Addition:
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,
- DIALYSERS,
- DIALYSING FLUID CONCENTRATES,
- water purification EQUIPMENT,
- EQUIPMENT used to perform peritoneal dialysis (see IEC 60601-2-39).