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ISO/IEC 17025 directory

IEC 80601-2-60 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 80601-2-60 testing. From the accredited scope text: “IEC 80601-2-60; EN 80601-2-60; CAN/CSA-C22.2 No. 80601-2-60, (excluding 201.10.4); ISO 80601-2-61; EN 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2” “IEC 80601-2-60 (Ed. 1, Ed. 2); ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2); ISO 80601-2-69 (Ed. 2); IEC 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (excluding Vicat Softening and” “IEC 80601-2-60; IEC 80601-2-60 Edition 2.0 2019-06; ISO 80601-2-61; ISO 80601-2-61 Edition 2.0 2017-12 (Corrected Version 2018-02); IEC 80601-2-77; IEC 80601-2-77 Edition 1.0 2019-07; IEC 80601-2-77 E” “IEC 80601-2-60 Edition 2.0 2019-06 4-262 ISO 80601-2-12 Second edition 2020-02 1-146 ISO 80601-2-12 Third edition 2023-11 1-187 ISO 80601-2-56 Second Edition 2017-03 6-421 IEC TS 60601-4-2 Edition 1.0”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Element Materials Technology Irvine

Irvine, CA, US

Scope

IEC 80601-2-60; EN 80601-2-60; CAN/CSA-C22.2 No. 80601-2-60, (excluding 201.10.4); ISO 80601-2-61; EN 80601-2-61; CAN/CSA-C22.2 No. 80601-2-61; IEC 80601-2-77:2019+A1:2023; EN IEC 80601-2-77:2021+A1:2023; ANSI/AAMI/IEC 80601-2-77:202

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 80601-2-60 (Ed. 1, Ed. 2); ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2); ISO 80601-2-69 (Ed. 2); IEC 62366; IEC 62366-1; IEC 62304 (Ed. 1 + Am 1) Laboratory (excluding Vicat Softening and CRT/High Vacuum) IEC 61010-

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 80601-2-60; IEC 80601-2-60 Edition 2.0 2019-06; ISO 80601-2-61; ISO 80601-2-61 Edition 2.0 2017-12 (Corrected Version 2018-02); IEC 80601-2-77; IEC 80601-2-77 Edition 1.0 2019-07; IEC 80601-2-77 Edition 1.1 2023-1

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F2 Labs

Middlefield, OH, US

Scope

IEC 80601-2-60 Edition 2.0 2019-06 (Section(s) 201.17/202) 1; ISO 80601-2-61 Second Edition 2017-12 1 (Corrected version 2018-02) (Section(s) 201.17/202) 1; ISO 80601-2-69 Second Edition 2020-11 (Section(s) 201.17/202) 1; ISO 80601-2-70

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

Multiparameter Patient Monitoring Equipment IEC 60601-2-49:2011; EN 60601-2-49:2015; CSA C22.2 No. 60601-2- 49:2011; Safety of Medical Beds IEC 60601-2-52:20091; EN 60601-2-52:2010 + AC:2011 + A1:2015; CAN/CSA C22.2 No. 60601-

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TUV SUD America

San Diego, CA, US

Scope

IEC 80601-2-60 Edition 2.0 2019-06 4-262 ISO 80601-2-12 Second edition 2020-02 1-146 ISO 80601-2-12 Third edition 2023-11 1-187 ISO 80601-2-56 Second Edition 2017-03 6-421 IEC TS 60601-4-2 Edition 1.0 2024-03 19-50

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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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