Medical devices Testing Labs in Germany
5 laboratories in Germany are accredited by DAKKS under ISO/IEC 17025 to perform Medical devices testing. Common methods used to test Medical devices in Germany: iso-11737-1, iso-11737-2, en-iso-9001. Most frequently tested analytes in this matrix in Germany: Additives, Bioburden, Endotoxins. Accredited providers include NAMSA Laboratory Services, PAConsult, HygCen Germany, CleanControlling Medical GmbH & Co. KG, Deutsches Referenzburo fur Ringversuche und Referenzmaterialien GmbH (DRRR GmbH). Sites located in Obernburg, Hamburg, Schwerin, Emmingen-Liptingen, Kempten.
Accredited Labs
This certificate annex is only valid together with the written accreditation certificate and reflects the status as indicated by the date of issue. The current status of any given scope of accreditation can be found in the directory of acc
Anlage zur Akkreditierungsurkunde D-PL-11130-01-01 Gültig ab: 25.09.2025 Ausstellungsdatum: 25.09.2025 Seite 25 von 27 ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 2021 Medical Devices AST
Annex to the Partial Accreditation Certificate D-PL-18818-02-02 Valid from: 22.08.2023 Date of issue: 07.12.2023 page 29 of 31 SOP 16-008 Rev. 006 Soiling of test specimens with internal laboratory test soils and soils according
Annex to the Partial Accreditation Certificate D-PL-19887-01-02 Valid from : 30.01.2024 Date of issue : 04.06.2024 Page 9 of 11 devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) ISO 17664-2: 20
(A2LA Cert. No. 5494.01) Revised 10/18/2024 Page 5 of 16 MATRIX FREQUENCY PARAMETERS PROFICIENCY TESTING SCHEMES2 Medical devices At least once a year Bacteria Yeasts Molds Sterility Testing for sterilization of m
Top methods used to test Medical devices in Germany
Top analytes for Medical devices in Germany
- Additives (1)
- Bioburden (1)
- Endotoxins (1)
- Free Nh2 Groups Of Blood Proteins (1)
- Il-18 (1)
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.