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ISO/IEC 17025 directory

IEC 60601-1 Accredited Testing Labs in United States

13 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-1 testing. From the accredited scope text: “IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (excluding Cl. 9.5.2 Cathode ray tube test; Cl. 10.4 LED test per IEC 62471 Cl.11.4, flammable anesthetic mixtures test; Cl. 15.4.3.4 Lithium batte” “IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 19-49 IEC TR 60601-4-2 Edition 1.0 2016-05 19-19 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION” “IEC 60601-1; EN 60601-1; CAN/CSA-C22.2 No. 60601-1; IEC 60601-1:2005 + A1 (2012); IEC 60601-1:2005+AMD1:2012+AMD2:2020; ANSI/AAMI ES60601-1; ANSI/AAMI ES60601-1:2005/A2:2021; ANSI/AAMI ES60601-1:2005/” “IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 19-49 ANSI/AAMI HA60601-1-11:2015 19-16 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATE”

Labs
13
Primary AB
A2LA13 labs

Accredited Labs

Element Materials Technology Irvine

Irvine, CA, US

Scope

IEC 60601-1; EN 60601-1; CAN/CSA-C22.2 No. 60601-1; IEC 60601-1:2005 + A1 (2012); IEC 60601-1:2005+AMD1:2012+AMD2:2020; ANSI/AAMI ES60601-1; ANSI/AAMI ES60601-1:2005/A2:2021; ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)201

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (excluding Cl. 9.5.2 Cathode ray tube test; Cl. 10.4 LED test per IEC 62471 Cl.11.4, flammable anesthetic mixtures test; Cl. 15.4.3.4 Lithium battery test per IEC 62133-2 or IEC 60086-4

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Device Conformity and Testing

Devens, MA, US

Scope

IEC 60601-1:1988/AMD2:1995; IEC 60601-1:2005+A1:2012; IEC 60601-1:2005+A1:2012+A2:2020; ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text); IEC 60601-1-4:1996/AMD1:1999; IEC 60601-1-6:2010+A1

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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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Quanta Laboratories

Santa Clara, CA, US

Scope

IEC 60601-11, Sect. 10.1 3.a, b, d; ST/SG/AC.10/11, Sect. UN 38.3 T4 Packaged Drop Test/ Unpackaged Drop Test Requirements of Standard Telcordia GR-63-CORE; GR-487-CORE; GR-950-CORE; GR-3108-CORE; ETSI EN 300 019; MIL-PRF 288

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-1; EN 60601-1; IEC 60601-1 Edition 3.2 2020-08 Consolidated Version (The above standards exclude 60601-1: Clause 9.5.2 Cathode Ray Tubes, Clause 11.4 MEE and MES intended for use with flammable anaesthetics, Cla

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 19-49 IEC TR 60601-4-2 Edition 1.0 2016-05 19-19 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 [

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Applied Technical Services

Tempe, AZ, US

Scope

IEC 60601-1 Drop IEC 60601-1 Impact IEC 60601-1 Temperature Altitude2 Up to 100,000 Feet (-72 to 150) °C MIL-STD-202 E, F, G, (Method 105); MIL-STD-810 Base, A, B, C, D, E, F, G, H, (Method 500); RTCA/DO-160 B, C, D, E, F, G, (Sec

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UTEST Technical Laboratory Co. Ltd.

Guangzhou, US

Scope

IEC 60601-1; EN 60601-1 Power Transformers, Power Supplies, Reactors and Similar Products IEC 61558-1; IEC 61558-2-5; IEC 61558-2-6; IEC 61558-2-9; IEC 61558-2-15; IEC 61558-2-16; EN 61558-1; EN 61558-2-5; EN 61558-2-6; EN 61558-2-

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-1, Edition 3.2 Series Test Technology: Test Method(s) 2, 3, 4: National / Regional Variation(s) 2, 3, 4: Medical Electrical Equipment– Part 1: General Requirements for Basic Safety and Essential performance (excludin

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-1 Edition 3.2 2020-08 Clauses 4-9, 11- 16; ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 3 Medical Electrical Equipment- Part 2-5: Particular Requirements for the Basic Safety and Essent

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Bay Area Compliance

Sunnyvale, CA, US

Scope

IEC 60601-1 (2012); UL 60601-1 (2006); EN 60601-1 (2006+A1:2013); IES 60601-2-22 (2007+A1:2012); EN 60601-2-22 (2013); IEC 60601-1-9 (2007) IEC 60601-1-12 (2014); IEC 60601-2-37 (2015); IEC TR 60601-4-2 (2016); CAN/CSA C22.2 No. 60601-1

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION 19-49 ANSI/AAMI HA60601-1-11:2015 19-16 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601

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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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