Diverse tests

Finite element analyses (FEA)

The Finite Element Method (FEM) or the Finite Element Analysis (FEA) serves to determine the tensions, elongations or tem-peratures in prefabricated parts, components and products. Based on geometric data and/or CAD models, this analytical, computer-based calculation method permits structural and/or thermal analyses and optimisations as well as the presentation of the results as individual values or as distribution pictures.

Please read more on "Finite Element Analysis" in our Newsletter No. 8

Titrimetric analyses

This analysis permits to calculate an unknown quantity of a dissolved substance after its reaction to an appropriate reagent solution, to measure the exact volume of reagent used, and to take into account the content of the effective substance. The addition of a reagent with a known chemical efficiency (titre) permits to quantitatively convert the substance to be determined from an exactly defined chemical initial state into an equally defined final state.

Density of solids and liquids

Determination of the density following the principle of Archimedes (measurement of the lifting force). The density of a solid is determined using a liquid of known density. The sample is weighed in air and in the liquid separately. The density is calculated from the two measurements.

The density of a liquid is determined using a displacer of known volume. The displacer is weighed in air and in the unknown liquid separately. The density is calculated from the two measurements.

Determination of the pH value

Serves to determine the acid and/or the base value (pH value between 0 and 14) of an aqueous solution.

Climatic chamber tests

The climatic chamber test serves to condition, precipitate and age samples, components and prefabricated parts on defined climatic conditions (temperature, humidity) in order to assess their resistance and/or implement possible subsequent tests.

Washing, sterilization and cleaning test for medical devices

It serves to verify and validate the application requirements of medical devices regarding washing, sterilization and clean-ing, handling and aging. Investigations may include determination of residual contamination, material aging, stress-cracking susceptibility, corrosion or operability according to standards or customers specification.

Crack detection / penetrant testing

Liquid penetrant examination to detect flaws with openings to the surface (cracks, overlaps, wrinkles and pores) for all materi-als that are resistant to the penetrant and do not have high porosity.

Systematic literature reviewing (ISO 10993-1)

Search and critical evaluation of relevant literature on medical, material and process related topics based on customer specifications.

Advisory, planning of investigations and validation

Consulting services and training regarding all technical and scientific expertise and tests, in which the RMS Foundation is involved through its research activities, studies and services themselves. Investigation planning of surgical instruments and implants. Advice on validations.

Reprocessing validations for medical devices

Reprocessing of reusable medical devices means in particular cleaning, disinfecting, checking functionality, packaging, sterilisation and storage. The efficacy of the manufacturer’s reprocessing instruction is tested for the worst-case scenario, using BCA method for residual protein quantification. If necessary, the appropriate number of reprocessing cycles over the lifespan of a medical device can be evaluated.

Packaging testing

Testing of packaging (blister, peel bags) for seal strength using tensile testing and leak detection by dye penetration and bubble emission.