prEN ISO 8536-5 rev

Infusion equipment for medical use — Part 5: Burette infusion sets for single use, gravity feed

General information

10.99 New project approved   Dec 4, 2023

CEN

CEN/TC 205 Non-active medical devices

European Norm

Scope

ISO 8536-5:2004 specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment.
ISO 8536-5:2004 also provides guidance on specifications relating to the quality and performance of materials.
In some countries, national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-5:2004.

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 8536-5:2013

NOW

IN_DEVELOPMENT
prEN ISO 8536-5 rev
10.99 New project approved
Dec 4, 2023