5 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ISO 11197 testing. From the accredited scope text: “ISO 11197 : 2020-05 Medizinische Versorgungseinheiten (ISO 11197:2019); Deutsche Fassung EN ISO 11197:2019 IEC 60601-1 : 2005-12 Medical electrical equipment – Part 1: General requirements for basic s” “ISO 11197 : 2020-05 Medizinische Versorgungs einheiten (ISO 11197:2019); Deutsche Fassung EN ISO 11197:2019 DIN EN ISO 11197 : 2016-08 ⊗ - Medizinische Versorgungseinheiten (ISO 11197:2016); Deutsche” “ISO 11197:2020-05 Medical supply units (ISO 11197:2019); German version EN ISO 11197:2019 DIN EN ISO 11197:2016-08 ⊗ Medical supply units (ISO 11197:2016); German version EN ISO 11197:2016 DIN EN ISO”
This page is a fixed slice of the register: every ISO 11197 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.