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ISO/IEC 17025 directory

IEC 80601-2-30 Accredited Testing Labs in United States

7 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 80601-2-30 testing. From the accredited scope text: “IEC 80601-2-30 (Automated Non-Invasive BP)” “IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30 (excluding 201.15.3.5); 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/CS” “IEC 80601-2-30 Edition 1.1 2013-07 3-123 ANSI AAMI IEC 80601-2-30:2018 3-123 IEC 60601-2-34 Edition 3.0 2011-05 3-115 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Con” “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. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4”

Labs
7
Primary AB
A2LA7 labs

Accredited Labs

Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

Scope

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. 2.0 (2005), clause 36; ISO 14117 (2012) sections 4 and 5; ISO 14708-1 (2014) claus

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Element Materials Technology Irvine

Irvine, CA, US

Scope

IEC 80601-2-30; EN 80601-2-30; ANSI/AAMI/IEC 80601-2-30 (excluding 201.15.3.5); 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 80

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Intertek Testing Services NA

Duluth, GA, US

Scope

IEC 80601-2-30 (Ed. 1.1, Ed. 2.0); ANSI/AAMI/IEC 80601-2-30:2018; IEC 80601-2-35 (Ed. 1 + Am 1) (excluding cl 201.8.8.4.101); IEC 80601-2-49 (Ed. 1); IEC 80601-2-60 (Ed. 1, Ed. 2); ISO 80601-2-61 (Ed. 1, Ed. 2); ISO 80601-2-67 (Ed. 2);

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 80601-2-30 (Ed 1.1, Ed 2); IEC 80601-2-30 Edition 2.0 2018-03; IEC 60601-2-34; IEC 60601-2-34 Edition 4.0 2024-10; IEC 60601-2-34 Edition 3.0 2011-05; IEC 60601-2-41; IEC 60601-2-46; IEC 60601-2-49; IEC 80601-2-49; IEC 80

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 80601-2-30 (Automated Non-Invasive BP)

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 80601-2-30 3-123 ANSI AAMI IEC 80601-2-30 3-123 ISO 80601-2-55 1-140 ISO 80601-2-56 6-421 ISO 80601-2-61 1-139 IEC 60601-1 19-49 IEC 60601-2-39 9-149 IEC 60601-2-52 6-489 IEC 60601-2-35 6-483 IEC 80601-2-60 4-262

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TUV SUD America

San Diego, CA, US

Scope

IEC 80601-2-30 Edition 1.1 2013-07 3-123 ANSI AAMI IEC 80601-2-30:2018 3-123 IEC 60601-2-34 Edition 3.0 2011-05 3-115 ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021 19-46 IE

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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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