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ISO/IEC 17025 directory · Standard series

ISO 14708 Accredited Testing Labs in United States

ISO 14708, all parts: Implants for surgery - Active implantable medical devices6 laboratories in United States are accredited by A2LA for at least one part of ISO 14708. Each lab card shows which parts it holds. From the accredited scope text: “ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) clause 27; ISO 14708-4:2022 Clause 27; EN 60945 (2002) [excluding clauses 8 and 11]; IEC 60945 (2002) [excluding” “ISO 14708-1(Ed. 2, Ed. 1); ISO 14708-3 (Ed. 2, Ed. 1); ISO 14708-4 (Ed. 1) (All ISO 14708 standards exclude Cl.14.2 and Cl.22); ISO 80601-2-12 (Ed. 1, Ed. 2, Ed. 3); ISO 80601-2-55 (Ed. 1, Ed. 2 + Am” “ISO 14708-3; TSC-3000G High Temperature2 200 °C MIL-STD-202 E, F, G, (Method 108); MIL-STD-810 Base, A, B, C, D, E, F, G, H, (Method 501); SAE/USCAR 24 (Inflator Requirements) June 2004; SAE/USCAR 28” “ISO 14708-1 (clause 27 only); ISO 14708-3 (clause 27 only); ISO 14708-7 (clause 27 only); ISO 14117:2019, Sections 4-6; ANSI/USEMCSC C63.27 2021; EN 45502-1 (Section 27); EN 45502-2-1 (Section 27); EN”

Labs
6
Primary AB
A2LA6 labs
Parts of this series

Accredited Labs

Element Materials Technology Seattle - Bothell 120th

Bothell, WA, US

HoldsPart 1Part 3Part 4
Scope

ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) clause 27; ISO 14708-4:2022; EN 60945 (2002) [excluding clauses 8 and 11]; IEC 60945 (2002) [excluding clauses 8 and 11]; GR-1089-CORE, Issue 7; I

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Element Materials Technology Portland - Evergreen

Hillsboro, OR, US

HoldsPart 1Part 3Part 4
Scope

ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) clause 27; ISO 14708-4:2022 Clause 27; EN 60945 (2002) [excluding clauses 8 and 11]; IEC 60945 (2002) [excluding clauses 8 and 11]; IEC 61000-6-7

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Element Materials Technology Irvine

Irvine, CA, US

HoldsPart 1Part 3Part 4
Scope

ISO 14708-1 (2014) clause 27; ISO 14708-3 (2017-04) clause 27; ISO 14708-4 (2008-11-15) clause 27; ISO 14708-4:2022 Clause 27; EN 60945 (2002) [excluding clauses 8 and 11]; IEC 60945 (2002) [excluding clauses 8 and 11]; GR-1089-CORE, I

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Intertek Testing Services NA

Duluth, GA, US

HoldsPart 1Part 3Part 4
Scope

ISO 14708-1(Ed. 2, Ed. 1); ISO 14708-3 (Ed. 2, Ed. 1); ISO 14708-4 (Ed. 1) (All ISO 14708 standards exclude Cl.14.2 and Cl.22); ISO 80601-2-12 (Ed. 1, Ed. 2, Ed. 3); ISO 80601-2-55 (Ed. 1, Ed. 2 + Am 1); ISO 80601-2-56 (Ed. 1, Ed.2 +

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Applied Technical Services

Tempe, AZ, US

HoldsPart 3
Scope

ISO 14708-3; TSC-3000G High Temperature2 200 °C MIL-STD-202 E, F, G, (Method 108); MIL-STD-810 Base, A, B, C, D, E, F, G, H, (Method 501); SAE/USCAR 24 (Inflator Requirements) June 2004; SAE/USCAR 28 (Initiator Requirements) June 2

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TUV SUD America

San Diego, CA, US

HoldsPart 1Part 3Part 7
Scope

ISO 14708-1 (clause 27 only); ISO 14708-3 (clause 27 only); ISO 14708-7 (clause 27 only); ISO 14117:2019, Sections 4-6; ANSI/USEMCSC C63.27 2021; EN 45502-1 (Section 27); EN 45502-2-1 (Section 27); EN 45502-2-3 (Section 27); ISO 7

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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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