Overview

This 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. Moreover, the standard provides guidance on specifications relating to the quality and performance of materials used in infusion sets. The new edition was required as the European Annex ZA regarding the relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices had to be re-structured due to new formal requirements by the EU Commission. There are no modifications with respect to DIN EN ISO 8536-5:2012 in terms of content. This document (EN ISO 8536-5:2013) has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) 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).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment