[Testing methods for the characterization of catheter balloons and lumina]

The present paper reports on the characterization of catheter balloons and lumina on the basis of such known parameters as residual volume, compliance, burst pressure and flow rate, with the aim of developing standards, test methods and testing equipment as well as standards. These are becoming ever more important with the coming into force of the EC directive on medical products [7] and the law governing medical products in Germany [13], which requires manufacturers to specify the properties of their products. Our testing concept is based on a commercially available machine that subjects materials to alternating extension and compression forces over the long-term, to which we added a special hydraulic module. Using the multimedia technology we achieved a real time superimposition of the volume-diameter curve on the balloon. The function of the testing device and method is demonstrated on dilatation catheters. Our initial results reveal compatibility with the requirements of the 1% accuracy class. Use of this methodology for comparative testing of catheters and quality evaluation is recommended.