Work Item
ASTM WK60511

New Test Method for Particle evaluation and characterization for neurointerventional devices.

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

particle size

Rationale

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.

Details

Developed by Subcommittee: F04.31

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 09-14-2017

Technical Contact: Samuel Raben

Item: 000

Ballot:

Status: