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ISO/IEC 17025 directory

ASTM F1980 Accredited Testing Labs in Germany

10 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform ASTM F1980 testing. From the accredited scope text: “ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Device” “ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices German Federal Health Gazette 04/94, S. 274-278 : 1994-04 Testing the activity of surface disinfec” “ASTM F1980 – 21 Standard Guide for Accelerated Agin g of Sterile Barrier Systems for Medical Devices ASTM F2003 – 02(2022) Standard Guide for Accelerate d Aging of Ultra-High Molecular Weight Polyethy” “ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 2021 Medical Devices ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by 2011 (reapproved 2019) Int”

Labs
10
Primary AB
DAKKS9 labs

Accredited Labs

Endolab Mechanical Engineering

Riedering, DE

Scope

ASTM F1980 – 21 Standard Guide for Accelerated Agin g of Sterile Barrier Systems for Medical Devices ASTM F2003 – 02(2022) Standard Guide for Accelerate d Aging of Ultra-High Molecular Weight Polyethylene ASTM F2009 – 20 Standard Test M

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UL International

Neu-Ulm, DE

Scope

DIN EN ISO 18562-4: 2020-05 Beurteilung der Biokompatibilität der Atemgaswege bei medizinischen Anwendungen - Teil 4: Prüfungen für herauslösbare Substanzen in Kondensaten (ISO 18562-4:2017) DIN EN ISO 20795-1: 2013-06 Zahnheilkunde – Ku

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PAConsult

Hamburg, DE

Scope

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 2021 Medical Devices ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by 2011 (reapproved 2019) Internal Pressurization (Bubble

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TÜV SÜD Product Service

Frankfurt/Main, DE

Scope

ASTM F1980 – 21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ASTM F2054/F2054M – 13 (Reapproved 2020) Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressuriza

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HygCen Germany

Schwerin, DE

Scope

ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices German Federal Health Gazette 04/94, S. 274-278 : 1994-04 Testing the activity of surface disinfectants for the disinfection of tuber

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Zwisler Laboratorium GmbH

Reichenau, DE

Scope

Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Mikrobiologisch- hygienische Prüfungen Sterilbarriere- und Verpackungssysteme Verpackungsmaterialien Prüfung zum Nachweis der Übereinst

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BFSV Verpackungsinstitut Hamburg

Hamburg, DE

Scope

DIN EN 60068 -2-27 2010 -02 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock DIN EN 60068 -2-64 2009 -04 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance

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GBA Medical Device Services

Gilching, DE

Scope

ASTM F1980 : 2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Device

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SCUS GmbH

Dresden, DE

Scope

1.5. Klimaprüfung an Packstücken, Ladeeinheiten und Verpackungen bzw. Packmi;eln bei definierter Temperatur und definierter rela@ver Feuchte [Flex B] ASTM D 4332 2022 Standard Practice for Conditioning Containers, Packages, or Packagin

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SpineServ GmbH & Co.KG

Ulm, DE

Scope

ASTM F1980 Test Technology: Parameters: Test Method(s): Static Testing: Static Load Static Torsion Stroke Angular Displacement (± 0.4 to ± 20,000) N (± 0.02 to ± 50) Nm (0 to 550) mm (0 to ±1,800) deg

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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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