This document specifies requirements and test methods for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.

This document does not apply to:

—    

extracorporeal blood circuits;

—    

plasmafilters;

—    

haemoperfusion devices;

—    

vascular access devices;

—    

blood pumps;

—    

systems to prepare, maintain or monitor dialysis fluid;

—    

systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

—    

reprocessing procedures and equipment.

NOTE 1       Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2       Requirements for plasmafilters are specified in ISO 8637-3.