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ISO/IEC 17025 directory

IEC 80601-2-35 Accredited Testing Labs in United States

3 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 80601-2-35 testing. From the accredited scope text: “IEC 80601-2-35 (Ed. 1 + Am 1) (excluding cl 201.8.8.4.101); IEC 80601-2-49 (Ed. 1); IEC 80601-2-60 (Ed. 1, Ed. 2); ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2); ISO 80601-2-69 (Ed. 2); IEC 62” “IEC 80601-2-35; IEC 60601-2-83; IEC 60601-2-83:2019; IEC 60601-2-83:2019+AMD1:2022 Laboratory Equipment (excluding Vicat Softening and CRT/High Vacuum) IEC 61010-1 (Ed 3, Ed 3.1)3; IEC 61010-1 Edition” “IEC 80601-2-35:2009; ANSI/AAMI/IEC 80601-2- 35:2009; EN ISO 80601-2-35:09 + A11:2011 + AC:2015; CAN/CSA C22.2 No. 80601-2- 35:2012; Ultrasonic Monitoring and Diagnostic Equipment IEC 60601-2-37:2007;”

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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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