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ISO/IEC 17025 directory

ISO 80601-2-84 Accredited Testing Labs in United States

3 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 80601-2-84 testing. From the accredited scope text: “ISO 80601-2-84 Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment ISO 80601-” “ISO 80601-2-84 (Ed. 1, Ed. 2); ISO 81060-1 (Ed. 1); UL 60601-1 (Ed. 1) Emissions Radiated and Conducted 47 CFR, FCC Part 11; 47 CFR, FCC Part 15B (using ANSI C63.4:2014); ICES-001; ICES-003; IEC/CISPR”

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About ISO/IEC 17025 in United States

American Association for Laboratory Accreditation (A2LA) is the primary accreditation body issuing ISO/IEC 17025 accreditation for testing laboratories in United States.

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.

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