DIN Standards Committee Health Technologies
DIN EN ISO 11663
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014); German version EN ISO 11663:2015
Qualität von Konzentraten für die Hämodialyse und verwandte Therapien (ISO 11663:2014); Deutsche Fassung EN ISO 11663:2015
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis
