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ISO/IEC 17025 directory

IEC 60601-2-37 Accredited Testing Labs in United States

10 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-37 testing. From the accredited scope text: “IEC 60601-2-37 Edition 2.1 2015 (clauses 201.17, 202 only) 12-293 IEC 60601-2-44 Edition 3.2: 2016 (clause 202 only) 12-302 IEC 60601-2-45 Edition 3.1 2015 (clause 202 only) 12-294 IEC 60601-2-47 Edit” “IEC 60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment); EN/IEC 60601-2-38 (Electrically Operated Hospital Beds); EN/IEC 60601-2-39 (Peritoneal Dialysis Equipment); EN/IEC 60601-2-40 (” “IEC 60601-2-37 Edition 2.1 2015 (Section(s) 201.17/202) 1; IEC 60601-2-37 Edition 3.0 2024-07; IEC 60601-2-43 - Ed. 2.0 2010-03 (Section(s) 201.17/202) 1; IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDAT” “IEC 60601-2-37 (Ed. 2 + Am 1, Ed. 3) (excluding cl 201.12); IEC 60601-2-38; IEC 60601-2-40 (Ed. 1, Ed. 2, Ed. 3); IEC 60601-2-41 (Ed. 2 + Am 1, Ed. 3); IEC 60601-2-46 (Ed. 3, Ed. 4); IEC 60601-2-49 (E”

Labs
10
Primary AB
A2LA10 labs

Accredited Labs

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

Test Technology: Test Method(s) 1, 2: Generic / Product Family / Product Specific Standards (cont.) EN 60601-2-37 (2008) + A1 (2015), clause 202; IEC 60601-2-47 Ed. 2.0 (2012-02), clause 202; IEC 60601-2-49 (2011), clause 202; E

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-2-37 (Ed. 2 + Am 1, Ed. 3) (excluding cl 201.12); IEC 60601-2-38; IEC 60601-2-40 (Ed. 1, Ed. 2, Ed. 3); IEC 60601-2-41 (Ed. 2 + Am 1, Ed. 3); IEC 60601-2-46 (Ed. 3, Ed. 4); IEC 60601-2-49 (Ed. 1, Ed.2); IEC 60601-2-50 (Ed. 2

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UL LLC

Novi, MI, US

Scope

IEC 60601-2-37 Edition 2.1 2015 (clauses 201.17, 202 only) 12-293 IEC 60601-2-44 Edition 3.2: 2016 (clause 202 only) 12-302 IEC 60601-2-45 Edition 3.1 2015 (clause 202 only) 12-294 IEC 60601-2-47 Edition 2.0 2012-02 (clause 202 only) 3-1

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-2-37; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-37 Edition 3.0 2024-07 (The above standards exclude Clause 201.12.4 Acoustic Output); IEC 60601-2-38; IEC 60601-2-39; IEC 60601-2-39 Edition 3.0 2018-04; IEC 606

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F2 Labs

Middlefield, OH, US

Scope

IEC 60601-2-37 Edition 2.1 2015 (Section(s) 201.17/202) 1; IEC 60601-2-37 Edition 3.0 2024-07; IEC 60601-2-43 - Ed. 2.0 2010-03 (Section(s) 201.17/202) 1; IEC 60601-2-43 Edition 2.1 2017-05 CONSOLIDATED VERSION (Section(s) 201.17/202)

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-37 (Ultrasonic Medical Diagnostic and Monitoring Equipment); EN/IEC 60601-2-38 (Electrically Operated Hospital Beds); EN/IEC 60601-2-39 (Peritoneal Dialysis Equipment); EN/IEC 60601-2-40 (Electromyographs and Evoked Response

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UL Verification Services

Fremont, CA, US

Scope

(A2LA Certificate No. 0751.05) Revised 03/02/2026 Page 3 of 10 Test Technology: Test Method(s) 1, 2: EMC Medical (continued) IEC/EN 60601-2-25 (cl. 202 only); IEC/EN 60601-2-27 (cl. 202 only); IEC/EN 60601-2-31 (cl. 202 only); IEC/EN

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-2-37 12-293 IEC 60601-2-47 3-155 ANSI AAMI IEC 60601-2-47 3-155 IEC 61010-1 19-34 ANSI/UL 61010-1 19-41 IEC 80601-2-30 3-123 ANSI AAMI IEC 80601-2-30 3-123 ISO 80601-2-55 1-140 ISO 80601-2-56 6-421 ISO 80601-2-61 1-139 I

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-2-37 Edition 2.1 2015 12-293 IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-62 Edition 1.0 2013-07 12-281

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Bay Area Compliance

Sunnyvale, CA, US

Scope

IEC 60601-2-37 (2015); IEC TR 60601-4-2 (2016); CAN/CSA C22.2 No. 60601-1 (2008); ANSI AAMI ES60601-1 (2005/(R)2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) [Incl. AMD2:2021]; EN 60601-1-2 (2001+A1:2006,

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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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