This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device??, for use in humans.
This International Standard is not applicable to:
extracorporeal blood circuits;
plasmafilters;
haemoperfusion devices;
vascular access devices;
blood pumps;
pressure monitors for the extracorporeal blood circuit;
air detection devices;
systems to prepare, maintain or monitor dialysis fluid;
systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8638.