:2021); Deutsche Fassung EN 60601-2-65:2013 + A1:2020 + A2:2021 VDE 0750-2-65:2022-07 DIN EN 60601 -2-65 : 2016 -11 ⊗ - Medizinische elektrische Geräte - Teil 2-65: B” “IEC 60601-2-65:2012 + A1:2017 + A2:2021); German version EN 60601-2-65:2013 + A1:2020 + A2:202 Abbreviations used: DIN Deutsches Institut für Normung e.V. – German in stitute for standardization EN Eu” “IEC 60601-2-65 − radiographic- and radioscopic equipment DIN EN 60601-2-54 IEC 60601-2-54 − X-ray equipment for interventional procedures DIN EN IEC 60601-2-43 Equipment for monitoring Compliance test”
This page is a fixed slice of the register: every IEC 60601-2-65 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.