Testing is becoming increasingly important
Advances in medicine are enabling us to live increasingly longer. Whereas in 2005, just 20 million people in the EU were aged 80 and over, ten years later the figure had already grown to 27 million – and it is still rising. By 2050, they are expected to account for 11 percent of the total population. The many additional years of life also place new demands on the medical technology employed, such as prostheses or stents, as Elena Ciofi from TÜV SÜD Italia explains in the video.
Biocompatibility crucial
Hardly any other product has to undergo such extensive testing before it comes onto the market as a medical device. And rightly so. Because, just as a lens has to be perfectly aligned to a camera, it is crucial for the human organism that, for example, when a prosthesis is implanted it fits and harmonizes perfectly with the body. The medical device should fulfill its intended function without harming the patient. Detailed testing procedures, such as those offered by TÜV SÜD, ensure that medical devices have no toxic or immunogenic effects over the long term.
“More than 40 years’ experience in medical technology testing procedures provide the best proof of our expertise.”
Elena Ciofi
Head of Medical Device (Healthcare)
TÜV SÜD Italia
Chemical and biological procedures
A number of both biological and chemical test procedures are required in order to ensure biocompatibility. These involve for example the detection of viable microorganisms or the exclusion of potential cell damage. Only if a medical device meets all the criteria down to the very last detail, it will receive approval. And TÜV SÜD studies this very closely. With test laboratories around the globe, proven experts and state-of-the-art equipment – this has ultimately made us Europe’s biggest certifier for medical devices.
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