DIN Standards Committee Health Technologies
DIN EN ISO 1135-4
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010); German version EN ISO 1135-4:2010
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2010); Deutsche Fassung EN ISO 1135-4:2010
Overview
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. Furthermore, the standard shall provide guidance on specifications relating to the quality and performance of materials used in transfusion sets. Finally, it specifies the designations for transfusion set components. Basically, with respect to DIN EN ISO 1135-4:2005-03, the requirements for air inlet devices have been deleted and the clauses on the closure-piercing device and test for particulate contamination have been revised. 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") of NAMed.
Document: references other documents
Responsible national committee
Responsible european committee
CEN/TC 205 - Non-active medical devices
