Abstract

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets used together with the volumetric infusion controllers. NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Begin

2024-02-09

WI

00205398

Planned document number

prEN ISO 8536-16

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices