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 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.
Secondary aims of ISO 1135-5:2015 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 red cell and plasma blood components.
Platelet components should not be transfused under pressure using these sets.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.
Legislation related to this standard
WITHDRAWN
EN ISO 1135-4:2012
PUBLISHED
EN ISO 1135-5:2015
60.60
Standard published
Dec 23, 2015
IN_DEVELOPMENT
prEN ISO 1135-5
