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ISO/IEC 17025 directory

IEC 60601-1-11 Accredited Testing Labs in United States

14 laboratories in United States are accredited by A2LA under ISO/IEC 17025 to perform IEC 60601-1-11 testing. From the accredited scope text: “IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED 19-38 HA60601-1-11:2015 [Including AMD1:2021] 19-47 ANSI AAMI IEC 60601-2-2:2017 6-389 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-5 Edition 3.0” “IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Editi” “IEC 60601-1-11; IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version (The above standards exclude Clauses 10.1.2 Requirements for mechanical strength for non-TRANSIT-OPERABLE MEE and 10.1.3 Require” “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 IEC 61010-1 Edition 3.1 20”

Labs
14
Primary AB
A2LA14 labs

Accredited Labs

TUV SUD America - Auburn Hills

Auburn Hills, MI, US

Scope

IEC 60601-1-11 Section 4.2 Environmental; IEC 60601-1-12 Section 4.2.2 Environmental Vibration* (Including Environmental Vibration) SAE/USCAR-2; GMW3172; GMW3431; MIL-STD-810, Method 514; IEC 60601-1-11 Section 10; IEC 60068-2-

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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 60601-1-11 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 IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION 19-34

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WESTPAK

San Jose, CA, US

Scope

IEC 60601-1-11 (Section 4.2.2 & 4.2.3) High Temperature MIL-STD-810 501.7 Low Temperature MIL-STD-810 502.7 Temperature Shock MIL-STD-810 503.7 Humidity Testing MIL-STD-810 507.6; IEC 61730-2 (Clause 52), IEC 62108 (Clause 10.8), T

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Quanta Laboratories

Santa Clara, CA, US

Scope

IEC 60601-1-11 Sect 4.2.2, 4.2.3; ST/SG/AC.10/11Rev.5 Sect. UN 38.3 T1 Ingress Protection Protection against hazardous parts, foreign objects and dust Test Rod/Wire Probes, Test Sphere Probe, and Test Finger Probe; Dust chamber I

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Packaging Compliance

Kentwood, MI, US

Scope

SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 PACKAGING COMPLIANCE LABS, LLC 10 Cook Street Suite 3 Billerica MA, 01821 Ryan Ott Phone: (616) 227 - 4540 E-mail: rott@pkgcompliance.com MECHANICAL Valid To: August 31, 2

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Intertek Testing Services NA

Kentwood, MI, US

Scope

IEC 60601-1-11; IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version (The above standards exclude Clauses 10.1.2 Requirements for mechanical strength for non-TRANSIT-OPERABLE MEE and 10.1.3 Requirements for mechanical s

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ELEMENT MATERIALS TECHNOLOGY DENVER – LONGMONT

Longmont, CO, US

Scope

Test: Parameters: Test Method(s) 1: Temperature / Humidity (5 to 95) % RH BellCore GR-63-CORE 5.1.1.3 and 5.1.2; IEC 68-2-30, Test Db; MIL-STD-810E, Method 507.3; MIL-STD810F, Method 507.4; MIL-STD-810G, Method 507.5; MIL STD-

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TUV Rheinland of North America

Pleasanton, CA, US

Scope

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED 19-38 HA60601-1-11:2015 [Including AMD1:2021] 19-47 ANSI AAMI IEC 60601-2-2:2017 6-389 IEC 60601-2-2 Edition 6.0 2017-03 6-389 IEC 60601-2-5 Edition 3.0 2009-07 12-205 IEC 60601-2-6 Editi

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Applied Technical Services

Tempe, AZ, US

Scope

IEC 60601-1-11; TSC-3000G Explosive/Rapid Decompression MIL-STD-810 Base, A, B, C, D, E, F, G, H, (Method 500); RTCA/DO-160 B, C, D, E, F, G, (Section 4) Positive Pressure (Over Pressure)2 Up to 30,000 psi MIL-STD-1540 B, C, D, (Sec

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Medical Equipment Compliance Associates, LLC.

Oak Creek, WI, US

Scope

IEC 60601-1-11; IEC 60601-1-11:2015 + A1:20201; ANSI AAMI HA60601-1-11; ANSI/AAMI HA 60601-1- 11:2015 + AMD1:20211; CAN/CSA C22.2 No. 60601-1- 11; EN 60601-1-11; NBR IEC 60601-1-11; Medical Electrical Equipment and Medic

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Sigma Scientific Services

Sunrise, FL, US

Scope

IEC 60601-1-11 Edition 2.1 2020-07 General requirements for basic safety and essential performance- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical

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Element Materials Technology St. Paul

St. Paul, MN, US

Scope

IEC 60601-1-11 Xenon-Arc Light Exposure, With and Without Water ASTM D2565, G155 Vibration IEC 60068-2-64; MIL-STD-810 (Method 514) Fall Protection Devices: Anchorage Connectors for Active Fall Protection Systems AN

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TUV SUD America

San Diego, CA, US

Scope

IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION 19-38 IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 19-36 ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] 19-36 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION

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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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