This standard will be used to evaluate and quantify the safe limits of particulate generation from intravascular medical devices intended to access the peripheral, coronary, and/or neurovasculature such as catheters, guidewires, stroke, and intracranial aneurysm treatment devices. Particles that may be generated from these devices during their use pose a serious embolic risk to the patients that may cause stroke or death.
There is a need for this new standard because we do not have a well established understanding of how the quantity and size of particulates that can be introduced into the vasculature from medical devices used during interventional procedures in the peripheral, coronary, and neurovasculature can affect patient safety. As the minimally invasive clinical community develops, there are a greater number of medical devices being developed that are used in the vascular systems, which makes it crucial to understand how particulate generation is attributed to device safety. The proposed standard can be used by medical device manufacturers and FDA to demonstrate and evaluate acceptable performance criteria for the quantity and size of foreign particulates that can be introduced into the vascular systems by intravascular devices as they are tested in a simulated use bench top model.
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: F04.31
Staff Manager: Kathleen Chalfin
Date Initiated: 09-14-2017
Technical Contact: Samuel Raben