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ISO/IEC 17025 directory

IEC 60601-2-63 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-63 testing. From the accredited scope text: “IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION (clause 202 only) 12-339 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION (clause 202 only) 12-340 IEC 80601-2-77 Edition 1.0 2019-07 (cl” “IEC 60601-2-63:2012 IEC 60601-2-63:2012/AMD1:2017 IEC 60601-2-63:2012/AMD2:2021 CSA C22.2 No. 60601-2-63-15 (R2020) Medical electrical equipment - Part 2-64: Particular requirements for the basic safe” “IEC 60601-2-63 (Dental Extra-oral X-ray Equipment); IEC 60601-2-65 Dental Intra-Oral X-Ray Equipment; EN/IEC 60601-2-68 (X-ray-based Image-guided Radiotherapy Equipment for use with Electron Accelerat” “IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION 12-339 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION 12-340 ISO 80601-2-12 Second edition 2020-02 1-146 IEC 80601-2-30 Edition 2.0 201”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION 12-339 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION 12-340 ISO 80601-2-12 Second edition 2020-02 1-146 IEC 80601-2-30 Edition 2.0 2018-03 3-123 ANSI AAMI IEC 80601-2-30:

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UL LLC

Novi, MI, US

Scope

IEC 60601-2-63 Edition 1.2 2021-05 CONSOLIDATED VERSION (clause 202 only) 12-339 IEC 60601-2-65 Edition 1.2 2021-05 CONSOLIDATED VERSION (clause 202 only) 12-340 IEC 80601-2-77 Edition 1.0 2019-07 (clauses 201.17, 202 only) 6-438 I

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EUROFINS ELECTRICAL AND ELECTRONIC TESTING NA

Suite A Irvine, CA, US

Scope

IEC 60601-2-63:2012 IEC 60601-2-63:2012/AMD1:2017 IEC 60601-2-63:2012/AMD2:2021 CSA C22.2 No. 60601-2-63-15 (R2020) Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of li

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-2-63 (Ed. 1 + Am1 + Am2); IEC 60601-2-63 Edition 1.2 2021-05; IEC 60601-2-64 (Ed. 1); IEC 60601-2-64 Edition 1.0 2014-09; IEC 60601-2-66 (Ed. 1; Ed. 2; Ed. 3); IEC 60601-2-68 (Ed. 1; Ed. 2); IEC 60601-2-68 Edition 1.0 201

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-63 (Dental Extra-oral X-ray Equipment); IEC 60601-2-65 Dental Intra-Oral X-Ray Equipment; EN/IEC 60601-2-68 (X-ray-based Image-guided Radiotherapy Equipment for use with Electron Accelerators, Light Ion Beam Therapy Equipment

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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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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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