Institute for ImplantTechnology and Biomaterials e.V.
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Physical requirements
Overview services
Under point 4.4.2 in the EN ISO 10555-4 the freedom from leakage and damage upon catheter inflation is demanded. The examination has to be conducted at 37°C.

For this load test the laser measuring system of the Testing Laboratory is used, which is also used for the examination of the structural behavior. A particularly adapted software permits the demanded application of a dynamic alternating loading with the proven maximum pressure of the balloon catheter (RBP).

Afterwards, the catheter is examined for leakages while maintaining the maximum balloon pressure under the reflected light microscope.
laser scanner
pressure chamber