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.
Directives related to this standards.
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
PUBLISHED
SSH EN ISO 1135-5:2015
IN_DEVELOPMENT
prSSH EN ISO 1135-5:2025
40.20
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Feb 9, 2026
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