dnaSRPS EN ISO 1135-5:2022

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/FDIS 1135-5:2025)

Scope

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment.
This document also provides 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.
NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.