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 does not apply to: ¾ð extracorporeal blood circuits; ¾ð plasmafilters; ¾ð haemoperfusion devices; ¾ð vascular access devices; ¾ð blood pumps; ¾ð pressure monitors for the extracorporeal blood circuit; ¾ð air detection devices; ¾ð systems to prepare, maintain or monitor dialysis fluid; ¾ð systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. ¾ð reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.