Project No.FprEN ISO 1135-4
TitleThis document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components. NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
Registration number (WIID)75002
ScopeThis document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components. NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
StatusIzstrādē
ICS group11.040.20