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ISO/IEC 17025 directory

IEC 60601-2-63 Accredited Testing Labs in Germany

7 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-63 testing. From the accredited scope text: “IEC 60601-2-63:2012 + A1:2017 + A2:2021); Deutsche Fassung EN 60601-2-63:2015 + A1:2019 + A2:2021 DIN EN 60601-2-64 : 2018-01 Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für di” “IEC 60601-2-63 : 2012-09 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment + Amendment 1 : 2017-07 +”

Labs
7
Primary AB
DAKKS7 labs

Accredited Labs

UL International Germany

Neu-Isenburg, DE

Scope

Leistungsmerkmale von Geräten zur Stimulation von Nerven und Muskeln (IEC 60601-2-10:2012 + A1:2016); Deutsche Fassung EN 60601-2-10:2015 + A1:2016 DIN EN 60601-2-18 : 2016-10 Medizinische elektrisch e Geräte - Teil 2-18: Besondere Fes

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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 VDE 0750 -2-50: 2022 Product Safety IEC 60601 -2-52:2009 + A1:

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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. VDE 0750 -2-54:2010-05 + Ber. 1:2010 -07 + Ber. 2:2011 -12 + Ber. 3 : 2012-04 DIN EN 60601-2-57 : 2011-11 Medizinisc

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CSA Group Bayern

Plattling, DE

Scope

IEC 60601-2-63:2012 + A1:2017 + A2:2021); Deutsche Fassung EN 60601-2-63:2015 + A1:2019 + A2:2021 VDE 0750-2-63:2022-08 DIN EN 60601-2-65 : 2022-07 Medizinische elektrisch e Geräte - Teil 2-65: Besondere Festlegungen für die Sicherheit

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-2-63:2012 + A1:2017 + A2:2021); Deutsche Fassung EN 60601-2-63:2015 + A1:2019 + A2:2021 DIN EN 60601-2-64 : 2018-01 Medizinische elektrische Geräte - Teil 2-64: Besondere Festlegungen für die Sicherheit einschließlich der wese

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TÜV SÜD Product Service GmbH PS-SL-EMC / PS-SL-ENV-STR

Straubing, DE

Scope

IEC 60601-2-63 : 2012-09 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment + Amendment 1 : 2017-07 + Amendment 2 : 2021-05 IEC 60601-2-65 :

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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 -2-54:2016 VDE 0750-2-54:2016 Medica

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This page is a fixed slice of the register: every IEC 60601-2-63 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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