ISO/CD 8417

Тезис

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

Общая информация

Текущий статус
: Under development
Версия
: 1
Технический комитет
: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
ICS
:
11.040.20 Transfusion, infusion and injection equipment