Draft Details

1 Scope

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.