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FprEN ISO 8536-5

Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed (ISO/FDIS 8536-5:2026) FprEN ISO 8536-5

Publication date:   Sep 3, 2026

General information

50.20   Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Sep 3, 2026

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

Buying

Draft

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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
FprEN ISO 8536-5
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Sep 3, 2026




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