Main menu
60.60 Standard published Dec 23, 2015
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
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.
Legislation related to this standard
WITHDRAWN
EN ISO 1135-4:2012
PUBLISHED
EN ISO 1135-4:2015
60.60
Standard published
Dec 23, 2015
IN_DEVELOPMENT
prEN ISO 1135-4