prEN ISO 1135-5

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023)

Publication date:   Oct 12, 2023

Scope

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.
Platelet components should not be transfused under pressure using these sets.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Related legislation

Legislation related to this standard