8 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-31 testing. From the accredited scope text: “IEC 60601-2-31 : 2021-07 DIN EN 60601-2-33 : 2017-11 DAkkS Deutsche Akkreditierungsstelle Medizinische elektrische Geräte - Teil 2-27: Besondere Festlegungen für die Sicherheit einschließlich der wese” “IEC 60601-2-31 : 2021-07 Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Herzschrittmachern m” “IEC 60601-2-31 : 2008-03 ⊗ Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source + Amen” “IEC 60601-2-31 : 2020 IEC 60601-2-33 : 2010-03 K DAkkS Deutsche Akkreditierungsstelle Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance o”
This page is a fixed slice of the register: every IEC 60601-2-31 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.