Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
|Publication Date:||1 April 2008|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
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.
NOTE See also 4.2.
This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.
In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-13).
This particular standard specifies the minimum safety requirements for single PATIENT HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT (as defined in 2.101). These devices are intended for use either by medical staff or under the supervision of medical expertise, including HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT operated by the PATIENT. These particular requirements do not apply to
- EXTRACORPOREAL CIRCUITS,
- DIALYSING FLUID CONCENTRATES,
- water purification EQUIPMENT,
- EQUIPMENT used to perform peritoneal dialysis (see IEC 60601-2-39).
2) IEC 61010 (all parts), Safety requirements for electrical equipment for measurement, control, and laboratory use
3) ISO 14708-1, Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer