ISO/CD 8417

Résumé

This document applies to medical devices that are used to provide intravascular access to patients to deliver liquids. It - addresses the related clinical risks - gives further advice on the determination and acceptability assessment of particulate loads as amendment to the existing clauses in ISO 8536-4 - gives advice on how to perform a comprehensive risk analysis on potential particle sources and how to mitigate related risks in design, manufacturing, and application of the devices

Informations générales

État actuel
: Projet
Edition
: 1
Comité technique
: ISO/TC 76 Appareils de transfusion, de perfusion et d'injection et appareils destinés au traitement du sang à usage médical et pharmaceutique
ICS
:
11.040.20 Matériel de transfusion, de perfusion et d'injection