This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International Standard does not take into consideration the DIALYSIS FLUID control system
of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY
SYSTEMS. It does however take into consideration the specific safety requirements of such
HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
This International Standard specifies the minimum safety requirements for HAEMODIALYSIS
EQUIPMENT. These devices are intended for use either by medical staff or for use by the
PATIENT or other trained personnel under the supervision of medical expertise.
This International Standard includes all ME EQUIPMENT that is intended to deliver a
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering
from kidney failure.
The particular requirements in this International standard do not apply to:
– EXTRACORPOREAL CIRCUITS;
– DIALYSERS;
– DIALYSIS FLUID CONCENTRATES;
– water treatment equipment;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of IEC 60601-1.
NOTE See also 4.2 of IEC 60601-1:2005.
___________
1 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.