DIN Standards Committee Technical Fundamentals
DIN EN ISO 8536-9
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015); German version EN ISO 8536-9:2015
Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015); Deutsche Fassung EN ISO 8536-9:2015
Overview
This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC). 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).
