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ISO/IEC 17025 directory

IEC 80601-2-49 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 80601-2-49 testing. From the accredited scope text: “IEC 80601-2-49 (Multifunction Patient Monitoring Equipment); IEC 80601-2-58 (Vitrectomy); IEC 80601-2-61; ISO 80601-2-61 3; IEC 80601-2-77 Lighting IEC 60598-1:2003; IEC / EN 60598-1; IEC 60598-1:2003” “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 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (exclu” “IEC 80601-2-49 (2018), clause 202; IEC 60601-2-50, Ed. 2.1 (2016-04); IEC 60601-2-50:2021; ISO 80601-2-55 (2018), clause 202; ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; IEC 80601-2” “IEC 80601-2-49; IEC 80601-2-49 Edition 1.1 2024-09 Consolidated Version; ISO 80601-2-56; ISO 80601-2-56 Edition 2.0 2017-03 [Including AMD1:2018]; IEC 80601-2-58; IEC 80601-2-58 Edition 2.0 2014-09; I”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

IEC 80601-2-49 (2018), clause 202; IEC 60601-2-50, Ed. 2.1 (2016-04); IEC 60601-2-50:2021; ISO 80601-2-55 (2018), clause 202; ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 806

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Intertek Testing Services NA

Duluth, GA, US

Scope

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 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (excluding Vicat Softening and CRT/

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 80601-2-49; IEC 80601-2-49 Edition 1.1 2024-09 Consolidated Version; ISO 80601-2-56; ISO 80601-2-56 Edition 2.0 2017-03 [Including AMD1:2018]; IEC 80601-2-58; IEC 80601-2-58 Edition 2.0 2014-09; IEC 80601-2-58 Edition 3.0 2024-

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 80601-2-49 (Multifunction Patient Monitoring Equipment); IEC 80601-2-58 (Vitrectomy); IEC 80601-2-61; ISO 80601-2-61 3; IEC 80601-2-77 Lighting IEC 60598-1:2003; IEC / EN 60598-1; IEC 60598-1:2003/AMD1:2006; IEC 60

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 80601-2-49:2018; EN IEC 60601-2-49:2019; Safety of Medical Beds IEC 60601-2-52:2009 + A1:20151; EN 60601-2-52:2010 + A1:2015; Respiratory Gas Monitors ISO 80601-2-55:20181; EN ISO 80601-2-55:2018; Clinical Thermometers for Body Tem

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TUV SUD America

San Diego, CA, US

Scope

IEC 80601-2-49 (3Ed 2018); ISO 80601-2-55 Second Edition 2018-02; ISO 80601-2-55 (1Ed 2011); EN ISO 80601-2-55 (2011); CAN/CSA-C22.2 No. 80601-2-55 (2014); ISO 80601-2-56 Second Edition 2017-03; ISO 80601-2-56 (1Ed 2009; 2Ed

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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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