Abstract

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.

Begin

2021-10-22

WI

00205371

Planned document number

FprEN ISO 1135-5

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

draft standard

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO/FDIS 1135-5:2025)
2025-02
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previous edition(s)

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
2015-12

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