DIN Standards Committee Health Technologies
DIN EN ISO 8536-10
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015); German version EN ISO 8536-10:2015
Infusionsgeräte zur medizinischen Verwendung - Teil 10: Zubehörteile für Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-10:2015); Deutsche Fassung EN ISO 8536-10:2015
Overview
This part of ISO 8536 specifies requirements for accessories for single use in fluid lines and pressure infusion equipment up to a maximum of 200 kPa (2 bar) as specified in ISO 8536-4 to ensure that they are suitable for use with containers for infusion solutions and intravenous puncture devices. This specifies the requirements for sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-4. This equipment contains two-way stopcocks (2SC), three-way stopcocks (3SC), four-way stopcocks (4SC), stopcocks manifold (SM), units with injection site (UIS), units with check valve (UCV), stoppers (S) and adapters (A). This standard also contains requirements regarding the quality and performance of the materials used for the equipment. 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).
