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ISO/IEC 17025 directory

IEC 60601-2-10 Accredited Testing Labs in United States

8 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-10 testing. From the accredited scope text: “IEC 60601-2-10 Edition 2.1 2016-04 17-16 IEC 60601-2-11 Edition 3.0 2013-01 12-255 IEC 60601-2-16 Edition 5.0 2018-4 9-121 ANSI AAMI IEC 60601-2-16:2018 9-121 IEC 60601-2-17 Edition 3.0 2013-11 12-272” “IEC 60601-2-10 Edition 2.1 2016-04 (clause 202 only) 17-16 IEC 60601-2-16 Edition 5.0 2018-4 (clause 202 only) 9-121 IEC 60601-2-18: Edition 3.0 2009-08 (clause 202 only) 9-114 IEC 60601-2-19 Edition” “IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 CSV; IEC 60601-2-10; EN 60601-2-10; CAN/CSA-C22.2 No. 60601-2-10; IEC 60601-2-22; EN 60601-2-22; CAN/CSA-C22.2 No. 60601-2-22 excluding 201.12.1.101, 201.12.4.2” “IEC 60601-2-10 Edition 2.1 2016-04 17-16 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”

Labs
8
Primary AB
A2LA8 labs

Accredited Labs

Element Materials Technology Irvine

Irvine, CA, US

Scope

IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 CSV; IEC 60601-2-10; EN 60601-2-10; CAN/CSA-C22.2 No. 60601-2-10; IEC 60601-2-22; EN 60601-2-22; CAN/CSA-C22.2 No. 60601-2-22

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UL LLC

Novi, MI, US

Scope

IEC 60601-2-10 Edition 2.1 2016-04 (clause 202 only) 17-16 IEC 60601-2-16 Edition 5.0 2018-4 (clause 202 only) 9-121 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

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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 60601-2-10; IEC 60601-2-10 Edition 2.1 2016-04; IEC 60601-2-10 Edition 2.2 2023-01 Consolidated Version; IEC 60601-2-16; IEC 60601-2-16 Edition 5.0 2018-4; IEC 60601-2-18; IEC 60601-2-18 Edition 3.0 2009-08; IEC 60601-2-22; IEC 60

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F2 Labs

Middlefield, OH, US

Scope

IEC 60601-2-10 Edition 2.1 2016-04 (Section(s) 201.17/202) 1; IEC 60601-2-11 Edition 3.0 2013-01 (Section(s) 201.17/202) 1; ANSI AAMI IEC 60601-2-16:2018 (Section(s) 201.17/202) 1; IEC 60601-2-18: Edition 3.0 2009-08 (Section(s) 201

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-10 Edition 2.1 2016-04 17-16 IEC 60601-2-11 Edition 3.0 2013-01 12-255 IEC 60601-2-16 Edition 5.0 2018-4 9-121 ANSI AAMI IEC 60601-2-16:2018 9-121 IEC 60601-2-17 Edition 3.0 2013-11 12-272 IEC 60601-2-18 Edition 3.0 2009-08

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-2-10; Hemodialysis Equipment IEC 60601-2-16; Endoscopic Equipment IEC 60601-2-18;

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-2-10 Edition 2.1 2016-04 17-16 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 3.1 201

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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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