BS EN ISO 1135-4:2025

This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components.

NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.