prEN ISO 8536-4 rev

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

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 single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 8536-4:2020

NOW

IN_DEVELOPMENT
prEN ISO 8536-4 rev
10.99 New project approved
Oct 14, 2025