ISO 1135-4:2004

Transfusion equipment for medical use — Part 4: Transfusion sets for single use

Scope

ISO 1135-4:2004 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.
ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.
Secondary aims of ISO 1135-4:2004 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 1135-4:2004.