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.