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prEN ISO 8536-13 rev

Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact prEN ISO 8536-13 rev

General information

10.99   New project approved   Oct 14, 2025

CEN

CEN/TC 205 Non-active medical devices

European Norm

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

PUBLISHED
EN ISO 8536-13:2024

NOW

IN_DEVELOPMENT
prEN ISO 8536-13 rev
10.99 New project approved
Oct 14, 2025




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