DIN Standards Committee Health Technologies
DIN EN ISO 23500
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014); German version EN ISO 23500:2015
Leitfaden für die Vorbereitung und das Qualitätsmanagement von Konzentraten für die Hämodialyse und verwandte Therapien (ISO 23500:2014); Deutsche Fassung EN ISO 23500:2015
Overview
The text of ISO 23500:2014 has been prepared by Technical Committee ISO/TC 150 "Implants for surgery" of the International Organization for Standardization (ISO) and as EN ISO 23500:2015 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 standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this standard functions as a recommended practice. In addition the standard addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.
Document: references 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
