ISO 1135-4:2015 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 ISO 1135-4:2015 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.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.
Directives 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
SRPS EN ISO 1135-4:2017
prSRPS EN ISO 1135-4:2022
10.99 New project approved
Oct 22, 2021