Scope

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