BS EN ISO 1135-4:2025 - TC

This standard BS EN ISO 1135-4:2025 - TC Tracked Changes. Transfusion equipment for medical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

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.