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ISO/IEC 17025 directory

IEC 60601-1-8 Accredited Testing Labs in Germany

13 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-1-8 testing. From the accredited scope text: “IEC 60601-1-8:2006 + A1:2012 + A2:2020); Deutsche Fassung EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-040 - Medizinische elektrische Geräte -” “IEC 60601-1-8:2003 + A1:2006); Deutsche Fassung EN 60601-1- 8:2004 + A1:2006 DIN EN 60601-1-8 : 2004-09 ⊗ - Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit - Erg” “IEC 60601-1-8:2006 + A1:2012 + A2:2020); German version EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-04 ⊗ - Medical electrical equipment - Par” “IEC 60601-1-8 : 2012-11 Medical electrical equipmen t - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for al”

Labs
13
Primary AB
DAKKS12 labs

Accredited Labs

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

China, DE

Scope

IEC 60601-1-8; IEC 60601-1-8:2006; IEC 60601-1-8 Edition 2.1 2012-11; IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION; ANSI AAMI IEC 60601-1-8; ANSI AAMI IEC 60601-1-8:2006 and A1:2012 [Including AMD 2:2021]; CSA C22.2 No. 606

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TÜV Rheinland LGA Products

Nürnberg, DE

Scope

IEC 60601-1-8:2006 + A1:2012 + A2:2020); Deutsche Fassung EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-04 - Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für di

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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 EN 60601 -1- 6:2010/A1:2015 EN 60601-1- 6:2010/A2:2021 DIN EN 60

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VDE Prüf- und Zertifizierungsinstitut

Offenbach am Main, DE

Scope

This document is a translation. The definitive version is the original German annex to the accreditation certificate. Geräten und in medizinischen elektrischen Systemen (IEC 60601-1- 8:2006 + A1:2012); Deutsche Fassung EN 60601 -1-8:2007

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CSA Group Bayern

Plattling, DE

Scope

IEC 60601-1-8:2003 + A1:2006); Deutsche Fassung EN 60601-1- 8:2004 + A1:2006 DIN EN 60601-1-8 : 2004-09 ⊗ - Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Alarmsysteme - Allgeme

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-1-8:2006 + A1:2012 + A2:2020); Deutsche Fassung EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-040 - Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegungen f

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Eurofins Product Service

Reichenwalde, DE

Scope

IEC 60601-1-8 : 2006-10 Medical electrical equipmen t - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equ

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Intertek Deutschland

Kaufbeuren, DE

Scope

IEC 60601-1-8: 2006 + A1:2012 + A2:2020); Deutsche Fassung EN 60601-1-8:2 007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 VDE 0750-1-8:2021-12 DIN EN 60601-1-8 : 2014-04 ⊗ - Medizinische elektrische Geräte - Teil 1-8:

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cetecom advanced

Saarbrücken, DE

Scope

IEC 60601-1-8:2006 + A1:2012 + A2:2020); Deutsche Fassung EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-04 ⊗ - Medizinische elektrische Geräte - Teil 1-8: Allgemeine Festlegunge

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TÜV Rheinland Korea Ltd. Test Center, Safety of Electrical Appliances and Ergonomics

Republic Of, DE

Scope

The testing laboratory is permitted, without being required to inform and obtain prior approval from DAkkS, to use standards or equivalent testing methods listed here with different issue dates. The testing laboratory maintains a current

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SLG Prüf- und Zertifizierungs

Hartmannsdorf, DE

Scope

IEC 60601-1-8:2006 + A1:2012 + A2:2020); German version EN 60601-1-8:2007 + Cor.:2010 + A1:2013 + A1:2013/AC:2014 + A11:2017 + A2:2021 DIN EN 60601-1-8 : 2014-04 ⊗ - Medical electrical equipment - Part 1-8: General requirements for ba

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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 -1-8:2021 -12 VDE

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Kiwa Primara

Kaufbeuren, DE

Scope

IEC 60601-1-8 : 2012-11 Medical electrical equipmen t - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equ

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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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