scope:

General

This document addresses particulate released from intravascular medical devices that have direct contact with circulating blood. It is intended to assist intravascular medical device manufacturers in defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits.

Inclusions

This document specifically includes particulate that could be acutely released into the vasculature from intravascular medical devices and accessories used with the devices. This might include particulate as a result of manufacturing, packaging, materials, coatings, and acute device use. This document only addresses particulate that might be released during acute intravascular device use, i.e., from introduction to device and accessory withdrawal.

Exclusions

This document does not address particulate released after removal of a non-implantable device or after removal of an implant's delivery system and accessories, i.e., chronic particulate release from an implanted device such as due to wear. It excludes intentional therapies in the form of particulate, for example drug coatings on balloons and embolization microspheres or beads, though their delivery systems are included.

This document specifically excludes particulate arising from the operating room or clinical environment in which the device is used.

This document does not address patient-generated particulate, such as those originating from plaque, that might be produced before, during, or following an acute device procedure. Liquids, such as lubricating fluids, are not considered to be particulate in the context of this document.

Routine monitoring of particulate levels on the device due to unintended changes in the manufacturing process or environment are not discussed in this document.