EN ISO 8536-13:2024

Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2024)

Publication date:   Nov 14, 2024

General information

60.60   Standard published   Sep 25, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This document specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-13:2016

NOW

PUBLISHED
EN ISO 8536-13:2024
60.60 Standard published
Sep 25, 2024

REVISED BY

IN_DEVELOPMENT
prEN ISO 8536-13 rev