DIN EN ISO 1135-4:2012-06

The standard 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 this standard are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets. Finally, the nomenclature for components of the transfusion set is specified. With respect to DIN EN ISO 1135-4:2010-09, the dimensions in Figure 2 have been revised in Figure 2, 6.1, 8.2 and B.2 have been editorially modified and Annex ZA has been expanded with further designs. The European Standard EN ISO 1135-4 has been prepared by ISO/TC 76 "Transfusion, infusion and injection equipment for medical use", in collaboration with CEN/TC 205 "Non-active medical devices" with the participation of German experts. At DIN the responsible committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") at NAMed.