Overview

This part of the IEC 60601 series of international standards applies to medical electrical equipment for the hemodialysis, hemofiltration, or hemodiafiltration treatment of a patient, hereinafter referred to as hemodialysis equipment, regardless of the duration and location (for example, a hospital or domestic environment) of the treatment. The scope includes not only hemodialysis devices intended for use either by medical staff or under the supervision of medical experts, but also those operated by the patient. This document specifies requirements for the basic safety and essential performance of hemodialysis equipment. The scope of this document does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid control system of haemodialysis equipment. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. Furthermore, equipment used to perform peritoneal dialysis, dialyzers, dialysis fluid concentrates, and bags containing pre-mixed dialysis fluid, dialysis water supply systems, and central supply systems for dialysis fluid concentrates are not covered by the scope of this document. The standard differs from DIN EN IEC 60601-2-16 (VDE 0750-2-16):2020-05 as follows: a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020; b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021; c) including the information given in the document 62D/1771A/INF regarding 201.11.8; d) including withdrawn IEC PAS 63023 [17] as Annex CC; e) including SECURITY (CYBERSECURITY) requirements; f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags; g) improvements for labelling; h) other minor technical improvements; i) editorial improvements. This document is typically used by developers, manufacturers, and certifiers of hemodialysis equipment.

Responsible national committee

DKE/GUK 804.11 - Apparate für extrakorporale Zirkulations- und Infusionstechnik