IEC 80601 Accredited Testing Labs in United States
IEC 80601, all parts: Medical electrical equipment11 laboratories in United States are accredited by A2LA for at least one part of IEC 80601. Each lab card shows which parts it holds. From the accredited scope text: “IEC 80601-2-77 Edition 1.0 2019-07 (clauses 201.17, 202 only) 6-438 IEC/TR 60601-4-2 Edition 1.0 2016-05 19-19 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50” “IEC 80601-2-26 Medical Electrical Equipment - Part 2-26: Particular Requirements For The Basic Safety And Essential Performance Of Electroencephalograph IEC/EN 60601-2-27 Medical electrical equipment” “IEC 80601-2-30 (Automated Non-Invasive BP)” “IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30 (excluding 201.15.3.5); IEC 80601-2-60; EN 80601-2-60; CAN/CSA-C22.2 No. 80601-2-60, (excluding 201.10.4); ISO 80601-2-61; EN 80601-2-61; CAN/CS”
This page is a fixed slice of the register: every IEC 80601 scope we hold for United States. 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.