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EVS-EN ISO 1135-5:2025

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

General information

Valid from 31.12.2025
Base Documents
ISO 1135-5:2025; EN ISO 1135-5:2025
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
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.

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