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ISO/IEC 17025 directory

ISO 80601-2-56 Accredited Testing Labs in United States

8 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 80601-2-56 testing. From the accredited scope text: “ISO 80601-2-56 Medical electrical equipment – Part 2-56: Particular Requirements for the Basic Safety and Essential Performance of clinical thermometers for body temperature measurement IEC/EN 60601-2” “ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; ISO 80601-2-61 (2011), clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4 and 5; ISO 14708-1 (2014) clause 27; I” “ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30, clause 202; ISO 80601-2-61 (2011), clause 202; IEC 60601-2-” “ISO 80601-2-56 Second edition 2017-03 6-421 IEC 80601-2-60 Edition 2.0 2019-06 4-262 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) 1-139 ISO 80601-2-69 Second edition 2020-11 1-148”

Labs
8
Primary AB
A2LA8 labs

Accredited Labs

Element Materials Technology Seattle - Bothell 120th

Bothell, WA, US

Scope

ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; ISO 80601-2-61 (2011), clause 202; ISO 9919 Ed. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4 and 5; ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; IS

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Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

ISO 80601-2-56, clause 202; ISO 80601-2-61 (2017), clause 202; IEC 80601-2-58:2024; IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30, clause 202; ISO 80601-2-61 (2011), clause 202; IEC 60601-2-62:2013, clause 202; ISO 9919 Ed

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Intertek Testing Services NA

Duluth, GA, US

Scope

ISO 80601-2-56 Second edition 2017-03 6-421 IEC 80601-2-60 Edition 2.0 2019-06 4-262 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) 1-139 ISO 80601-2-69 Second edition 2020-11 1-148 ISO 80601-2-70 Second edition 2020-

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Intertek Testing Services NA

Kentwood, MI, US

Scope

ISO 80601-2-56; ISO 80601-2-56 Edition 2.0 2017-03 [Including AMD1:2018]; IEC 80601-2-58; IEC 80601-2-58 Edition 2.0 2014-09; IEC 80601-2-58 Edition 3.0 2024-03; IEC 80601-2-60; IEC 80601-2-60 Edition 2.0 2019-06; ISO 80601-

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F2 Labs

Middlefield, OH, US

Scope

ISO 80601-2-56 Second Edition 2017-03 (Section(s) 201.17/202) 1; IEC 80601-2-59 Edition 2.0 2017-09 (Section(s) 201.17/202) 1; IEC 80601-2-59 Edition 2.1 2023-01 CONSOLIDATED VERSION; IEC 80601-2-60 Edition 2.0 2019-06 (Section(s) 201.

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BUREAU VERITAS CONSUMER PRODUCTS SERVICES

Littleton, MA, US

Scope

ISO 80601-2-56 Medical electrical equipment – Part 2-56: Particular Requirements for the Basic Safety and Essential Performance of clinical thermometers for body temperature measurement IEC/EN 60601-2-57 Medical Electrical Equipment - P

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

ISO 80601-2-56:20171; EN ISO 80601-2-56:2017; ISO 80601-2-56:2017 + A1:2018; Dental Equipment ISO 80601-2-60:2019; Pulse Oximeter Equipment ISO 80601-2-61:20171 (Corrected 2018); EN ISO 80601-2-61:2019; IEC 60601-1, Edition

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TUV SUD America

San Diego, CA, US

Scope

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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