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CEI - EN 60601-2-16

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

inactive
Organization: CEI
Publication Date: 1 January 2016
Status: inactive
Page Count: 74
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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

Document History

January 1, 2018
Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
A description is not available for this item.
EN 60601-2-16
January 1, 2016
Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT....
July 1, 2000
Medical electrical equipment - Part 2: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Il presente Errata Corrige recepisce il Corrigendum emesso dal CENELEC nel dicembre 1999. In base a tale Corrigendum, la Norma CEI EN 60601-2-16 non annulla né sostituisce più la EN 50072:1992 che è...
March 1, 1999
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
Specifica le prescrizioni minime di sicurezza per sistemi o combinazioni di unità utilizzate per eseguire emodialisi, emodiafiltrazione e emofiltrazione utilizzati sia sotto la supervisione di...

References

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