prEN ISO 1135-4

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023) prEN ISO 1135-4

Publication date:   Oct 12, 2023

General information

45.99 Dispatch of FV draft to CCMC   May 12, 2024


CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment



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This document specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with 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 a range of cellular 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 legislation

Legislation related to this standard


Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle


EN ISO 1135-4:2015


prEN ISO 1135-4
45.99 Dispatch of FV draft to CCMC
May 12, 2024