Proficiency testing “Medical devices”
Our proficiency test program for medical devices offers laboratories a wide range of proficiency tests. Medical devices include all instruments, substances, objects, machines and software that are used in humans for physical therapeutic and diagnostic purposes. More than 50 proficiency tests from the following disciplines are available to choose from:
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e.g. for sterilization residues (e.g. ethylene oxide, TOC and THC), residues and contaminants (e.g. metals and elements), qualitative and quantitative characterization, migration, extraction
From 2027, we will also be expanding our range of services to include a PT for the analysis of medical devices for PFAS and for determining the nickel content of spectacle frames.
immunological, molecular biological & microbiological tests
e.g. sterility (bioburden method for various microorganisms, enumeration and detection), microbiological testing of water from healthcare, identification of microorganisms, detection of endotoxins and protein residues, various in vitro methods (e.g., cytotoxicity and skin irritation)
For 2027, we are expanding our proficiency testing portfolio to include the examination (enumeration and detection) of non-sterile medical devices for specific microorganisms such as S. aureus, P. aeruginosa, E. coli, C. albicans, etc., in accordance with Ph. Eur. 2.6.12 and Ph. Eur. 2.6.13.
As cell culture models are used in numerous in vitro procedures, we have added several initial proficiency tests to our portfolio for 2027 under the keyword ‘cell culture’, which address fundamental topics such as contamination testing of culture media (detection of myoplasma, mycobacteria and moulds) and cell counting of mammalian cells. These proficiency tests are suitable for all laboratories that routinely work with cell cultures, such as testing and research laboratories or biobanks.
Furthermore, we have added two new proficiency tests to our programme for assessing the biocompatibility of medical devices: genotoxicity and haemocompatibility.
The following matrices are available:
Reference Material Medical devices:
As an addition to our proficiency tests, we offer certified reference materials. This material is available in all areas where proficiency testing is offered. The application possibilities are manifold, whether for keeping control charts, for validation between two proficiency test participations or for training of employees.
Click here to go directly to the reference material “Medical devices”.