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ISO/IEC 17025 directory

IEC 60601-1-1 Accredited Testing Labs in Germany

9 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-1-1 testing. From the accredited scope text: “IEC 60601-1-1 : 2000); Deutsche Fassung EN 60601-1-1:2001 VDE 0750-1-1 : 2002-08⊗ DIN EN 60601-1-3 : 2021-10 Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit eins” “IEC 60601-1-1:2000); German version EN 60601-1-1:2001 DIN EN 60601-1-2 : 2022-01 Medical electrical equi pment - Part 1-2: General requirements for basic safety and essential performance - Collateral” “IEC 60601-1-1 : 2000-12 ⊗ Medical electrical equipment - Part 1-1: General r equirements for safety; Collateral standard: Safety requirements for medical electrical systems” “IEC 60601-1-1:2000; IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION; ANSI AAMI ES60601-1; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:20”

Labs
9
Primary AB
DAKKS8 labs

Accredited Labs

TÜV SÜD Certification and Testing (China) Co., Ltd. Guangzhou Branch

China, DE

Scope

IEC 60601-1-1:2000; IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION; ANSI AAMI ES60601-1; ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]; CSA C22.2 No. 60601-1; EN 60

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TÜV Rheinland Japan Ltd. Yokohama Laboratories Global Technology Assessment Center

Japan, DE

Scope

Department Standard / in house procedure / Version Title of standard or in house procedure (deviaBons /reducBons modificaBons of standard) LocaBon/ reducBons Product Safety IEC 60598 -2-20:2014 EN 60598-2-20:2015 DIN EN 60

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NEMKO

Pfinztal, DE

Scope

IEC 60601-1-1 : 2000-12 ⊗ Medical electrical equipment - Part 1-1: General r equirements for safety; Collateral standard: Safety requirements for medical electrical systems

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-1-1 : 2000); Deutsche Fassung EN 60601-1-1:2001 VDE 0750-1-1 : 2002-08⊗ DIN EN 60601-1-3 : 2021-10 Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistung

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Eurofins Product Service

Reichenwalde, DE

Scope

IEC 60601-1-1 : 2000-12 ⊗ Medical electrical equipment - Part 1-1: General r equirements for safety; Collateral standard: Safety requirements for medical electrical systems

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Intertek Deutschland

Kaufbeuren, DE

Scope

Die Akkreditierungsbegutachtung fand unter Berücksi chtigung der normativen Verweise der europäischen Regelwerke (DIN EN) statt. Die normativen Verweise der internationalen Regelwerke (IEC, ISO) wurden nicht berücksichtigt, sofern die ref

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SLG Prüf- und Zertifizierungs

Hartmannsdorf, DE

Scope

IEC 60601-1-1:2000); German version EN 60601-1-1:2001 DIN EN 60601-1-2 : 2022-01 Medical electrical equi pment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturban

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TÜV Rheinland (Shanghai) Co.,

China, DE

Scope

Department Standard / in house procedure / Version Title of standard or in-house procedure (deviations / modifications of standard) Test area / reductions Medical Equipment DIN EN 60601 -1-1:2002 VDE 0750-1-1:2002 Medical el

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Kiwa Primara

Kaufbeuren, DE

Scope

Quellenverzeichnis Regelwerke/Prüfverfahren: DIN EN 60601-1 : 2022-11 Medizinische elektrische G eräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005 + Cor1:2006

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This page is a fixed slice of the register: every IEC 60601-1-1 scope we hold for Germany. Search narrows it further by city, accreditation body, or a term from the scope text itself.

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About ISO/IEC 17025 in Germany

Deutsche Akkreditierungsstelle (DAKKS) is the primary accreditation body issuing ISO/IEC 17025 accreditation for testing laboratories in Germany.

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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