En proceso de publicación
Technical ReportISO/TR 8417
Risk management of particulate contamination for devices with intravascular access
Reference number
ISO/TR 8417
ISO/TR 8417
Edition 1
2024-10
2024-10
© ISO 2024
En proceso de publicación Technical Report
ISO/TR 8417
83166
En proceso de publicación
(Edición 1, 2024)
Pasos finales de producción (hasta siete semanas).
Resumen
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.
