ISO/TR 8417:2024

Risk management of particulate contamination for devices with intravascular access

This document

—???? provides information on the determination of particulate loads;

—???? reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices.

This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids.

NOTE??????????? For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.

Edition	2024
Published Date	2024
Published By	International Standardization Organisation/Technical Reference
Page Count	9