Standard Guide for Model Development for Particulate Generation Testing of Endovascular Devices

Importancia y uso:

5.1 The evaluation of particulates from endovascular devices is a critical parameter to help ensure that the devices can be delivered to and from the treatment site with minimal unintended effects due to particulate generation.

5.2 This guide is intended for the development and design of a simulated use model for the evaluation of particulate generation by those manufacturing and/or evaluating endovascular devices.

5.3 This guide may be useful for establishment of credibility of a simulated use model as part of development testing and regulatory submission testing and filings.

Subcomité:

F04.30

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)