ISO/CD TR 8417.2

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
: В стадии разработки

Этап
: Проект комитета принят для регистрации в качестве проекта международного стандарта [30.99]
Версия
: 1
Технический комитет :
ISO/TC 76

ICS :
11.040.20
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