DIN EN ISO 8536-4
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010 + Amd 1:2013); German version EN ISO 8536-4:2013 + A1:2013
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010 + Amd 1:2013); Deutsche Fassung EN ISO 8536-4:2013 + A1:2013
Overview
This standard contains the German version of the European Standard EN ISO 8536-4:2013/A1:2013 which has been prepared by CEN/TC 205 "Non-active medical devices", in collaboration with ISO/TC 76 "Transfusion, infusion and injection equipment for medical use", in collaboration with German experts of Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und -geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics") at NAMed. It contains both the European A1:2013 with a revised Annex ZA as well as international Amendment 1 (Amd.1:2013) with further amendments to 9.1, 9.2, A.2, A.6 and the bibliography. Furthermore a new clause 11 on disposal has been added. The new version replaces the previous 2011 edition.
