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DIN Standards Committee Health Technologies

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.

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