scope:

This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.

This International Standard is not applicable to:

- extracorporeal blood circuits;

- plasmafilters;

- hemoperfusion 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 hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration;

- reprocessing procedures and equipment.

NOTE Requirements for the extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters are specified in ISO 8638.