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ISO/IEC 17025 directory

IEC 60601-2-5 Accredited Testing Labs in United States

6 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-2-5 testing. From the accredited scope text: “IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-6 Edition 2.1 2016-04 6-423 IEC 60601-2-8 Edition 2.1 b:2015 12-301 IEC 60601-2-10 Edition 2.1 2016-04 17-16 IEC 60601-2-11 Edition 3.0 2013-01 12-” “IEC 60601-2-5: Edition 3.0 2009-07 (clause 201.17 only) 12-205 IEC 60601-2-6 Edition 2.1 2016-04 (clause 202 only) 6-423 IEC 60601-2-10 Edition 2.1 2016-04 (clause 202 only) 17-16 IEC 60601-2-16 Editi” “IEC 60601-2-57 Edition 1.0 2011-01; IEC 60601-2-57; EN 60601-2-57; CAN/CSA-C22.2 No. 60601-2-57, (excluding 201.6.1.102, 201.10.103, 201.13.1.101); IEC 60601-2-62:2013; EN 60601-2-62:2015; CAN/CSA-C22” “IEC 60601-2-5: Edition 3.0 2009-07 (Section(s) 201.17/202) 1; ANSI AAMI IEC 60601-2-50 Edition 2.1 2016-04; (Section(s) 201.17/202) 1; IEC 60601-2-50 Edition 3.0 2020-09 (Section(s) 201.17/202) 1; IEC”

Labs
6
Primary AB
A2LA6 labs

Accredited Labs

Element Materials Technology Irvine

Irvine, CA, US

Scope

IEC 60601-2-57 Edition 1.0 2011-01; IEC 60601-2-57; EN 60601-2-57; CAN/CSA-C22.2 No. 60601-2-57, (excluding 201.6.1.102, 201.10.103, 201.13.1.101); IEC 60601-2-62:2013; EN 60601-2-62:2015; CAN/CSA-C22.2 No. 60601-2-62:15, (excludi

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UL LLC

Novi, MI, US

Scope

IEC 60601-2-5: Edition 3.0 2009-07 (clause 201.17 only) 12-205 IEC 60601-2-6 Edition 2.1 2016-04 (clause 202 only) 6-423 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

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-2-5; IEC 60601-2-5 Edition 3.0 2009-07 (The above standards exclude Clause 201.10.102 Unwanted Ultrasound Radiation, Clause 201.12 Accuracy of controls and instruments and protection against hazardous outputs);

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F2 Labs

Middlefield, OH, US

Scope

IEC 60601-2-5: Edition 3.0 2009-07 (Section(s) 201.17/202) 1; ANSI AAMI IEC 60601-2-50 Edition 2.1 2016-04; (Section(s) 201.17/202) 1; IEC 60601-2-50 Edition 3.0 2020-09 (Section(s) 201.17/202) 1; IEC 60601-2-52 Edition 1.1 2015-03 CONS

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-6 Edition 2.1 2016-04 6-423 IEC 60601-2-8 Edition 2.1 b:2015 12-301 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 5.0 201

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-62 Edition 1.0 2013-07 12-281

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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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