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ISO/IEC 17025 directory

IEC 60601-1-8 Accredited Testing Labs in United States

10 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-1-8 testing. From the accredited scope text: “IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 5-131 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED 19-38 HA60601-1-11:20” “IEC 60601-1-8:2006 IEC 60601-1-8:2006/AMD1:2012 IEC 60601-1-8:2006/AMD2:2020 AAMI 60601-1-8:2006/A1:2012 AAMI 60601-1-8:2006/A2:2021 CAN/CSA C22.2 No. 60601-1-8-08 (R2018) Medical electrical equipment” “IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-64:2014-09 12-318 IEC 606” “IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021]; ANSI/AAMI HA60601-1-11:2015; ANSI/AAMI HA60601-1-11:2015 [Including AMD1: 2021] (The above standards exclude Clauses 10.1.2 Requirements for mech”

Labs
10
Primary AB
A2LA10 labs

Accredited Labs

Eurofins Electrical and Electronic Testing NA

Littleton, MA, US

Scope

IEC 60601-1-8 Edition 2.2 2020-07 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment IEC/EN 60601-2-18 IEC 60601-2-18 Edition 3.0 2009-08 Medical

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Intertek Testing Services NA

Duluth, GA, US

Scope

Tests: Standard(s) 2: Laboratory / Process Control / Test Equipment Products (excluding UV Radiation, Flammable Liquids, Cathode ray tubes test) (continued) UL 61010-2-040:2021, Ed. 3; UL 61010-2-051:2015, Ed. 3; UL 61010-2-051:

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Device Conformity and Testing

Devens, MA, US

Scope

IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-64:2014-09 12-318 IEC 60601-2-68 Edition 1.0 2014-09 12-319

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EUROFINS ELECTRICAL AND ELECTRONIC TESTING NA

Suite A Irvine, CA, US

Scope

IEC 60601-1-8:2006 IEC 60601-1-8:2006/AMD1:2012 IEC 60601-1-8:2006/AMD2:2020 AAMI 60601-1-8:2006/A1:2012 AAMI 60601-1-8:2006/A2:2021 CAN/CSA C22.2 No. 60601-1-8-08 (R2018) Medical electrical equipment - Part 1-9: General requirement

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Criterion, a Biotex, Inc. service

Houston, TX, US

Scope

IEC 60601-1-8 6.3.3.2 Volume of Auditory Alarm Signals and Information Signals IEC 60601-1-11; ANSI AAMI HA60601-1-11 4.2.3.1 Continuous Operating Conditions (Pressure Only) 4.2.3.2 Environmental shock to Transit-Operable ME Equipment

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021]; ANSI/AAMI HA60601-1-11:2015; ANSI/AAMI HA60601-1-11:2015 [Including AMD1: 2021] (The above standards exclude Clauses 10.1.2 Requirements for mechanical strength for

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 5-131 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED 19-38 HA60601-1-11:2015 [Including AMD1:2021] 19-47 ANSI

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-1-8; IEC 60601-1-8:2006 + A1:2012 + A2:20201; ANSI/AAMI/IEC 60601-1-8; ANSI/AAMI/IEC 60601-1- 8:2006 + A1:2012 + A2:20211; CAN/CSA C22 No. 60601-1-8; EN 60601-1-8; Requirements for Physiological Closed-Loop Controlle

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-1-8:2006 and A1:2012 General methods of measuring the performance of ultrasonic pulsed-echo diagnostic equipment JIS T 1501: 2005 Ultrasonics –Characteristic of Fields IEC 61846 Edition 1998-04; IEC 63045 Edition 2020-05;

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 5-131 ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021] 5-131 IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION 19-37 IEC 60601-1-11 Edition 2.1 2020-07 CONSOLI

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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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