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. 40 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
Starting in 2026, we will offer you a proficiency test for the examination of medical devices for volatile organic compounds (VOCs).
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 2026, we have expanded our program to include three proficiency tests for the examination of surgical drapes and gowns. The focus here is on testing for microbial contamination (including ISO 11737-1) and microbial penetration (wet and dry) in accordance with EN 13795-1.
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”.