Standard

NS-EN ISO 1135-5:2025

Published

Corrigendums and amendments are bought separately.

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2025-12
  • Version: 1
  • Document type: NAT
  • ICS 11.040.20
  • National Committee CEN/TC 205

Legal references

EU law: 2017/745

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