UNE-EN IEC 60601-2-16:2019

Addition:

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 specific safety details of the

DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS

FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. 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 HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or

for use by the PATIENT or other trained personnel under medical supervision.

This International Standard includes all ME EQUIPMENT that is intended to deliver a

HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT,

independent of the treatment duration and location.

If applicable, this international standard applies to the relevant parts of ME EQUIPMENT

intended for other extracorporeal blood purification treatments.

The particular requirements in this International Standard do not apply to:

EXTRACORPOREAL CIRCUITS (see ISO 8637-2);

DIALYSERS (see ISO 8637-1);

DIALYSIS FLUID CONCENTRATES (see ISO 23500-4);

DIALYSIS WATER supply systems (see ISO 23500-2);

- CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, 4.3);

Equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).