Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Clause 1 of the general standard1 applies, except as follows:

201.1.1 * Scope

Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.

This document 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 document 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 document 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 document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.

The particular requirements in this document do not apply to:

– EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12]2);
– DIALYSERS (see ISO 8637-1, [11]);
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);
– DIALYSIS WATER supply systems (see ISO 23500-2, [16]);
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]), described as systems for bulk mixing concentrate at a dialysis facility;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).

201.1.2 Object

Replacement:

The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HAEMODIALYSIS EQUIPMENT.