Work Item
ASTM WK97247

New Guide for Inspection and Acute Particulate Characterization of Delivery Systems, Catheters, and Guidewires

1. Scope

Cardiovascular Delivery Systems, Catheters, Guidewires, Non-Drug Coated Balloon Dilatation Catheters, Non-Drug Coated stent systems

Keywords

Acute Particulate; coating; integrity

Rationale

Currently there are only documents relevant to coated stent systems and drug coated balloons. This document would cover a wider range of devices and include aspects related to hydrophilic coatings that are commonly used.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: F04.30

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 12-04-2025

Technical Contact: Brian Choules

Item: 000

Ballot:

Status: