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ISO/IEC 17025 directory

IEC 60601-2-18 Accredited Testing Labs in United States

10 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-18 testing. From the accredited scope text: “IEC 60601-2-18 Edition 3.0 2009-08 9-114 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 6-461 IEC 60601-2-20 Edition 2.1 2016-04 6-462 IEC 60601-2-21 Edition 2.1 2016-04 6-463 IEC 60601-2-22 Edition” “IEC 60601-2-18: Edition 3.0 2009-08 (clause 202 only) 9-114 IEC 60601-2-19 Edition 3.0 2020-09 (clause 202 only) 6-461 IEC 60601-2-20 Edition 3.0 2020-09 (clause 202 only) 6-462 IEC 60601-2-21 Edition” “IEC 60601-2-18; IEC 60601-2-18 Edition 3.0 2009-08; IEC 60601-2-22; IEC 60601-2-22 Edition 3.1 2012-10; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-25; IEC 60601-2-25 Edition 2.0 2011-10; IEC 6060” “IEC 60601-2-18 Edition 3.0 2009-08 Photobiological safety of lamps and lamp systems IEC 62471 Edition 1.0 b:2006 Exclusion: Wavelength range 1100nm - 3000nm Ophthalmic Instruments Ophthalmic instrumen”

Labs
10
Primary AB
A2LA10 labs

Accredited Labs

Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 60601-2-18: Edition 3.0 2009-08 9-114 IEC 60601-2-19 Edition 3.0 2020-09 6-461 IEC 60601-2-21 Edition 3.0 2020-09 6-463 IEC 60601-2-22 Edition 3.1 2012-10 12-268 IEC 60601-2-22 Edition 4.0 2019-11 12-356 IEC 60601-2-23 Edition 3.0

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Device Conformity and Testing

Devens, MA, US

Scope

IEC 60601-2-18:2009-08

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UL LLC

Novi, MI, US

Scope

IEC 60601-2-18: Edition 3.0 2009-08 (clause 202 only) 9-114 IEC 60601-2-19 Edition 3.0 2020-09 (clause 202 only) 6-461 IEC 60601-2-20 Edition 3.0 2020-09 (clause 202 only) 6-462 IEC 60601-2-21 Edition 3.0 2020-09 (clause 202 only) 6-463

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Element Materials Technology Fremont Newark

Fremont, CA, US

Scope

Test: Test Method(s) 1: Generic and Product Family Standards (cont.) IEC 62236-4; EN 50155; EN 55013; KN 13; EN 55020 (only for audio/video equipment without tuner); KN 20 (only for audio/video equipment without tuner); EN 50

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-2-18; IEC 60601-2-18 Edition 3.0 2009-08; IEC 60601-2-22; IEC 60601-2-22 Edition 3.1 2012-10; IEC 60601-2-22 Edition 4.0 2019-11; IEC 60601-2-25; IEC 60601-2-25 Edition 2.0 2011-10; IEC 60601-2-27; IEC 60601-2-27 Edition 3.0

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F2 Labs

Middlefield, OH, US

Scope

IEC 60601-2-18: Edition 3.0 2009-08 (Section(s) 201.17/202) 1; ANSI AAMI IEC 60601-2-19 Edition 2.1 2016-04; ANSI AAMI IEC 60601-2-19 Edition 3.0 2020-09; ANSI AAMI IEC 60601-2-2:2017 (Section(s) 201.17/202) 1

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-18 Edition 3.0 2009-08 9-114 ANSI AAMI IEC 60601-2-19:2009/(R)2014 & A1:2016 6-461 IEC 60601-2-20 Edition 2.1 2016-04 6-462 IEC 60601-2-21 Edition 2.1 2016-04 6-463 IEC 60601-2-22 Edition 3.1 2012-10 12-268 IEC 60601-2-22

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-2-18;

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-2-18 Edition 3.0 2009-08 Photobiological safety of lamps and lamp systems IEC 62471 Edition 1.0 b:2006 Exclusion: Wavelength range 1100nm - 3000nm Ophthalmic Instruments Ophthalmic instruments – Fundamental Requiremen

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-2-18 Edition 3.0 2009-08 9-114 IEC 60601-2-19 Edition 3.0 2020-09 6-461 IEC 60601-2-20 Edition 3.0 2020-09 6-462 IEC 60601-2-21 Edition 3.0 2020-09 6-463 IEC 60601-2-22 Edition 3.1 2012-10 12-268 IEC 60601-2-22 Edition 4.0 20

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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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