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Dimensional verification ISO 25539

Normative References  



ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses.

ISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.

ASTM F2081: Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents.

With this test, the stent systems dimensions are determined for verification of design specifications. The dimensions include, but not limited to, the outer diameter, guidewire lumen diameter and useable length.. This information can be used to evaluate the dimensional compatibility between the stent system and the recommended accessory devices listed in the product IFU.  


Implant Testing - Dimensional verification ISO 25539