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ISO/IEC 17025 directory

IEC 60601-2-16 Accredited Testing Labs in Germany

5 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-16 testing. From the accredited scope text: “IEC 60601-2-16 : 2020-05 Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations-” “IEC 60601-2-16 VDE 0750-2-16:2020-05 Medical electrical equipment - Part 2 -16: ParDcular requirements for basic safety and essenDal performance of haemodialysis, haemodiafiltraDon and haemofiltraDon eq” “IEC 60601-2-16; IEC 60601-2-16 Edition 5.0 2018-4; IEC 60601-2-16:2025; ANSI AAMI IEC 60601-2-16; ANSI AAMI IEC 60601-2-16:2018; CSA C22.2 No. 60601-2-16; EN IEC 60601-2-16 IEC 60601-2-10; IEC 60601-2” “IEC 60601-2-16 DIN EN 60601-2-24 IEC 60601-2-24 DIN EN IEC 60601-2-39 - Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten - Infusionspumpen und - steuergeräte - Peritoneal-Dialyse-Geräte Be”

Labs
5
Primary AB
DAKKS4 labs

Accredited Labs

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

China, DE

Scope

IEC 60601-2-16; IEC 60601-2-16 Edition 5.0 2018-4; IEC 60601-2-16:2025; ANSI AAMI IEC 60601-2-16; ANSI AAMI IEC 60601-2-16:2018; CSA C22.2 No. 60601-2-16; EN IEC 60601-2-16 IEC 60601-2-10; IEC 60601-2-10 Edition 2.1 2016-04; IEC

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TÜV Technische Überwachung Hessen GmbH EMV-Labor

Kassel, DE

Scope

IEC 60601-2-16 DIN EN 60601-2-24 IEC 60601-2-24 DIN EN IEC 60601-2-39 - Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten - Infusionspumpen und - steuergeräte - Peritoneal-Dialyse-Geräte Beatmungs-, Sauerstof

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TÜV Rheinland Japan Ltd. Yokohama Laboratories Global Technology Assessment Center

Japan, DE

Scope

IEC 60601-2-16 VDE 0750-2-16:2020-05 Medical electrical equipment - Part 2 -16: ParDcular requirements for basic safety and essenDal performance of haemodialysis, haemodiafiltraDon and haemofiltraDon equipment. A Product Safety IEC

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-2-16 : 2020-05 Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601

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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 -2-7:2000 VDE 0750-2-7:2000 Medical el

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This page is a fixed slice of the register: every IEC 60601-2-16 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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