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ISO/IEC 17025 directory

IEC 60601-1-2 Accredited Testing Labs in United States

43 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-1-2 testing. From the accredited scope text: “IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50” “IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 5-132 IEC 60601-1-8 Editio” “IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC 60601-2-2 Edition 6.0 2017-03 (clauses 201.17, 202.7, 202.8 only) 6-389 IEC 60601-2-5: Edition 3.0 2009-07 (clause 201.17 only) 12-205” “IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 1These methods have been assessed by A2LA according to A2LA’s FDA ASCA Program requirements. Accreditation by A2LA does not imply FDA ASCA-”

Labs
43
Primary AB
A2LA43 labs

Accredited Labs

Element Materials Technology Denver-Longmont

Longmont, CO, US

Scope

IEC 60601-1-2; EN 60601-1-2; KS C IEC 60601-1-2; EN 61326-1; CISPR 24; EN 55024; KS C 9824 CISPR 35 (excluding Annex A-H); EN 55035 (excluding Annex A-H); KS C 9835 (excluding Annex A-H); CISPR 14-2; EN 55014-2; KS C 9814-2; ISO 7176

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BEC Incorporated

Pottstown, PA, US

Scope

Test Technology: Test Methods 1, 2: Conducted Immunity EN 61000-4-6; IEC 61000-4-6 Magnetic Field Immunity EN 61000-4-8; IEC 61000-4-8 Voltage Dips, Short Interruptions, and Voltage Variations EN 61000-4-11; IEC 61000-4-11 Pr

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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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Core Compliance Testing Services

Hudson, NH, US

Scope

IEC 60601-1-2; KS C IEC 60601-1-2; EN 60945; IEC 60945; KS X 3140; EN 61000-6-1; IEC 61000-6-1; AS/NZS 61000-6-1; KS C 61000-6-1; KS C 9610-6-1; EN 61000-6-2; IEC 61000-6-2; AS/NZS 61000-6-2; KS C 9610-6-2; EN 61326; IEC 61326;

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Nebraska Center for Excellence in Electronics

Lincoln, NE, US

Scope

IEC 60601-1-2; EN 60601-1-2 Electrical Equipment for Measurement, Control, and Laboratory Use IEC 61326-1; EN 61326-1 Requirement for EMC Unprotected Area IEC 61326-2-1; EN 61326-2-1 Requirements for Transducers with Integrated

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Compliance Worldwide

Sandown, NH, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 1These methods have been assessed by A2LA according to A2LA’s FDA ASCA Program requirements. Accreditation by A2LA does not imply FDA ASCA-Accreditation. All ASCA-accredit

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Element Materials Technology Irvine

Irvine, CA, US

Scope

(A2LA Certificate No. 3310.04) Revised 07/28/2025 Page 6 of 13 Test Technology: Test Method(s) 2: MED (excluding Risk Assessment, Defibrillation Protection, Ca

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TUV SUD America

Alpharetta, GA, US

Scope

IEC 60601-1-2; KS C 9814-1; KS C 9814-2; KS C 9815; KS C 9547; KS X 3124; KS X 3125; KS X 3126; KS X 3127; KS X 3130; KS X 3139; KS X 3135; KS X 3129; KS X 3140; KS C 9040-2; KS C 9832; KS C 9835; KS X 3140; KS C 9610-

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EMTEK (Shenzhen) Co.,

Shenzhen, US

Scope

IEC 60601-1-2; ANSI/AAMI/IEC 60601-1-2

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TUV SUD America - Auburn Hills

Auburn Hills, MI, US

Scope

Test Technology / Equipment Capabilities: Test Method(s): Battery – P&C, Constant Power Discharge INL/EXT-07 12536, Section 3.3 (Battery Test Manual for Plug-In Hybrid Electric Vehicles) Battery – Durability, Calendar INL/E

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50

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Device Conformity and Testing

Devens, MA, US

Scope

Test Technology: Test Method(s) 2: Medical Equipment1 (Cont’d) IEC 60601-2-64:2014-09; IEC 60601-2-68 Edition 1.0 2014-09 Electrical Equipment for Measurement, Control, and Laboratory Use IEC 61010-1:2010+A1:2016; IEC 61010-1 Ed

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Green Mountain Electromagnetics

Middlebury, VT, US

Scope

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 GREEN MOUNTAIN ELECTROMAGNETICS, INC. 219 Blake Roy Road Middlebury, VT 05753 Kyle R. Kowalczyk Phone: 802 388 3390 email: gme@gmelectro.com Website: www.gmelectro.com

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UL LLC

Novi, MI, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 IEC 60601-2-2 Edition 6.0 2017-03 (clauses 201.17, 202.7, 202.8 only) 6-389 IEC 60601-2-5: Edition 3.0 2009-07 (clause 201.17 only) 12-205 IEC 60601-2-6 Edition 2.1 2016-04 (c

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WESTPAK

San Jose, CA, US

Scope

Test Test Method(s) Drop Testing Drop Testing ASTM D5276 Concentrated Impact Testing ASTM D6344 Mechanical Handling of Unitized Loads ASTM D6179 Bridge Impact Testing ASTM D5265 Incline Impact Testing ASTM D880 Horizontal Impac

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ATLAS Compliance & Engineering

San Jose, CA, US

Scope

IEC 60601-1-2; EN 61000-6-3 2; KS C 9610-6-3; EN 61000-6-42; KS C 9610-6-4; GB 9254:2008; GB 9254; CNS 15936:2016 Harmonics IEC 61000-3-2:2014 2; IEC 61000-3-2:2018 2; IEC 61000-3-2 2; EN 61000-3-2:2014 2; EN 61000-3-2:2019 2; EN

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Element Materials Technology Fremont Newark

Fremont, CA, US

Scope

IEC 60601-1-2; EN 60601-1-2; KS C IEC 60601-1-2; IEC TS 60601-4-2; EN 60601-2-2 (Section 202 only); EN 60601-2-10 (Section 202 only); EN 60601-2-18 (Section 202 only); EN 60601-2-22 (Section 201.17 only); EN 60601-2-24 (Section 20

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EUROFINS ELECTRICAL AND ELECTRONIC TESTING NA

Suite A Irvine, CA, US

Scope

Test Technology: Test Method(s) 1, 2: Intentional Radiators (Using ANSI C63.4:2014, ANSI C63.26:2015; ANSI C63.27, and ANSI C63.10:2013 up to 40 GHz; excluding HAC and SAR unless otherwise noted) (cont.) KS X 3124; KS X 3137;

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Sporton International (USA)

Milpitas, CA, US

Scope

IEC 60601-1-2, EN 60601-1-2 UK- Emissions & Immunity BS EN 55011; BS EN 55015 (excluding 9kHz-30MHz); BS EN 55032; BS EN 55035; BS EN IEC 61000-3-2; BS EN IEC 61000-3-3; BS EN IEC 61000-4-2; BS EN IEC 61000-4-3; BS EN IEC 61000-4-4;

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Quanta Laboratories

Santa Clara, CA, US

Scope

Test Technology: Test Capabilities: Test Specifications/Standards: Humidity1 (5 to 95) %RH Telcordia GR-63-CORE; GR-487-CORE; GR-950-CORE; GR-3108-CORE; MIL-STD-810F, G, and H; MIL-STD-810H Method 507.6; MIL-STD-202; RTCA

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Packaging Compliance

Kentwood, MI, US

Scope

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 PACKAGING COMPLIANCE LABS, LLC 10 Cook Street Suite 3 Billerica MA, 01821 Ryan Ott Phone: (616) 227 - 4540 E-mail: rott@pkgcompliance.com MECHANICAL Valid To: August 31, 2

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Intertek Testing Services NA

Kentwood, MI, US

Scope

Test: Test Method(s) 1,2 : Medical (cont.) IEC 60601-1-11; IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version (The above st

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Element Materials Technology San Jose, CA

San Jose, CA, US

Scope

IEC 60601-1-2; TCVN 7317:2003; TCVN 7189:2009; TCVN 7317:2003 EMC for Radio Equipment and Services (Emissions Only, Excluding Harmonics, Flicker and Immunity) ETSI EN 301 489-1; ETSI EN 301 489-3; ETSI EN 301 489-4; ET

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F2 Labs

Middlefield, OH, US

Scope

Test Technology: Test Method(s) 1: Medical (cont.) ANSI AAMI IEC 60601-2-20 Edition 2.1 2016-04 (Section(s) 201.17/202) 1; ANSI AAMI I

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ELEMENT MATERIALS TECHNOLOGY DENVER – LONGMONT

Longmont, CO, US

Scope

Test: Parameters: Test Method(s) 1: Temperature / Humidity (5 to 95) % RH BellCore GR-63-CORE 5.1.1.3 and 5.1.2; IEC 68-2-30, Test Db; MIL-STD-810E, Method 507.3; MIL-STD810F, Method 507.4; MIL-STD-810G, Method 507.5; MIL STD-

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 5-132 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-

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BUREAU VERITAS CONSUMER PRODUCTS SERVICES

Littleton, MA, US

Scope

Test Technology: Test Method(s) 1,2: Product Family and Industry Specific Standards (includes Emissions and Immunity Tests and EN and IEC equivalents) ANSI C62.41; ANSI T1.315:2007; ANSI C63.27:2021; AS

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HCT America

Milpitas, CA, US

Scope

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; ANSI/AAMI/IEC 60601-1-2; KS C IEC 60601-1-2

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Applied Technical Services

Tempe, AZ, US

Scope

Test: Test Method(s)1: Temperature/Humidity2 (5 to 95) %RH (continued) MIL-STD-1576 (All); RTCA/DO-160 B, C, D, E, F, G, (Section 6); SAE/USCAR 24 (Inflator Requirements) June 2004; SAE/USCAR 28 (Initiator Requirements) June 2005;

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UL Verification Services

Fremont, CA, US

Scope

IEC 60601-1-2; IEC/TR 60601-4-2 Edition 1.0 2016-05; IEC TS 60601-4-2 Edition 1.0 2024-03 Automotive EMC Automotive Radiated & Conducted Emissions CISPR 25 (2016, 2021) Section 6.5; CISPR 25 (2016, 2021) Sections 6.3 and 6.4;

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UTEST Technical Laboratory Co. Ltd.

Guangzhou, US

Scope

Test Technology: Test Method(s)2 Household and Similar Equipment EN 60335-1; EN 60335-2-2; EN 60335-2-3; EN 60335-2-6; EN 60335-2-8; EN 60335-2-9; EN 60335-2-10; EN 60335-2-12; EN 60335-2-13; EN 60335-2-14; EN 60335-2-15; EN 60335-2-1

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Shenzhen UnionTrust Quality and Technology Co.,

Shenzhen,Guangdong, US

Scope

IEC 60601-1-2; EN 60601-1-2; BS EN 60601-1-2; EN 61326-1; EN 61326-2-1; EN 61326-2-2; EN 61326-2-3; EN 61326-2-4; EN 61326-2-5; EN 61326-2-6; EN IEC 61326-1; EN IEC 61326-2-1; EN IEC 61326-2-2; EN IEC 61326-2-3; EN IEC 61326-

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

Peritoneal Dialysis Equipment IEC 60601-2-39:20181; EN 60601-2-39:2019; GB 9706.239:2021; CSA C22.2 No. 60601-2- 39:2023; Electromyographs and Evoked Response Equipment IEC 60601-2-40:2016; CAN/CSA C22.2 No. 60601-2- 40:2017; E

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Radiometrics Midwest Corporation

Romeoville, IL, US

Scope

IEC 60601-1-2:2014; EN 61000-6-1:2019; EN 61000-6-2:2019; EN 61000-6-3:2021; EN 61000-6-4:2019; EN 61326-1:2020; RESNA WC-2:2009 (Section 21); ETSI EN 301 489-1 V2.2.3; ETSI EN 301 489-3 V2.1.1; ETSI EN 301 489-17 V3.2.4; ETSI EN 3

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Sigma Scientific Services

Sunrise, FL, US

Scope

Test Technology: Test Method(s): Medical Endoscopes (continued) Photography — Electronic still-picture imaging — Noise measurements ISO 15739 3rd Edition (2017-05) Photography — Electronic still picture imaging — Resolution

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Bay Area Compliance

Sunnyvale, CA, US

Scope

IEC 60601-1-2; KS C 9814-1:2020; KS C 9990; KS C 9814-2; KS X 3126; KS X 3128; KS X 3131; KS X 3127; KS X 3130; KS X 3135; KS X 3132; KS X 3136 ; KS X 3137; KS X 3134; KS X 3138; KS X 3139; KS C 9040-2; KS X 3129:2020; K

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DEKRA Certification

Sterling, VA, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED Version; ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]; ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] On the Following Types of Products: Base Stations, Subscriber Station

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Element Materials Technology St. Paul

St. Paul, MN, US

Scope

Test(s): Test Method(s): Environmental Simulation: Humidity MIL-STD-202 (Method 103B), MIL-STD-810 (Method 507) Fluorescent UV- Condensation, Light- and Water-Exposure (QUV) ASTM G154 Salt Spray (Fog) ASTM B117; MIL-STD-202

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Element Materials Technology Boxborough

Boxborough, MA, US

Scope

Tests: Test Method(s) 1: Immunity Electrostatic Discharge (ESD) IEC/EN 61000-4-2; KS C 9610-4-2; RTCA/DO-1602 D, E, F, & G (Section 25); MIL-STD-1686; MIL-STD-461G (CS118) Radiated Immunity IEC/EN 61000-4-3; KS C 9610-4-3; RT

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International Compliance

Neenah, WI, US

Scope

IEC 60601-1-2:2001; IEC 60601-1-2:2007; IEC 60601-1-2 Information Technology Equipment CISPR 24; EN 55024 (Excluding Annex A, CISPR 20) Household Appliances and Similar CISPR 14-2; EN 55014-2 (Excluding IEC 61000- 4-22) Industr

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION 5-132 IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5

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ElectroMagnetic Investigations

Hillsboro, OR, US

Scope

IEC 60601-1-2; EN 60601-1-2; KS C IEC 60601-1-2; IEC 61000-6-1; EN 61000-6-1; KS C 9610-6-1; IEC 61000-6-2; EN 61000-6-2; KS C 9610-6-2 Radio Intentional Radiators FCC CFR 47, Part 15 Subparts C, E, F, G, and H (using ANSI C63.1

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CETECOM

Milpitas, CA, US

Scope

IEC 60601-1-2; EN 60601-1-2 Harmonic Current Emissions EN 61000-3-2; IEC 61000-3-2; KS C 9610-3-2; CNS 14934-2 Voltage Fluctuations and Flicker EN 61000-3-3; IEC 61000-3-3; KS C 9610-3-2; CNS 14934-3 Generic and Pro

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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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