DIN EN ISO 25539-2:2013-05

This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular devices and the methods of test that will enable their evaluation. It is the second part of a proposed three-part standard. ISO 25539-1 addresses endovascular prostheses and ISO 25539-3 will address vena cava filters. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements of this document. The Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the potential device and clinical failure modes. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment.