ISO 8637:2010 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.
