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This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). The European Standard has been prepared by ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany), in collaboration with CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with the participation of German experts. The responsible national 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 DIN Standards Committee Medicine (NAMed).
This document replaces DIN EN ISO 8536-8:2005-02 .