scope:

General

This technical information report (TIR) addresses vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. It is intended to assist vascular medical device manufacturers in determining the source of particulates, establishing product particulate limits, defining appropriate test methods, and assessing the clinical relevance of particulate contamination.

Inclusion

This document specifically includes particles generated as a result of manufacturing, packaging, and acute application of a vascular medical device or any accessories bundled with the device used for insertion and implementation of the product. In the absence of bundled accessories, this TIR recommends testing the device in conjunction with commonly used or suggested accessories.

Exclusion

This TIR does not address particulates that arise from degradation or wear of the device, whether these particles be either deliberate or nondeliberate. This document specifically excludes particles arising from the operating room or clinical environment in which the device might be implemented. Furthermore, the scope of this document specifically excludes visible particles that would normally be found using standard visual inspection techniques that are part of the manufacturing process. This document does not address patient-generated particles that might be produced before, during, or following implementation of the device. Liquids are not considered to be particles in the context of this document. In addition, therapeutic particles intentionally delivered are not included in this document, although characterization of these particles using methods described in this document may be appropriate.