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 presenta-tion of the results as individual values or as distribution pictures.

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

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 tests of 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.

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.