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MEDICAL DEVICES

[MEDIZINPRODUKTE]

EPTIS factsheet 271159 | Last revision 2020-10-23 | 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 Sterilization is considered as a procedure for elimination of living microorganisms and their dormant states (e.g. spores) in objects and materials (e.g. foodstuffs). This proficiency testing is designed to qualitatively check the sterility of foodstuffs in packaging materials (e.g. tinned food). Extraction by simulated application (reference method) in water; Exhaustive extraction; Extraction of the samples with water; Qualitative determination of medical devices e.g. by DSC or FTIR; semi-quantitative identification of the material surface; Extraction and determination of formaldehyde content in medical devices; Testing with the extreme value solution (ISO 10993-14 part 4.4)
Keywords
Product groups Health care / medical devices
Testing fields Microbiology
Technical details
Test item Tested property Testing method
Medical devices testing for sterilization: ISO 11737-1
Surface test for aerobic total count (Bioburden test)
Yeasts -
Moulds -
Spores -
Tests for in vitro cytotoxicity ISO 10993-5:2009
Testing the germ tightness of packaging materials -
Identification of microorganisms using MALDI-ToF -
Microbiological analysis of endoscopes -
-
Qualitative characterization of medical devices (ISO 10993-18) -
Quantitative characterization of medical devices (ISO 10993-18) using X-ray fluorescence analysis -
Determination of the elements using XRF -
Quantitative characterization of medical devices (ISO 10993-18) - Formaldehyde -
Formaldehyde -
Ethylene oxide sterilization residuals (ISO 10993-7) -
CAS 75-21-8 (Ethylene oxide) -
CAS 107-07-3 (Ethylene chlorohydrin) -
CAS 75-21-8 (Ethylene oxide) -
CAS 107-07-3 (Ethylene chlorohydrin) -
Extraction of metals from medical devices (ISO 10993-12) -
Cadmiun -
Arsenic -
Iron -
Lead -
Copper -
Aluminium -
Nickel -
Mercury -
Zinc -
Identification and quantification of degradation products from ceramics (ISO 10993-14) -
Mass of the filter residue and mass of the dissolved material -
Quantitative determination of the elements in the test solution -
Detection of loss of mass in polymeric medical devices (ISO 10993-13) -
Loss of mass of the sample in the test solution water -
Accelerated degradation test (ISO 10993-1 point 4.2) at 70°C -
Real-time degradation test (ISO 10993-1 point 4.3) at 37°C -
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 350-450 €
Regularly operated Yes (several times p.a., dep. on sample and parameters)
Year of first operation 2017, 2018, 2020, 2021
Contact details of the PT provider
Provider Contact person
DRRR - Deutsches Referenzbüro für Ringversuche und Referenzmaterialien GmbH
Bodmanstraße 4
87435 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.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.21