ISO/FDIS 8536-5

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

General information

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

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

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
ISO 8536-5:2004

NOW

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