DIN EN ISO 8536-5:2012-01

The standard specifies requirements for types of single-use, gravity feed burette infusion sets of 50 ml, 100 ml and 150 ml nominal capacity for medical use in order to ensure compatibility of use with containers for infusion solutions and intravenous equipment. The standard also provides guidance on specifications relating to the quality and performance of materials used in infusion sets.
The new edition DIN EN ISO 8536-5 has become necessary as ISO 8536-5:2004 has been adopted within the framework of the harmonization procedure under EC Directive 93/42/EEC as European harmonized standard EN ISO 8536-5:2011. There are no modifications of the content with regard to DIN ISO 8536-5:2006 apart from editorial adaptations and the complementation of the European foreword and Annex ZA on the relationship between the standard and the mentioned directive.
This document (EN ISO 8536-5:2011) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use", in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., 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 the Medical Standards Committee (NAMed).