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ISO/IEC 17025 directory

IEC 60601-2-34 Accredited Testing Labs in Germany

9 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-34 testing. From the accredited scope text: “IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014 DIN EN 60601-2-34 : 2001-11⊗ - Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich wesentlic” “IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014” “IEC 60601-2-34 : 2011-05 IEC 60601-2-36 : 2014-04 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 : 2011-02” “IEC 60601-2-34 : 2011-05 Medical electrical equipme nt – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment CAN/CSA-C22.2”

Labs
9
Primary AB
DAKKS8 labs

Accredited Labs

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

China, DE

Scope

IEC 60601-2-34; IEC 60601-2-34 Edition 3.0 2011-05; IEC 60601-2-34:2024; CSA C22.2 No. 60601-2-34; EN 60601-2-34 IEC 60601-2-4; IEC 60601-2-4:2010; IEC 60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION; ANSI AAMI IEC 60601-2-4;

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TÜV Technische Überwachung Hessen GmbH EMV-Labor

Kassel, DE

Scope

IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014 VDE 0750-2-34:2015-01 DIN EN 60601-2-34:2001-11⊗ - Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistun

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TÜV Rheinland Japan Ltd. Yokohama Laboratories Global Technology Assessment Center

Japan, DE

Scope

IEC 60601-2-34:2008 DIN EN 60601-2- 34 :2015 VDE 0750-2-34:2015 Medical electrical equipment - Part 2 -34: ParDcular requirements for the basic safety and essenDal performance of invasive blood pressure monitoring equipment. A

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CSA Group Bayern

Plattling, DE

Scope

IEC 60601-2-34 : 2011-05 Medical electrical equipme nt – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment CAN/CSA-C22.2 NO. 60601-2-34:12 IEC 60601-2-34 :

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Element Materials Technology Straubing GmbH Element Materials Technology Straubing

Straubing, DE

Scope

IEC 60601-2-34 : 2011-05 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment IEC 60601-2-34 : 2000-10⊗ - Medical electrical equi

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014 DIN EN 60601-2-34 : 2001-11⊗ - Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich wesentlicher Leistungsmerkmale von invasiven

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Intertek Deutschland

Kaufbeuren, DE

Scope

IEC 60601-2-34:2011); Deutsche Fassung EN 60601-2-34:2014

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

Straubing, DE

Scope

IEC 60601-2-34 : 2011-05 IEC 60601-2-36 : 2014-04 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 Deutsch

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SLG Prüf- und Zertifizierungs

Hartmannsdorf, DE

Scope

IEC 60601-2-34:2000); German version EN 60601- 2-34:2000 DIN EN IEC 60601-2-35 : 2022-10 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of patient warming blankets, mats

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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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