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ISO/IEC 17025 directory

ISO 80601-2-55 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform ISO 80601-2-55 testing. From the accredited scope text: “ISO 80601-2-55 Medical electrical equipment – Part 2-55: Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors ISO 80601-2-56 Medical electrical equipment” “ISO 80601-2-55 Second Edition 2018-02 1-140 ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] 1-184 IEC 60601-2-25 Edition 2.0, 2011-10 3-105 ANSI AAMI IEC 60601-2-25:2011/(R)2016 3-105 IEC” “ISO 80601-2-55 (2018), clause 202; 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-” “ISO 80601-2-55 Second edition 2018-02 1-140 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”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

ISO 80601-2-55 (2018), clause 202; 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 6060

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Intertek Testing Services NA

Duluth, GA, US

Scope

ISO 80601-2-55 Second edition 2018-02 1-140 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-

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Intertek Testing Services NA

Kentwood, MI, US

Scope

ISO 80601-2-55 (Ed. 1; Ed. 2 + Am1); ISO 80601-2-55 Second Edition 2018-02; ISO 80601-2-61 (Ed. 1; Ed. 2); ISO 80601-2-61 Second Edition 2017-12 (Corrected Version 2018-02); ISO 80601-2-67 (Ed. 1; Ed. 2); ISO 80601-2-69 (Ed. 1;

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BUREAU VERITAS CONSUMER PRODUCTS SERVICES

Littleton, MA, US

Scope

ISO 80601-2-55 Medical electrical equipment – Part 2-55: Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors ISO 80601-2-56 Medical electrical equipment – Part 2-56: Particular Requireme

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

ISO 80601-2-55:20181; EN ISO 80601-2-55:2018; Clinical Thermometers for Body Temperature Measurement 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 Oximet

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TUV SUD America

San Diego, CA, US

Scope

ISO 80601-2-55 Second Edition 2018-02 1-140 ISO 80601-2-55 Second edition 2018-02 [Including AMD1:2023] 1-184 IEC 60601-2-25 Edition 2.0, 2011-10 3-105 ANSI AAMI IEC 60601-2-25:2011/(R)2016 3-105 IEC 60601-2-27 Edition 3.0 2011-03 3-126

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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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