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ISO/IEC 17025 directory

IEC 60601-2-37 Accredited Testing Labs in Germany

12 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-37 testing. From the accredited scope text: “IEC 60601-2-37:2007 + A1: 2015); Deutsche Fassung EN 60601-2-37:2008 + A11:2011 + A1:2015 DIN EN 60601-2-37 : 2012-05 ⊗ - Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Si” “IEC 60601-2-37 : 2007-08 Medical electrical equipment - Part 2-37: Particular requirements for the basic sa fety and essential performance of ultrasonic medical diagnostic and monitoring equipment + A” “IEC 60601-2-37 : 2007-08 IEC 60601-2-39 : 2018-04 I EC 60601-2-40 : 2016-08 IEC 60601-2-46 : 2016-08 IEC 60601-2-47 : 2012-02 IEC 60601-2-49 : 2011-020 IEC 60601-2-50 : 2020-09 DAkkS Deutsche Akkredit” “IEC 60601-2-37 Monitoring devices Checking compliance with general and specific requirements - multifunctional patient monitoring devices DIN EN IEC 80601-2-49 DIN EN 60601-2-49 ⊗ IEC 60601-2-49 ⊗ - D”

Labs
12
Primary AB
DAKKS11 labs

Accredited Labs

E & C Testlab GmbH (Engineering & Certification Testlab GmbH)

Trossingen, DE

Scope

IEC 60601-2-37 : 2007-08 Medical electrical equipment - Part 2-37: Particular requirements for the basic sa fety and essential performance of ultrasonic medical diagnostic and monitoring equipment + Amendment 1 : 2015-06

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

China, DE

Scope

IEC 60601-2-37; IEC 60601-2-37 Edition 2.1 2015; IEC 60601-2-37 Edition 3.0 2024-07; CSA C22.2 No. 60601-2-37; EN 60601-2-37 IEC 62359; IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION; EN 62359 IEC 60601-2-57; IEC 60601-2-5

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TÜV Technische Überwachung Hessen GmbH EMV-Labor

Kassel, DE

Scope

IEC 60601-2-37:2007-08 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment + Amendment 1:2015-06 IEC 60601-2-38:1996-

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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 60601 -2-37:2007 + A1:2015 EN 60601-2-37/A1:20

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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. DIN EN 60601-2-37 : 2016-11 Medizinische elektrische Geräte – Teil 2 -37: Besondere Festlegungen für die Sicherheit ei

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CSA Group Bayern

Plattling, DE

Scope

IEC 60601-2-37:2007 + A1:2015); Deutsche Fassung EN 60601-2-37:2008 + A11:2011 + A1:2015 VDE 0750-2-37:2016-11 DIN EN 60601-2-37 : 2012-05 ⊗ - Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit eins

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-2-37:2007 + A1:2015); Deutsche Fassung EN 60601-2-37:2008 + A11:2011 + A1:2015 DIN EN 60601-2-37 : 2012-05⊗ - Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlich

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

Straubing, DE

Scope

IEC 60601-2-37 : 2007-08 IEC 60601-2-39 : 2018-04 I EC 60601-2-40 : 2016-08 IEC 60601-2-46 : 2016-08 IEC 60601-2-47 : 2012-02 IEC 60601-2-49 : 2011-020 IEC 60601-2-50 : 2020-09 DAkkS Deutsche Akkreditierungsstelle Medical electrical equipme

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PHOENIX TESTLAB

Blomberg, DE

Scope

IEC 60601-2-37:2007 + A1: 2015); Deutsche Fassung EN 60601-2-37:2008 + A11:2011 + A1:2015 DIN EN 60601-2-37 : 2012-05 ⊗ - Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentli

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

Republic Of, DE

Scope

Department Standard/in house procedure/Version Title of standard or in house procedure (deviations/modifications of standard) Test area/ reductions MED IEC 80601 -2-30:2009 +AMD1:2013 SIST EN 80601-2-30:2010+ +AMD1:2015 IEC 80

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SLG Prüf- und Zertifizierungs

Hartmannsdorf, DE

Scope

IEC 60601-2-37 Monitoring devices Checking compliance with general and specific requirements - multifunctional patient monitoring devices DIN EN IEC 80601-2-49 DIN EN 60601-2-49 ⊗ IEC 60601-2-49 ⊗ - Devices for monitor

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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 -2-37:2016 VDE 0750-2-37:2016 Medica

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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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