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ISO/IEC 17025 directory

IEC 60601-2-30 Accredited Testing Labs in Germany

8 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform IEC 60601-2-30 testing. From the accredited scope text: “IEC 60601-2-30:1999); Deutsche Fassung EN 60601-2-30:2000 VDE 0750-2-30 (2000-12)⊗ DIN EN IEC 60601-2-31 : 2021-07 Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die Basissich” “IEC 60601-2-30 : 1999-12 ⊗ Medical electrical equipment - Part 2-30: Particul ar requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitori” “IEC 60601-2-30:1999); German version EN 60601-2-30:2000 VDE 0750-2-30 (2000-12) ⊗ DIN EN IEC 80601-2-49:2020-10 Medical electrical eq uipment - Part 2-49: Particular requirements for the basic safety”

Labs
8
Primary AB
DAKKS8 labs

Accredited Labs

ELMAC GmbH EMV-Labor J. Bühne

Bondorf, DE

Scope

IEC 60601-2-30 : 1999-12⊗ Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-34 : 2011-05

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VDE Prüf- und Zertifizierungsinstitut

Offenbach am Main, DE

Scope

IEC 60601-2-30 : 1999-12⊗ Medical electrical equipment - Part 2-30: Particular requirement s for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-31 : 2020-01

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CSA Group Bayern

Plattling, DE

Scope

IEC 60601-2-30 : 1999-12 ⊗ Medical electrical equipment - Part 2-30: Particul ar requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment CAN/CSA-C22.2 NO. 60601-

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EMCE GmbH Ingenieurbüro für EMV-Prüfungen und Schaltungsentwicklung

Burgrieden, DE

Scope

IEC 60601-2-30 : 1999-12 ⊗ Medical electrical equipment - Part 2-30: Particul ar requirements for the safety, including essential performance, of automatic cyclic non-invasive blood pressure monitoring equipment IEC 60601-2-35 : 1996-10

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

IEC 60601-2-30:1999); Deutsche Fassung EN 60601-2-30:2000 VDE 0750-2-30 (2000-12)⊗ DIN EN IEC 60601-2-31 : 2021-07 Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die Basissicherheit einschließlich der wesentl

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Eurofins Product Service

Reichenwalde, DE

Scope

IEC 60601-2-30:1999); German version EN 60601-2-30:2000 VDE 0750-2-30 (2000-12) ⊗ DIN EN IEC 80601-2-49:2020-10 Medical electrical eq uipment - Part 2-49: Particular requirements for the basic safety and essential performance of multif

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steep GmbH EMV-Zentrum

Bonn, DE

Scope

IEC 60601-2-30 : 1999-12⊗ Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-30 : 1995-03⊗

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CEcert

Wismar, DE

Scope

according to DIN EN ISO/IEC 17025:2018 Valid from : 27.02.2025 Date of issue : 16.05.2025 Page 22 of 35 This document is a translation. The definitive version is the original German annex to the accreditation certificate. per

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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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