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Registers collected 2026-08-22.See collection dates
ISO/IEC 17025 directory

IEC 60601-2-49 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-49 testing. From the accredited scope text: “IEC 60601-2-49 (Multifunction Patient Monitoring Equipment); EN/IEC 60601-2-50 (Infant Phototherapy Equipment); EN/IEC 60601-2-51 (Recording and Analyzing Single Channel and Multichannel Electrocardio” “IEC 60601-2-49 (Ed. 1, Ed.2); IEC 60601-2-50 (Ed. 2 + Am1, Ed. 3 + Am1); IEC 60601-2-51; IEC 60601-2-52 (Ed. 1 + Am 1); IEC 80601-2-26 (Ed. 1 + Am 1); IEC 80601-2-30 (Ed. 1.1, Ed. 2.0); ANSI/AAMI/IEC” “IEC 60601-2-49; IEC 60601-2-52; IEC 60601-2-52 Edition 1.0 2009-12; IEC 60601-2-52 Edition 1.1 2015-03 Consolidated Version; IEC 60601-2-66; IEC 60601-2-68;” “IEC 60601-2-49 (2011), clause 202; EN 60601-2-49 (2015), clause 202; 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 8”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

IEC 60601-2-49 (2011), clause 202; EN 60601-2-49 (2015), clause 202; 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

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-2-49 (Ed. 1, Ed.2); IEC 60601-2-50 (Ed. 2 + Am1, Ed. 3 + Am1); IEC 60601-2-51; IEC 60601-2-52 (Ed. 1 + Am 1); IEC 80601-2-26 (Ed. 1 + Am 1); IEC 80601-2-30 (Ed. 1.1, Ed. 2.0); ANSI/AAMI/IEC 80601-2-30:2018; IEC 80601-2-35

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-2-49; IEC 60601-2-52; IEC 60601-2-52 Edition 1.0 2009-12; IEC 60601-2-52 Edition 1.1 2015-03 Consolidated Version; IEC 60601-2-66; IEC 60601-2-68;

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-49 (Multifunction Patient Monitoring Equipment); EN/IEC 60601-2-50 (Infant Phototherapy Equipment); EN/IEC 60601-2-51 (Recording and Analyzing Single Channel and Multichannel Electrocardiographs); EN/IEC 60601-2-52 (Medical

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

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 Temperature Measurement IS

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-2-49 (1Ed 2001; 2Ed 2011); EN 60601-2-49 (2001, 2015); CAN/CSA-C22.2 No. 60601-2-49 (2004+R:2009; 2011); IEC 60601-2-51 (1Ed 2003); EN 60601-2-51 (2003); CAN/CSA-C22.2 No. 60601-2-51 (2004+R:2009); IEC 60601-2-52

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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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