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 35 proficiency tests from the following disciplines are available to choose from:
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
immunological, molecular biological & microbiological tests
In addition to the already established microbiological, cultural methods, e.g. for testing of sterilization (bioburden method for various microorganisms), identification of microorganisms and testing of microbial tightness, proficiency tests for the analysis of dialysis water and water from dental units will also be offered for the first time in 2025. The portfolio of proficiency tests for “in-vitro methods” has also been expanded extensively, so that in addition to testing for in-vitro cytotoxicity, proficiency tests e.g. for in-vitro irritation and sensitization of the skin or the detection of endotoxins are now also offered.
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The following matrices are available:
For the year 2025, we have included the following new proficiency tests in the program:
Medical devices - TOC und THC
The proficiency test covers the determination of water-soluble total organic carbon (TOC) and solvent-soluble hydrocarbons (total hydrocarbon, THC). Possible performance of the test e.g. with ISO 19227:2018 or comparable methods.
Medical devices - in vitro skin irritation (ISO 10993-23)
The samples are extracted in accordance with ISO 10993-23 under conditions specified by us. Irritation is tested with both the polar and the non-polar extract using the EpiDerm or the EpiSkin model. The viability determined using the MTT assay is tested qualitatively (pass / not pass)
Microbiological analysis of dialysis water
Proficiency test series for testing water for haemodialysis and related therapies for microbiological requirements.
Part 1: Aerobic total count 36 °C, Aerobic total count 20 °C according to e.g. ISO 23500, ISO 6222, mineral/table water regulation and drinking water regulation.
Part 2: Ps. aeruginosa according to e.g. ISO 16266, mineral/table water regulation and drinking water regulation.
Part 3: E.coli, Coliforms according to e.g. ISO 9308, mineral/table water regulation and drinking water regulation.
Microbiological analysis of water from dental units
A new proficiency test series for the quantitative analysis of water quality in dental units is also being offered. Similar to proficiency tests in dialysis water, the parameters aerobic total count 36 °C (ISO 6222) and Ps. aeruginosa (e.g. ISO 16266, Min/TafelWV and TrinkwV) are also offered here, as well as the parameter Legionella spp. (ISO 11731 and TrinkwV).
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”.