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MEDICAL DEVICES

[MEDIZINPRODUKTE]

EPTIS factsheet 271159 | Last revision 2025-11-03 | URL: https://www.eptis.bam.de/pts271159 https://www.eptis.bam.de/pts271159

PT provider
PT provider DRRR - Deutsches Referenzbüro für Ringversuche und Referenzmaterialien GmbH DRRR - Deutsches Referenzbüro für Ringversuche und Referenzmaterialien GmbH
Based in Germany
Language(s) German/English
Remarks Sterility and contamination testing, In vitro procedure, Water in medical care, Surgical drapes and gowns, Non-active medical devices
Keywords
Product groups Health care / medical devices
Testing fields Microbiology
Technical details
Test item Tested property Testing method
Sterility and contamination testing Ethylene oxide residues ISO 10993-7
TOC and THC -
Testing of sterilization of medical devices ISO 11737-1
Identification of microorganisms using MALDI-ToF -
Microbiological analysis of endoscopes -
Protein residues -
Detection of endotoxins (Ph. Eur. 2.6.14) -
Sterility testing medical devices Ph. Eur. 2.6.1, ISO 11737-2
Non-active medical devices Extraction of metals from medical devices (ISO 10993-12) ISO 10993-12
Qual. characterization ISO 10993-18
Quan. characterization - XRF ISO 10993-18
Quan. characterization - Formaldehyde ISO 10993-18
Degradation products from ceramic ISO 10993-14
Loss of polymer mass ISO 10993-13
Gravim. determination extractables -
Extractables & leachables -
extraction of elements ISO 10993-12
VOC -
In vitro procedure Tests for in vitro cytotoxicity ISO 10993-5
in vitro skin irritation ISO 10993-23
in vitro skin sensitisation OECD 442E, h-CLAT
in vitro eye irritation OECD492b
Water in medical care Microbiological analysis of water from dental units ISO 10993-5
Microbiological analysis of dialysis water -
Surgical drapes and gowns microbial load EN 13795-1
microbial penetration dry EN 13795-1
microbial penetration, damp EN 13795-1
Aims of the PT scheme
Target group of participants all laboratories
Linked to specific legislation / standards
Additional, subsidiary aims validation of testing methods
Number of participants depending on the proficiency testing between 5 - 50 participants
Accredited or otherwise reviewed by a 3rd party

Accredited by A2LA (USA) and DAkkS (Germany) on the basis of ISO/IEC 17043 for part of the parameters

Operation is commissioned / requested by
Fees and frequency
Participation fee 250-600 € dep. on sample and parameters
Regularly operated Yes (several times p.a., dep. on sample and parameters)
Year of first operation 2017, 2018, 2020, 2021, 2023, 2024, 2025,2026
Contact details of the PT provider
Provider Contact person
DRRR - Deutsches Referenzbüro für Ringversuche und Referenzmaterialien GmbH
Reinhartser Straße 31
87437 Kempten
Germany

Phone: +49 (0) 831/960 8780
Fax: +49 (0) 831/960 87899
Web: http://www.drrr.de http://www.drrr.de
Dr. Ulrich Leist
Phone: +49 (0) 831/960 87878
Fax: +49 (0) 831/960 87899
Email: info@drrr.de info@drrr.de
If you find any mistakes please contact the responsible EPTIS coordinator in Germany, Mr Johannes van de Kreeke. Mr Johannes van de Kreeke.
Disclaimer & Privacy Policy
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5