Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance

Importancia y uso:

5.1 Upon deployment of a stent or endovascular prosthesis, the device is intended to maintain the patency of the vascular vessel. In order to maintain vessel patency, the device must deform within the in-vivo loading environment without a flow-limiting loss in lumen area. Kinking induces a severe, localized loss of lumen area, typified by a slot-like lumen shape. Device resistance to kinking can be evaluated through multiple test methods, with the appropriate selection depending on the device.

5.2 The purpose of this standard is to outline test methods to address the resistance to kinking of stents and endovascular prostheses. In the case where no kinking is observed, the radius at which a predefined narrowing criterion (for example, 50 % diameter reduction) occurs may be considered as the kink radius of the device.

5.3 When kink resistance properties are expected to vary along the length of the stent or endovascular prosthesis, testing should be performed at each of these sections.

5.4 This standard is not intended to evaluate the kink resistance of devices other than stents, endovascular prostheses, and scaffolds, although the specific procedures outlined here may be used if applicable.

Subcomité:

F04.30

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

endovascular prosthesis; kink; mock vessel; stent; stent graft;