ISO/TR 8417:2024

International Standard   Current Edition · Approved on 03 October 2024

Risk management of particulate contamination for devices with intravascular access

ISO/TR 8417:2024 Files

English 9 Pages
Current Edition
31.0 BHD

ISO/TR 8417:2024 Scope

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.

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