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ISO/TR 8417:2024

Risk management of particulate contamination for devices with intravascular access ISO/TR 8417:2024

Publication date:   Oct 3, 2024

General information

60.60 Standard published   Oct 3, 2024

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

Technical Report

11.040.20   Transfusion, infusion and injection equipment

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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.

Life cycle

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PUBLISHED
ISO/TR 8417:2024
60.60 Standard published
Oct 3, 2024