ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply 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 or equipment intended 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 8637-2.