99.60 Withdrawal effective Dec 23, 2015
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
ISO 1135-4:2011 specifies requirements for single-use transfusion 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 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.
Legislation related to this standard
WITHDRAWN
EN ISO 1135-4:2011
WITHDRAWN
EN ISO 1135-4:2012
99.60
Withdrawal effective
Dec 23, 2015