En cours de publication
Rapport techniqueISO/TR 8417
Gestion des risques de contamination particulaire pour les dispositifs d'accès intravasculaire
Numéro de référence
ISO/TR 8417
ISO/TR 8417
Edition 1
2024-10
2024-10
© ISO 2024
En cours de publication Rapport technique
ISO/TR 8417
83166
En cours de publication
(Edition 1, 2024)
Étapes finales du processus d’élaboration (jusqu’à sept semaines).
Résumé
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.
