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prSSH EN ISO 8536-16:2025

Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO 8536-16:2025)

General information

40.20     Feb 9, 2026

40.60    May 11, 2026

DPS

DPS/KT 205

European Norm

11.040.20  

Scope

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

Life cycle

NOW

IN_DEVELOPMENT
prSSH EN ISO 8536-16:2025
40.20 DIS ballot initiated: 12 weeks
Feb 9, 2026

Related project

Adopted from EN ISO 8536-16:2025 IDENTICAL

Adopted from ISO 8536-16:2025 IDENTICAL

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