scope:

This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans. This lnternational 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 dialysate, - systems used to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration, - reprocessing procedures and equipment.