Standard Guide for Measuring Securement of Balloon-Expandable Vascular Stent Mounted on Delivery System

Importancia y uso:

4.1 The securement of the endovascular stent on the balloon is a critical parameter to ensure that the stent is safely delivered to or from the treatment site.

4.2 This guide is intended for use by researchers and manufacturers for the development and selection of pre-test treatments, tests, and test endpoints to measure stent securement (displacement distances and dislodgment forces).

4.3 This guide may be used to investigate which practical combinations of in vitro tests best characterize clinical scenarios.

4.4 This guide should be used with discretion in choosing securement tests and evaluating results due to the myriad possible combinations of clinical conditions, failure modes, and stent delivery system designs.

4.5 This guide may be of use for developing a test for meeting Parts 2 and 3 of the requirements of EN 14299, Section 7.3.4.4 on Trackability.

4.6 This guide may be of use for developing a test to meet section VII-C-8 of CDRH Guidance document.

Subcomité:

F04.30

Referida por:

F3036-21, F3206-17

Volúmen:

13.01

Número ICS:

11.040.20 (Transfusion, Infusion)

Palabras clave:

angioplasty; artery; dislodgment; displacement; medical device; retention; securement; stent; vascular;