Final Draft International Standard
ISO/DTR 8417
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/DTR 8417
ISO/DTR 8417
Edición 1
© ISO 2024
Final Draft
International StandardResumen
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.
Ciclo de vida
¿Tiene alguna duda?
Consulte nuestras Ayuda y asistencia
Atención al cliente
+41 22 749 08 88
Horario de asistencia:
De lunes a viernes - 09:00-12:00, 14:00-17:00 (UTC+1)