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IEC 60601-2-16 Haemodialysis, Haemodiafiltration and Haemofiltration Equipment Testing

Medical electrical equipment – Part 2-16: basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16 Scope:

IEC 60601 2 16 and EN 60601 2 16 testing applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment.

IEC 60601-2-16 testing 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.

EN 60601-2-16 testing 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 medical electronic 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:

  • Extracoporeal circuits;
  • Dialyzers;
  • Dialysis fluid concentrates;
  • Water treatment equipment;
  • Equipment used to perform peritoneal dialysis (see IEC 60601-2-39).


If a clause or sub-clause is specifically intended to be applicable to medical electronic equipment only, or to medical equipment systems only, the title and content of that clause or sub-clause will say so. If that is not the case, the clause or sub-clause applies both to medical electronic equipment and to medical equipment systems, as relevant.

Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-16 except in 7.2.13 and 8.4.1 of IEC 60601-1.

Keystone Compliance assists manufacturers with IEC 60601-2-16 and EN 60601-2-16 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-16 test lab needs.