DIN EN ISO 11663:2016-02

The text of ISO 11663:2014 has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" of the International Organization for Standardization (ISO) and adopted as EN ISO 11663:2015 by Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany).The responsible German committee is Working Committee NA 063-01-03 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Medicine (NAMed). This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. It includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document does not address the requirements for the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.